PART He-P 4040
REGISTRATION OF RADIATION MACHINES, MAGNETIC RESONANCE IMAGING MACHINES
AND PROVIDERS OF SERVICES
He-P 4040.01 Purpose. This part provides for:
(a) The evaluation of the need for
shielding for new and modified ionizing radiation facilities;
(b) The process for the
registration of ionizing radiation machines;
(c) The process for the
registration of magnetic resonance imaging (MRI) machines;
(d) The process for the
registration of persons providing radiation machine or MRI servicing, or
services; and
(e) The process for the
approval of an out-of-state radiation or MRI machine to be brought into the
State of New Hampshire.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15
He-P 4040.02 Scope. This part shall apply to each person:
(a) In possession of an
ionizing radiation or MRI machine;
(b) Who wishes to dispose of or
make a change of ownership of a radiation or MRI machine;
(c) Who offers radiation or MRI
machine servicing or services; or
(d) Who wishes to bring a
radiation or MRI machine, from another state, into the State of New Hampshire.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15
He-P 4040.03 Shielding Plan
Review.
(a) Prior to new construction
or modification of existing installations utilizing ionizing radiation
machines, a review of floor plans, shielding specifications, and equipment
arrangements shall be completed as set forth in paragraphs (b)-(d) below to
ensure that, once operational, no individual will receive a dose in excess of the limits prescribed in He-P 4020.
(b) All prospective and
existing registrants shall utilize the design services of a registered service
provider as described in He-P 4040.07.
(c) Each prospective or
existing registrant may request the department of health and human
services/radiological health section (DHHS/RHS) to provide an evaluation of an
existing shielding plan review or to offer technical advice on shielding
requirements for a radiation machine installation.
(d) The following information
shall be submitted to DHHS/RHS with any request for a shielding plan review:
(1) Distances where applicable,
such as:
a. From the source of radiation
to the patient;
b. From the source of radiation
to each point for which the shielding requirement is to be calculated; and
c. From the patient to each
point for which the shielding requirement is to be calculated;
(2) The normal location(s) of
the system's radiation port;
(3) The travel and traverse
limits of the radiation beam port(s);
(4) Direction(s) in which the
useful beam will be directed;
(5) Locations of any windows, doors or other openings;
(6) The location of the
operator's booth;
(7) The location of the control
panel;
(8) The structural composition
and thickness or lead equivalent of all existing or planned walls, doors,
partitions, floor, and ceiling of the room(s) to be evaluated;
(9) The dimensions of the
room(s) to be evaluated;
(10) The type of occupancy of
all adjacent areas, including the space above and below the rooms(s), and, if
there is an exterior wall, the distance to the closest area(s) where it is
likely that an individual might be present;
(11) The make and model of the
equipment, the maximum technique factors as defined in He-P 4041, and the
output waveform;
(12) The type of examination(s)
or treatment(s) to be performed with the equipment; and
(13) Information on the
anticipated workload of the system(s) in milliampere seconds (mAs) per week, milliampere seconds being the product of the
x-ray tube current and the exposure time.
(e) After installation of a
radiation machine, the registrant shall keep the following records for review
during an inspection by DHHS/RHS until the registration is terminated:
(1) The maximum rated technique
factors, as defined in He-P 4041, of each machine;
(2) A scaled drawing of the
room in which each stationary radiation machine system is located indicating
the location of tubeheads, describing the use of each
area adjacent to the room, and specifying an estimation of the extent of
occupancy by an individual in such areas;
(3) The results of a survey for
radiation levels present at the operator's position and at pertinent points
outside the room at specified test conditions; and
(4) The shielding plan review
which shall include the type and thickness of materials, or lead equivalency,
of each protective barrier.
(f) After installation of an
MRI machine and until the registration is terminated, the registrant shall keep
the following records for review during an inspection by DHHS/RHS:
(1) A scaled drawing of the MRI
suite indicating the location of reception, patient, prescreening, control
room, MRI machine, fire extinguishers and equipment;
(2) An MRI suite safety
protocol which shall be reviewed:
a. Annually; and
b. After any change is made to
the MRI suite; and
(3) Documentation that the
local fire department is aware of the presence of MRI suite hazards in the
event of an emergency response.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15
He-P 4040.04 Registration of
Radiation or MRI Machines.
(a) Each person having
possession of any ionizing radiation or MRI machine, except those specifically
exempted in He-P 4040.06, or those applying for reciprocal recognition of an
out-of-state radiation or MRI machine in accordance with 4040.11, shall
register such machine with DHHS/RHS within 30 days after its acquisition.
(b) Each person leasing or
renting a radiation or MRI machine as defined in He-P 4041 shall be subject to
the machine registration requirements of He-P 4040.04.
(c) Application for
registration of a radiation or MRI machine shall be made on FORM DHHS/RHS A
“Application for Radiation or Magnetic Resonance Imaging Machine Registration”
(May, 2015) provided by DHHS/RHS.
(d) The registration period
shall begin on August 1 and end on July 31st of the following year.
(e) All registrations shall be
renewable as described in He-P 4040.09.
(f) No person having possession
of a radiation or MRI machine shall operate such machine or cause it to be
operated until it is registered with DHHS/RHS pursuant to He-P 4040.04.
(g) DHHS/RHS shall issue a
certificate of registration provided that the requirements of He-P 4040.04 and
the applicable fee payment required under He-P 4070.06 have been met.
(h) The registrant shall retain
the certificate of registration until it expires as per He-P 4040.08.
(i)
The registrant shall notify DHHS/RHS in writing within 15 days of any
change in the information submitted in the application for registration and
contained on the certificate of registration.
(j) The disposal or change of
ownership of any registered machine shall be made in accordance with He-P
4040.05.
(k) Each registrant shall be
responsible for radiation protection in operations with each radiation machine.
(l) Each registrant shall
prohibit any person from furnishing radiation or MRI machine servicing or
services as described in He-P 4040.07 to a radiation or MRI machine or facility
until such person provides a current certificate of registration as evidence
that they are registered with DHHS/RHS as a provider of services.
(m) No person shall assemble, install or use radiation or MRI machines unless such
machines, when properly placed in operation, meet the requirements of this
chapter.
(n) Machines purchased during
the month of July shall be registered according to He-P 4040.04(a), and shall
be assessed the applicable fee set forth in He-P 4070 during the month of
August.
(o) In addition to the requirements set forth
in He-P 4040:
(1) All radiation and MRI
machine registrants shall follow the requirements set forth in He-P 4001
through He-P 4003, He-P 4019 through He-P 4022, He-P 4041
and He-P 4045;
(2) Registrants utilizing
analytical x-ray and radiation generating devices shall be subject to the
requirements of He-P 4043;
(3) Registrants utilizing
particle accelerators shall be subject to the requirements of He-P 4044;
(4) Registrants utilizing radiation
or MRI machines for all diagnostic purposes, including veterinarians shall be
subject to the requirements of He-P 4045 and He-P 4046;
(5) Registrants utilizing
therapeutic radiation machines shall be subject to the requirements of He-P
4047; and
(6) Registrants engaged in
industrial radiographic operations shall be subject to the requirements of He-P
4034.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; amd by #9945-A, eff 6-22-11, (paras (a),
(c), & (d)-(j)); amd by #9945-B, eff 6-22-11, (para (b)); ss
by #10864, eff 6-25-15
He-P 4040.05 Disposal of or Change of Ownership of a
Radiation or MRI Machine.
(a) A machine registration shall be
non-transferable.
(b) A registrant shall submit a completed FORM
DHHS/RHS D “Certificate - Disposition or Change of Ownership of Radiation or
MRI Machine” (May, 2015) provided by DHHS/RHS when modifying the possession of
a registered machine as follows:
(1) Upon disposal of a registered machine either
by donation or disposal;
(2) Upon change of ownership of a business entity
with a registered machine(s);
(3) Upon replacement of a registered machine by a
registered service provider;
(4) Upon disposal of an originally registered
machine unable to be repaired or calibrated; or
(5) Upon the sale of a registered machine.
Source.
#10864, eff 6-25-15
He-P 4040.06 Exemptions.
(a) Any electronic equipment that produces
ionizing radiation incidental to its operation shall be exempt from the
requirements of this part provided that the dose equivalent rate averaged over
an area of 10 square centimeters does not exceed 5 μSv
(0.5 millirem) per hour at 5 centimeters from any accessible surface of such
equipment.
(b) Any radiation or MRI machine while in transit
or in storage incident thereto shall be exempt from the registration
requirements of this part.
(c) Domestic television receivers and video
display terminals shall be exempt from the requirements of this part.
(d) Permanently inoperable radiation or MRI
machines shall be exempt from the requirements of this part.
(e) Loaner machines, as defined in He-P 4041,
shall be exempt from the requirements of this part as long as
the loan does not exceed the 30 days. If
the loaner machine remains in the state after 30 days, the registrant shall
comply with He-P 4040.04, He-P 4040.05, and He-P 4070. The registrant shall submit written
notification to DHHS/RHS regardless of the duration of use of the loaner
machine. Notification shall include
registrant name, and the machine make, model, serial number
and acquisition date.
(f) Financial institutions that take possession
of a radiation or MRI machine as a result of
foreclosure, bankruptcy, or other default of payment shall be exempt from the
requirements in this part to the extent that they demonstrate that the unit is
only operable for the sole purpose of selling or leasing the unit.
(g) An individual employed by a registrant to
perform, on an in-house basis only, calibrations, equipment performance
evaluations, or minor repairs of that registrant’s diagnostic or industrial
radiation or MRI machines, shall be exempt from the service provider
registration requirements of this part, unless the individual also provides
these services to other registrants.
(h) The following shall not be exempt:
(1) Electron beam welders;
(2) Electron microscopes;
(3) Providers of radiation or MRI machines for
mobile services; and
(4) Providers of service for electronic equipment
in (a) above during testing or servicing.
(i) When the registrant of the portable radiation
machine, used solely for security-related, non-human imaging applications, is a
state agency or local government, the registrant shall be exempt from the
payment of the registration fee as required under He-P 4070.06. The registrant shall ensure that possession
and use of the radiation machine comply with all applicable requirements of
He-P 4000, New Hampshire Rules for the Control of Radiation.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P
4040.05); amd by#13280, eff 10-21-21
He-P 4040.07 Application for
Registration of Servicing and Services.
(a) Each person who is engaged
in the business of installing radiation or MRI machines, or is engaged in the
business of furnishing or offering to furnish radiation or MRI machine
servicing or services as described in He-P 4040.07(b) shall apply for
registration with DHHS/RHS prior to furnishing or offering to furnish such
services.
(b) Application for
registration of persons providing servicing or services shall be made on FORM DHHS/RHS SP “Application for
Registration as a Provider of Radiation or MRI Machine-Related Services” (May,
2015) provided by DHHS/RHS.
(c) The applicant shall specify
each applicable type of service being offered, choosing from the following:
(1) Therapy unit services as
follows:
a. Radiation therapy physicist
as required by He-P 4047.04(k); or
b. Calibration and compliance
surveys of radiation therapy units;
(2) Installation and servicing of
radiation or MRI machines, therapeutic radiation machines or radiation machines
for other use and associated radiation or MRI machine components;
(3) Radiation protection
consultation or surveys;
(4) Design of shielding or
access controls for diagnostic, therapeutic or other facilities;
(5) Calibration of radiation or
MRI machines, measurement instruments, or radiation devices;
(6) Personnel dosimetry
services; or
(7) Distribution or sales of
radiation or MRI machines.
(d) Each person applying for
registration under He-P 4040.07 shall also provide the following:
(1) A description of the
minimum education, training, and experience that the applicant will require of each individual who will provide services under this
registration, as follows:
a. For installers, relative to
radiation safety and any applicable federal or state regulations pertaining to
the manufacture, assembly, installation, acceptance
and quality control testing, and functioning of radiation or MRI machines; and
b. For radiation protection
consultants and designers of shielding and access controls, relative to
radiation safety and protection, including radiation surveys and measurement,
instrumentation, shielding, and radiation protection engineering; and
c. For qualified experts, the
individual shall:
1. Be certified in the appropriate field by the
American Board of Radiology, the American Board of Health Physics, the American
Board of Medical Physics or the American Board of
Nuclear Medicine Science; or
2. Hold a master’s or doctoral
degree in physics, biophysics, radiological physics, health physics, or medical
physics and have completed one year of documented, full time training in the
appropriate field and also one year of documented,
full time work experience under the supervision of a qualified expert in the
appropriate field. To meet this
requirement, the individual shall have performed the tasks required of a
qualified expert during the year of work experience; or
3. Receive approval from
DHHS/RHS for specific activities if he or she has:
a. A bachelor’s degree in
physics, biophysics, radiological physics, health physics, or medical physics;
and
b Completed 6 years of
documented full time training and work experience in the appropriate field;
(2) A complete list of all individuals
who will be providing services in New Hampshire under this registration;
(3) A description of the
measuring instruments to be used for the type of service to be provided and the
frequency of calibration of those instruments; and
(4) An attestation, signed and
dated by the applicant, or management representative stating: “I certify that the applicant (1) understands and shall follow the relevant requirements
of the New Hampshire Rules for the Control of Radiation (He-P 4000)
applicable to the types of servicing or services to be provided under this
registration and (2) shall adhere and require adherence to them and good
radiation safety practices.”
(e) No registered service
provider shall perform services that are not specifically stated on the
certificate of registration issued by DHHS/RHS.
(f) DHHS/RHS shall issue a
certificate of registration provided that the requirements of He-P 4040.07 and
the fee required by He-P 4070.06 have been met.
(g) The registered service
provider shall retain the certificate of registration until it expires.
(h) Registration is renewable
as described in He-P 4040.09.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; amd by #9945-A, eff 6-22-11, (paras (a)
& (c)-(e)); amd by #9945-B, eff 6-22-11, (para (b)); ss
by #10864, eff 6-25-15
He-P 4040.08 Expiration of Certificates of Registration.
(a) Each certificate of registration for
possession of a radiation or MRI machine shall expire at the end of the day on
the first July 31 after issuance of the certificate.
(b) Each certificate of registration for
servicing and services shall expire at the end of the day on the first July 31
after issuance of the certificate.
(c) The registration for any individual machine
shall terminate upon disposal, permanent removal or change of ownership, of the
machine as described in He-P 4040.05.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P
4040.07)
He-P 4040.09 Renewal of Certificates of Registration.
(a) Renewal of a certificate of registration for possession
of a radiation or MRI machine shall be made in writing prior to August 1st
of each year.
(b) The machine renewal application shall include
the following:
(1) Updated or changed information about the
radiation or MRI machine status since issuance of the most recent certificate
of registration, including any of the following:
a. Type of machine;
b. Location of machine;
c. Transfer of ownership
d. Transfer to alternate site;
e. Change in status from in use to storage;
f. Change in status from storage to in use; or
g. Addition of any radiation or MRI machine;
(2) A completed FORM DHHS/RHS A “Application for
Radiation or Magnetic Resonance Imaging Machine Registration” (May, 2015) as
required in He-P 4040.04 if any changes have been made;
(3) A completed FORM DHHS/RHS D
“Certificate-Disposition or Change of Ownership of Radiation or MRI Machine”
(May, 2015) as required in He-P 4040.05, if applicable;
(4) A check made payable to “Treasurer- State of
New Hampshire” for the appropriate fee listed in He-P 4070.06; and
(5) An attestation signed and dated by the
registrant, or a certifying officer signing on behalf of the registrant,
attesting to the following: “I, the
registrant or certifying officer signing on behalf of the registrant,
understand and shall follow the relevant requirements of the New Hampshire
Rules for the Control of Radiation (He-P 4000) and confirm that all of the
information herein is complete and accurate.”
(c) Each prospective or renewing registrant who
fails to submit the registration fee within 30 days of the date that the
application and fee are due, shall be assessed an administrative fine of $100
with the fee as described in He-P 4070.08.
(d) Renewal of registration as service providers
pursuant to He-P 4040.07 shall be made in writing prior to August 1st
of each year.
(e) The service provider application for a
renewal of registration shall include the following:
(1) A signed and dated renewal of a certificate
of registration for servicing and services shall be made on FORM DHHS/RHS-RSP
“Annual Renewal of Radiation or MRI Machine-Related Service Provider
Registration” (May, 2015) provided by DHHS/RHS;
(2) An attestation signed and dated by the
applicant, or management representative stating “I certify that the applicant
(1) understands and shall follow the relevant requirements of the New Hampshire
Rules for the Control of Radiation (He-P 4000) applicable to the types of
services or servicing to be provided under this registration and (2) shall
adhere and require adherence to them and good radiation safety practices.”; and
(3) A check made payable to “Treasurer- State of
New Hampshire” for the appropriate fee listed in He-P 4070.06.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15; ss by #10864,
eff 6-25-15
He-P 4040.10 Assembler and/or Transferor Obligation.
(a) Any person who sells, leases, transfers, lends,
disposes, assembles, or installs radiation or MRI machines shall register as a
service provider and notify DHHS/RHS within 15 days of:
(1) The name and address of persons who have
received these machines;
(2) The manufacturer, model, and serial number of
each radiation or MRI machine transferred; and
(3) The date of transfer of each machine, if
applicable.
(b) No person shall make, sell, lease, transfer,
lend, assemble, or install radiation or MRI machines or the supplies used in
connection with such machines unless such supplies and equipment, when properly
placed in operation, meet the requirements of this chapter.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P
4040.09)
He-P 4040.11 Reciprocal Recognition of Out-of-State
Radiation and MRI Machines.
(a) A person proposing to bring any radiation or MRI
machine into New Hampshire from another state, for any use, shall apply to
DHHS/RHS in writing at least 3 business days prior to use of the machine in the
state.
(b) Any radiation or MRI machine used for
demonstration purposes shall follow He-P 4040.11.
(c) Application for recognition of a person
proposing to bring an out-of-state machine into New Hampshire shall be made on
FORM DHHS/RHS-RP “Registration for Reciprocal Recognition of Out-of-State
Machines” (May, 2015) provided by DHHS/RHS.
(d) The applicant shall provide, with the
application, a fee equal to half the annual fee set out in He-P 4070.06, for
each radiation or MRI machine the applicant proposes to bring into the state
with the first application for that radiation or MRI machine in the calendar
year.
(e) The reciprocity fee required by (d) above
shall cover a period of one year from the time of application, at which time a
new fee submittal shall be required.
(f) In the event an applicant proposes
subsequently to bring into the state in the same calendar year a machine with a
higher annual fee, the applicant shall provide with the application a fee equal
to half the difference between the fees of the 2 types of machines.
(g) DHHS/RHS shall not grant approval to any
application for an out-of-state radiation or MRI machine requiring a fee, if the fee does not accompany the application.
(h) DHHS/RHS shall refund the fee accompanying
any application requiring one if it does not grant approval for that
application.
(i) The applicant
shall apply in writing for a waiver to use an out-of-state radiation or MRI
machine with less than 3-business days prior written notification.
(j) DHHS/RHS shall grant a waiver of the
3-business day application limit on determining that adherence to the limit
would endanger an individual’s or the public’s health and safety.
(k) The person entering the state under
reciprocity shall:
(1) Comply with the rules in this chapter as they
relate to radiation or MRI machines, their operators, and operations of the
machines;
(2) Supply additional information as requested by
DHHS/RHS for the purposes of protecting public and worker health and safety and
ensuring the safe use of machines within the state; and
(3) Not operate an out-of-state machine within
the state under reciprocity in excess of 180 calendar
days per year.
(l) Any radiation or MRI machine shall be subject
to unannounced inspection by DHHS/RHS during the duration of the out-of-state
recognition of reciprocal registration.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P
4040.10)
He-P 4040.12 Radiation or MRI Machines in Storage.
(a) A radiation or MRI machine shall be
categorized as a machine in storage if it meets the following conditions:
(1) The machine is registered with DHHS/RHS in
accordance with the requirements of He-P 4040.04;
(2) The machine is physically disconnected from
any source of operating electric power in one or more of the following ways:
a. By the removal of its power cord or plug, if
so equipped;
b. By the removal of its direct connection from the
facility's electrical wiring system, if so connected;
c. By the removal of its internal main fuse or
circuit breaker, if so equipped; or
d. By having its external circuit breaker or
electrical circuit disconnect locked in an electrically non-conducting
condition with a key-operated or combination lock; and
(3) The machine has at its operating control or
console a tag or label bearing the words "In storage.”
(b) The placement of a machine into the storage
status shall be recorded on FORM DHHS/RHS D “Certificate-Disposition or Change
of Ownership of Radiation or MRI Machine” (May, 2015) which shall be submitted
to DHHS/RHS. Upon approval by DHHS/RHS,
the status of the registered machine shall be changed to “in storage” while it
remains out of service.
(c) A registrant shall not put into service or
restore to service a machine registered as in storage until a completed FORM
DHHS/RHS D “Certificate-Disposition or Change of Ownership of Radiation or MRI
Machine” (May, 2015) has been submitted and the difference between the fee for
the machines in storage and the fee that would otherwise apply for such
machine, as set out in He-P 4070.06, has been paid.
(d) DHHS/RHS shall not require machines in
storage under the provisions of this section to meet the requirements in Parts
He-P 4041 through He-P 4047, for that machine type.
(e) A registered machine approved of as in storage
shall qualify for the fee specified in He-P 4070.06 for a machine in storage.
Source. #6827, eff 8-6-98; ss by #7919, eff
7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P
4040.11)
He-P 4040.13 Waivers.
(a) DHHS/RHS has found that He-P 4040 applies to
a variety of conditions and uses, and that the strict application of these
rules may result in hardship or misapplication. The purpose of these waiver
procedures is to accommodate those situations where strict adherence would not
be in the best interest of the public.
(b) Any person who is or would be directly and
adversely affected by the strict application of a rule in He-P 4040 may request
a waiver, provided that such waiver does not contravene a federal statute or
regulation, state statutory requirement, or state or federal constitutional
requirement.
(c) Any person who wishes to request a waiver
shall submit a written request for a waiver.
(d) The request for a waiver shall include the
following information:
(1) The identification of the facility or
activity to which the request relates;
(2) The specific citation to the He-P 4040 rule
from which a waiver is sought;
(3) A full explanation of why a waiver is being
requested;
(4) A full explanation of any alternate
procedure, method, or other activity that is sought to be substituted for the
procedure, method, or other activity that is required by the rule from which a
waiver is being sought;
(5) The limit of duration requested for the
waiver; and
(6) A full explanation of why the person believes
that having the waiver granted will not adversely impact the public health or
safety, the environment, or property.
(e) All requests for a waiver shall be submitted
to DHHS/RHS.
(f) Where a request for a waiver relates to an
application for a registration, the person requesting the waiver shall submit
the request as part of such application, or as soon thereafter as the person
identifies the need for the request.
(g) DHHS/RHS shall grant a request for a waiver
if the requesting party demonstrates that:
(1) The waiver shall not result in an adverse
effect to public health or safety, the environment, or property; and
(2) Strict compliance with the applicable section
of He-P 4040 rule:
a. Will result in
an adverse effect to the public health or safety, the environment, or property;
or
b. Is technologically infeasible.
(h) DHHS/RHS shall send written notification to
the person requesting the waiver of the determination on the request. If the
waiver is submitted as part of the registration application and is granted, it
shall become part of the registration document.
Source. #10505, eff 1-11-14; ss by #10864, eff
6-25-15 (from He-P 4040.12)
PART
He-P 4041 USE OF RADIATION MACHINES:
DEFINITIONS
He-P 4041.01 Scope.
The definitions in He-P 4041.02 shall be in addition to the definitions
in He-P 4003.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10806, eff 3-28-15
He-P 4041.02 Definitions.
(a) “Accessible surface” means the external
surface of the enclosure or housing of the radiation-producing machine as
provided by the manufacturer.
(b) “Accessory component” means a component which
is:
(1) Used with diagnostic x-ray systems, such as a
cradle or film changer, that is not necessary for the compliance of the system
with applicable provisions of He-P 4041 but which requires an initial
determination of compatibility with the system; or
(2) Necessary for the compliance of the system
with applicable provisions of He-P 4041, but which may be interchanged with a
similar compatible component without affecting the system’s compliance, such as
one of a set of interchangeable beam-limiting devices; or
(3) Compatible with all x-ray systems with which
it may be used and that does not require compatibility or installation
instructions, such as a table top cassette holder.
(c) “Added filtration” means any filtration which
is in addition to the inherent filtration.
(d) “Air kerma (K)”
means the kinetic energy released in air by ionizing radiation, and is
determined as the quotient of dE by dM, where dE is the sum of the
initial kinetic energies of all the charged ionizing particles liberated by
uncharged ionizing particles in air of mass dM, and
is expressed in the SI unit of joule per kilogram, and the special name the
“gray” (Gy).
(e) “Air kerma rate
(AKR)” means the air kerma per unit time.
(f) “Aluminum equivalent” means the thickness of
type 1100 aluminum alloy for which the nominal chemical composition is 99.00 percent
minimum aluminum, 0.12 percent copper which affords the same attenuation, under
specified conditions, as the material in question.
(g) “Annual” means a period of
time or an event happening once a year.
(h) “Articulated joint” means a joint between 2
separate sections of a tabletop which provides the capacity of one of the
sections to pivot on the line segment along which the sections join.
(i) “Assembler” means
any person engaged in the business of assembling, replacing, or installing one
or more components into an x-ray system or subsystem and includes the owner of
an x-ray system or his or her employee or agent who assembles components into
an x-ray system that is subsequently used to provide professional or commercial
services.
(j) “Attenuation” means the reduction of exposure
rate upon passage of radiation through matter.
(k) “Attenuation block” means a block or stack,
having dimensions 20 centimeters by 20 centimeters by 3.8
centimeters, of type 1100 aluminum alloy or other materials having
equivalent attenuation.
(l) “Automatic exposure control (AEC)” means a
device which automatically controls one or more technique factors in order to obtain at a pre-selected location(s) a required
quantity of radiation. The term includes
devices such as phototimers and ion chambers.
(m) “Automatic exposure rate control (AERC)”
means a device which automatically controls one or more technique factors in order to obtain at a pre-selected location(s) a required
quantity of radiation.
(n) “Backscatter” means the scattering of
radiation or particles in a direction opposite to that of the incident radiation
due to reflection from particles of the medium traversed.
(o) “Backscatter system” means a security
screening system that makes use of radiation scattered or deflected from an
object or person to form an image of the scattering object or person.
(p) “Beam axis” means a line from the source
through the center of the x-ray field.
(q) “Beam-limiting device” means a device which
provides a means to restrict the dimensions of the x-ray field.
(r) “Beam monitoring system” means a system
designed to detect and measure the radiation present in the useful beam.
(s) “Bone densitometry system” means a medical
device which uses electronically-produced ionizing radiation to determine the
density of bone structures of human patients.
(t) “Calibration” means:
(1) The determination of the response or reading
of an instrument relative to a series of known radiation values over the range
of the instrument;
(2) The determination of the radiation dose or
exposure rate at a designated distance from a radiation source under specified
conditions of measurement;
(3) To check, adjust, or systematically
standardize to graduations of a quantitative measuring instrument; and
(4) To check, adjust or systematically bring
radiation-producing equipment into manufacturer’s specifications.
(u) “C-arm Fluoroscope” means a fluoroscopic
x-ray system in which the image receptor and x-ray tube housing assembly are
connected or coordinated to maintain a spatial relationship. A C-arm fluoroscope system allows a change in
the direction of the beam axis with respect to the patient without moving the
patient.
(v) “Cantilevered tabletop” means a tabletop
designed such that the unsupported portion can be extended at least 100
centimeters (cm) beyond the support.
(w) “Cassette holder” means a device, other than
a spot film device, that supports and/or fixes the position of an image
receptor during a radiographic exposure.
(x) “Cephalometric device” means a device
intended for the radiographic visualization and measurement of the dimensions
of the human head.
(y) “Certified components” mean components of
x-ray systems which are subject to regulations promulgated under Public Law
90-602, the Radiation Control for Health and Safety
Act of 1968.
(z) “Certified system” means any x-ray system
which has one or more certified component(s).
(aa) “Changeable filters” mean any filter, exclusive
of inherent filtration, which can be removed from the useful beam through any
electronic, mechanical, or physical process.
(ab) “Coefficient of variation” or “C” means the
ratio of the standard deviation to the mean value of a population of
observations. It is estimated using the following equation:
where:
s = Standard
deviation of the population;
= Mean value of observations in sample;
= The ith observation in sample; and
n = Number of
observations in sample.
(ac) “Computed radiography (CR)” means a
projection x-ray imaging method in which a cassette houses a phosphor plate
rather than photographic film. This
photostimulable phosphor-coated plate captures a latent image when exposed to
x-rays and, when processed, releases light that is converted to a digital
image.
(ad) “Computed tomography (CT)” means the production
of a tomogram by the acquisition and computer processing of x-ray transmission
data.
(ae) “Computed tomography dose index (CTDI)” means
the integral from -7T to +7T of the dose profile along a line perpendicular to
the tomographic plane divided by the product of the nominal tomographic section
thickness and the number of tomograms produced in a single scan, that is:
where:
z = Position along
a line perpendicular to the tomographic plane;
D(z) = Dose at
position z;
T = Nominal
tomographic section thickness; and
n = Number of
tomograms produced in a single scan.
This definition
assumes that the dose profile is centered around z = 0 and that, for a multiple
tomogram system, the scan increment between adjacent scans is nT.
(af) “Cone beam
computed tomography (CBCT)” means a digital volume tomography method used in
some imaging applications using two dimensional digital detector arrays, and a
cone-shaped x-ray beam, instead of a fan-shaped beam, that rotates around the
patient to generate a high resolution, 3D image, with
high geometric accuracy. Reconstruction
algorithms can be used to generate images of any desired plane.
(ag) “Contact therapy system” means an x-ray
system used for therapy with the x-ray tube port placed in contact with or
within 5 centimeters of the surface being treated.
(ah) “Contrast resolution” means the ability to detect,
image and display similar tissues or materials such as gray-white matter and
liver-spleen.
(ai) “Contrast scale (CS)” means the change in the
linear attenuation coefficient per CTN relative to water, that is:
where:
μx = Linear
attenuation coefficient of the material of interest;
μw = Linear
attenuation coefficient of water;
CTNx= CTN of the
material of interest; and
CTNw= CTN of water.
(aj) “Control panel”
means that part of the x-ray control upon which are mounted the switches,
knobs, pushbuttons, and other hardware necessary for manually setting the
technique factors.
(ak) “Cooling curve”
means the graphical relationship between heat units stored and cooling time.
(al) “CT conditions of operation” means all
selectable parameters governing the operation of a CT x-ray system including,
but not limited to, nominal tomographic section thickness, filtration, and the
technique factors as defined in He-P 4041.02(cy).
(am) “CT dosimetry phantom” means the phantom used
for determination of the dose delivered by a CT x-ray system.
(an) “CT gantry” means the tube housing
assemblies, beam-limiting devices, detectors, and the supporting structures and
frames which hold these components.
(ao) “CT number
(CTN)” means the number used to represent the x-ray attenuation associated with
each elemental area of the CT image.
CTN
where:
k = A constant, a
normal value of 1,000 when the Hounsfield scale of CTN is used;
μx = Linear
attenuation coefficient of the material of interest; and
μw = Linear
attenuation coefficient of water.
(ap) “CT scan” means the complete process of
collecting x-ray transmission data for the production of
a tomogram. This includes data collected
simultaneously during a single scan for the production of
one or more tomograms.
(aq) “CT scan
increment” means the amount of relative displacement of the patient with respect
to the CT system between successive scans measured along the direction of the
displacement.
(ar) “CT scan time”
means the time between the beginning and end of the x-ray transmission data
accumulation for a CT scan.
(as) “Cumulative air kerma”
means the total air kerma accrued from the beginning
of an examination or procedure and includes all contributions from fluoroscopic
and radiographic irradiation.
(at) “Dead-man switch” means a switch so
constructed that a circuit closing contact can be maintained only by continuous
pressure on the switch by the operator.
(au) “Demonstration” means a showing of the merits
of a machine to a prospective customer.
(av) “Diagnostic imaging system” means an
assemblage of components for the generation, emission, reception,
transformation, storage and visual display of the
resultant image.
(aw) “Diagnostic source assembly” means the tube
housing assembly with a beam-limiting device attached.
(ax) “Diagnostic x-ray system” means an x-ray
system designed for irradiation of any part of the human or animal body for the
purpose of diagnosis or visualization.
(ay) “Diagnostic x-ray imaging system” means an
assemblage of components for the generation, emission and reception of x-rays
and the transformation, storage and visual display of
the resultant x-ray image.
(az) “Digital
radiography (DR)” means an x-ray imaging method or radiography which produces a
digital rather than film projection image.
The term includes both CR and DDR.
(ba) “Direct Digital
Radiography (DDR”) means an x-ray imaging method in which a digital sensor,
rather than photographic film or phosphor plate, is used to capture an x-ray
image. DDR is a cassette-less imaging
method providing faster acquisition time than cassette-based CR, using an
electronic sensor that converts x-rays to electronic signals, current or
charge, when exposed to x-rays.
(bb) “Direct scattered radiation” means that scattered
radiation which has been deviated in direction only by materials irradiated by
the useful beam.
(bc) “Dose area
product (DAP)” means the product of the air kerma and
the area of the irradiated field and is measured in Gy-cm2, so it
does not change with the distance from the x-ray tube. The term includes the term kerma-area product (KAP).
(bd) “Dose profile” means the dose as a function
of position along a line.
(be) “Elemental
area” means the smallest area within a tomogram for which the x-ray attenuation
properties of a body are depicted.
(bf) “Entrance exposure rate” means the exposure
in air per unit time at the point where the center of the useful beam enters
the patient.
(bg) “Entrance skin
exposure (ESE)” means x-ray exposure of the skin, expressed in mR or air kerma (Gy).
(bh) “Equipment”
means “x-ray equipment” as defined in He-P 4041.02(fo).
(bi) “Exposure rate” means the amount of
ionization produced or incident per unit of time.
(bj) “Field emission equipment” means equipment which uses an
x-ray tube in which electron emission from the cathode is due solely to the
action of an electric field.
(bk) “Filter” means material placed in the useful
beam to absorb preferentially selected radiations.
(bl) “Fluoroscopic
air kerma display devices” means separate devices,
subsystems or components that provide the display of AKR and cumulative air kerma. They include
radiation detectors, if any, electronic and computer components, associated
software and data displays.
(bm) “Fluoroscopic
imaging assembly” means the image receptor(s), the image intensifier, the
spot-film device, electrical interlocks, and structural material providing
linkage between the image receptor and diagnostic source assembly as a
subsystem in which x-ray photons produce a fluoroscopic image.
(bn) “Fluoroscopic
irradiation time” means the cumulative duration during an examination or
procedure of operator-applied continuous pressure to the device, enabling x-ray
tube activation in any fluoroscopic mode of operation.
(bo) “Fluoroscopic
procedure” means the production and display of serial x-ray images for the
purpose of observing real-time motion of anatomical structures.
(bp) “Fluoroscopy”
means a technique for generating x-ray images and presenting them
simultaneously and continuously as visible images.
(bq) “Focal spot”
means the actual focal spot area projected on the anode of the x-ray tube bombarded
by the electrons accelerated from the cathode and from which the useful beam
originates.
(br) “General purpose
radiographic x‑ray system” means any radiographic x-ray system which, by
design, is not limited to radiographic examination of specific anatomical
regions.
(bs) “Gonad shield” means a protective barrier for
the testes or ovaries.
(bt) “Half-value
layer (HVL)” means the thickness of specified material which attenuates the
beam of radiation to an extent such that the exposure rate is reduced to
one-half of its original value and for which the contribution of all scattered
radiation, other than any which might be present initially in the beam
concerned, is deemed to be excluded.
(bu) “Hand-held x-ray
equipment” means x-ray equipment that is designed to be hand-held during
operation.
(bv) “Healing arts screening” means the testing of human
beings using x-ray machines for the detection or evaluation of health indications
when such tests are not specifically and individually ordered by a licensed
practitioner of the healing arts legally authorized to prescribe such x-ray
tests for the purpose of diagnosis or treatment.
(bw) “Heat unit”
means a unit of energy equal to the product of the peak kilovoltage,
milliamperes, and seconds.
(bx) “Image intensifier” means a device, installed
in its housing, which instantaneously converts an x-ray pattern into a
corresponding light image of higher intensity.
(by) “Image quality” means the exactness of a
2-dimensional representation of the patient’s anatomy on the radiographic
image.
(bz) “Image receptor”
means any device, such as a fluorescent screen or radiographic film, which
transforms incident x-ray photons either into a visible image or into another
form which can be made into a visible image by further transformations.
(ca) “Image receptor support” means, for
mammographic systems, that part of the system designed to support the image
receptor in a horizontal plane during mammography.
(cb) “Inherent filtration” means the filtration of the
useful beam provided by the permanently installed components of the tube
housing assembly.
(cc)
“Interventional procedures” means procedures that utilize imaging for
guidance. Imaging includes, but is not
limited to, fluoroscopy and CT scan.
(cd) “Irradiation” means the exposure of matter to
ionizing radiation.
(ce) “Isocenter”
means the center of the smallest sphere through which the beam axis passes when
the equipment moves through a full range of rotations about a common center.
(cf) “Kerma” means
the quantity as defined by the International Commission on Radiation Units and
Measurements. The kerma,
K, is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies
of the all charged particles liberated by the
uncharged particles in mass dm of material; thus K=dEtr/dm
in units of J/kg, where the special name for the unit of kerma
is gray (Gy).
When the material is air, the quantity is referred to as “air kerma.”
(cg) “Kilovolts peak (kVp)”
means “peak tube potential” as defined in He-P 4041.02(de).
(ch) “kV” means
kilovolts, which is 1,000 volts.
(ci) “kWs” means
kilowatt-second which is equivalent to 103 watt-second where 1
watt-second = kV × mA × second.
(cj) “Last image hold
(LIH) radiograph” means an image obtained either by retaining one or more
fluoroscopic images, which can be temporarily integrated, at the end of a
fluoroscopic exposure or by initiating a separate and distinct radiographic
exposure automatically and immediately in conjunction with termination of the
fluoroscopic exposure.
(ck) “Lateral
fluoroscope” means the x-ray tube and image receptor combination in a biplane
system dedicated to the lateral projection.
It consists of the lateral x-ray tube housing assembly and the lateral
image receptor that are fixed in position relative to the table with the x-ray
beam axis parallel to the plane of the table.
(cl) “Lead equivalent” means the thickness of lead
affording the same attenuation, under specified conditions, as the material in
question.
(cm) “Leakage
radiation” means radiation emanating from the diagnostic or therapeutic source
assembly other than the useful beam and radiation produced when the exposure
switch or timer is not activated.
(cn) “Leakage technique factors” means the technique factors
associated with the diagnostic or therapeutic x-ray source assembly which are
used in measuring leakage and are defined as follows:
(1) For diagnostic source assemblies intended for
capacitor energy storage equipment, the maximum-rated peak tube potential and
the maximum-rated number of exposures in a hour for
operation at the maximum-rated peak tube potential with the quantity of charge
per exposure being 10 millicoulombs;
(2) For diagnostic source assemblies intended for
field emission equipment rated for pulsed operation, the maximum-rated peak
tube potential and the maximum-rated number of x-ray
pulses in an hour for operation at the maximum-rated peak tube potential; or
(3) For all other diagnostic source assemblies,
the maximum-rated peak tube potential and the
maximum-rated continuous tube current for the maximum-rated peak tube
potential.
(co) “Lease” means a machine that is possessed and
used for a specified term in exchange for consideration. The term includes “rental.”
(cp) “Light field” means that area of the
intersection of the light beam from the beam-limiting device and one of the set
of planes parallel to and including the plane of the image receptor, whose
perimeter is the locus of points at which the illumination is one-fourth of the
maximum in the intersection.
(cq) “Line-voltage
regulation” means the difference between the no-load and the load line
potentials expressed as a percent of the load line potential calculated using
the following equation:
Percent
line-voltage regulation =
where:
VN =
No-load line potential; and
VL =
Load line potential.
(cr) “Loaner” means a
machine that is a replacement for a registered machine that is being repaired,
calibrated or both. A loaner shall not include
a machine that is purchased as a replacement for a registered machine.
(cs) “mA” means milliampere, which is 1/1,000 of
an ampere.
(ct) “Magnetic
resonance imaging scanner” means a diagnostic tool using a combination of
magnetic fields and radio frequency waves to create cross-sectional images of
the body.
(cu) “Magnetic resonance imaging (MRI)” means a
non-invasive diagnostic procedure used to create cross-sectional images of the
body by use of magnetic fields and radio frequency fields.
(cv) “Mammo-tomo” means
breast tomosynthesis in which the x-ray tube moves in an arch during the
exposure. The term includes “three dimensional breast imaging.”
(cw) “mAs” means milliampere second, which is 1/1,000 of an
ampere second.
(cx) “Maximum line
current” means the root-mean-square current in the supply line of an x-ray
machine operating at its maximum rating.
(cy) “Micro computed
tomography” (Micro CT) means a scanning method
that uses x-rays to create cross-sections of a physical object that can be used
to recreate a virtual, 3-dimensional model.
The pixel sizes of the cross-sections generated with this method are in
the micrometer range.
The term includes “high-resolution x-ray tomography.”
(cz) “Mobile MRI
unit” means a magnetic resonance imaging scanner that is approved by the
federal Food and Drug Administration for the provision of diagnostic MRI
services and which is physically located in a vehicle such as a self-contained
van or tractor trailer for the purpose of transporting the magnetic resonance
imaging scanner from one site to another.
(da) “Mobile x-ray
equipment” means x-ray equipment mounted on a permanent base with wheels and/or
casters for moving while completely assembled.
(db) “Multiple
tomogram system” means a computed tomography x-ray system which obtains x-ray
transmission data simultaneously during a single scan to produce more than one
tomogram.
(dc) “Noise” means the standard deviation of the
fluctuations in CTN expressed as a percentage of the attenuation coefficient of
water and is calculated using the following equation:
where:
CS= Contrast scale
as defined in He-P 4041.02(t);
μw = Linear
attenuation coefficient of water; and
s = Standard deviation
of the CTN of picture elements in a specified area of the CT image.
(dd) “Nominal tomographic section thickness” means
the full width at half-maximum of the sensitivity profile taken at the center
of the cross-sectional volume over which x-ray transmission data are collected.
(de) “O-Arm” means a mobile fluoroscope, operated
as a C-arm fluoroscope, which is opened and positioned over the area of
interest on the patient being examined then closed around the patient to
facilitate 360-degree x-ray imaging.
(df) “Patient” means
an individual or animal subjected to healing arts examination, diagnosis, or
treatment.
(dg) “Peak tube potential” means the maximum value
of the potential difference across the x-ray tube during an exposure.
(dh) “Phantom” means a volume of material with an
atomic number (Z) and density similar to biological
tissue, which behaves in a manner similar to tissue with respect to the
attenuation and scattering of radiation.
(di) “Physician assistant” means a person licensed
as a physician assistant by the New Hampshire board of medicine.
(dj) “Phototimer” means a method for controlling radiation exposure
to image receptors by the amount of radiation which reaches a radiation
monitoring device(s) that is part of an electronic circuit which controls the
duration of time the tube is activated.
(dk) “Picture element” means an elemental area of
a tomogram.
(dl) “Portable x-ray equipment” means x-ray
equipment designed to be hand carried.
(dm) “Position indicating device (PID)” means a
device on dental x-ray equipment used to indicate the beam position and to
establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a
beam-limiting device.
(dn) “Positive beam
limitation (PBL)” means the automatic or semi-automatic adjustment of an x-ray
beam to the size of the selected image receptor, whereby exposures cannot be
made without such adjustment.
(do) “Primary protective barrier” means the
material, excluding filters, placed in the useful beam, for protection
purposes, to reduce the radiation exposure.
(dp) “Protective apron”
means an apron made of radiation absorbing materials used to reduce radiation
exposure.
(dq) “Protective
barrier” means a barrier of radiation absorbing material(s) used to reduce
radiation exposure.
(dr) “Protective
glove” means a glove of radiation absorbing materials used to reduce radiation
exposure.
(ds) “Pulsed mode” means operation of the x-ray
system such that the x-ray tube current is pulsed by the x-ray control to
produce one or more exposure intervals of duration less than one-half second.
(dt) “Quality assurance” means a program providing
for verification by written procedures such as testing, auditing, and
inspection to ensure that deficiencies, deviations, defective equipment, or
unsafe practices, or a combination thereof, relating to the use, disposal, management or manufacture of radiation devices are
identified, promptly corrected and reported to the appropriate regulatory
authorities.
(du) “Qualified expert” means an individual who
has demonstrated to the satisfaction of DHHS/RHS that such individual possesses
the knowledge, skills and training to measure ionizing
radiation to evaluate radiation parameters, to evaluate safety techniques and
to advise regarding radiation protection needs as described in He-P 4040.
(dv) “Radiation detector” means a device which in
the presence of radiation provides a signal or other indication suitable for
use in measuring one or more quantities of incident radiation.
(dw) “Radiation therapy
simulation system” means a radiographic or fluoroscopic x-ray system intended
for localizing the volume to be exposed during radiation therapy and confirming
the position and size of the therapeutic irradiation field.
(dx) “Radiograph” means an image receptor on which
the image is created directly or indirectly by an x-ray pattern and results in
a permanent record.
(dy) “Radiographic
imaging system” means any system whereby a permanent or semi-permanent image is
recorded on an image receptor by the action of ionizing radiation.
(dz) “Rated line
voltage” means the range of potentials, in volts, of the supply line specified
by the manufacturer at which the x-ray machine is designed to operate.
(ea) “Rated output current”
means the maximum allowable load current of the x-ray high-voltage generator.
(eb) “Rating” means
the operating limits as specified by the component manufacturer.
(ec) “Recording” means
producing a permanent form of an image resulting from x-ray photons.
(ef) “Reference
plane” means a plane which is displaced from and parallel to the tomographic
plane.
(eg) “Resolution”
means the ability to image two separate objects and visually distinguish one
from the other.
(eh) “Response time” means the time required for
an instrument system to reach 90 percent of its final reading when the
radiation‑sensitive volume of the instrument system is exposed to a step
change in radiation flux from zero sufficient to provide a steady state
mid-scale reading.
(ei) “Scan” means the
complete process of collecting x-ray transmission data for
the production of a tomogram which may be collected simultaneously
during a single scan for the production of one or more tomograms.
(ej) “Scan increment”
means the amount of relative displacement of the patient with respect to the CT
x-ray system between successive scans measured along the direction of such
displacement.
(ek) “Scan sequence” means a pre-selected set of
two or more scans performed consecutively under pre-selected CT conditions of
operation.
(el) “Scan time”
means the period of time between the beginning and end
of x-ray transmission data accumulation for a single scan.
(em) “Scattered
radiation” means radiation that, during passage through matter, has been
deviated in direction.
(en) “Secondary dose
monitoring system” means a system that will terminate irradiation in the event
of a failure of the primary system.
(eo) “Secondary
protective barrier” means a barrier sufficient to attenuate the stray radiation
to the required degree.
(ep) “Security screening system” means a
non-medical use screening system designed for the detection of contraband and
weapons concealed on a person or in a vehicle while being occupied by one or
more people.
(eq) “Security screening system” means a
non-medical use screening system designed for the detection of contraband and
weapons concealed on a person or in a vehicle while being occupied by one or
more people.
(er) “Shutter” means a device attached to the tube
housing assembly which can intercept the entire cross-sectional area of the
useful beam and which has a lead equivalency not less than that of the tube
housing assembly.
(es) “Single tomogram system” means a CT x-ray
system which obtains x-ray transmission data during a scan to produce a single
tomogram.
(et) “Spatial frequency” means a measure of the
changes in tissue attenuation characteristics. Abrupt changes have high spatial
frequency (e.g., bone-lung interface), and gradual changes (e.g., liver-spleen
interface) have low spatial frequency. Spatial frequency is expressed as line
pair per millimeter (lp/mm).
(eu) “Spatial resolution”
means the ability to image anatomical structures or small objects that have
high subject contrast, such as bone versus soft tissue.
(ev) “Solid state
x-ray imaging device” means an assembly, typically in a rectangular panel
configuration, that intercepts x-ray photons and converts the photon energy
into a modulated electronic signature representative of the x-ray intensity
over the area of the imaging device. The
electronic signal is then used to create an image for display, storage or both.
(ew) “Source” means
the focal spot of the x-ray tube.
(ex) “Source-image receptor distance (SID)” means
the distance from the source to the center of the input surface of the image
receptor.
(ey) “Source-skin
distance (SSD)” means the distance from the source to the center of the entrant
x-ray field in the plane tangent to the patient skin surface.
(ez) “Spot check”
means an abbreviated calibration procedure which is performed to assure that a
previous calibration continues to be valid.
(fa) “Spot film” means a radiograph which is made
during a fluoroscopic examination to permanently record conditions which exist
during that fluoroscopic procedure.
(fb) “Spot-film device” means a device intended to
transport and/or position a radiographic image receptor between the x-ray
source and fluoroscopic image receptor and includes a device intended to hold a
cassette over the input end of an image intensifier for the purpose of making a
radiograph.
(fc) “Stationary x-ray equipment” means x-ray
equipment which is installed in a fixed location.
(fd) “Stray
radiation” means the sum of leakage and scattered radiation.
(fe) “Supervising
physician” means a physician who holds a current license issued by the New
Hampshire board of medicine and who supervises all professional activities of a
physician assistant.
(ff) “Technique factors” means the following
conditions of operation:
(1) For capacitor energy storage equipment, peak
tube potential in kV and quantity of charge in mAs;
(2) For field emission equipment rated for pulsed
operation, peak tube potential in kV, and number of x-ray pulses;
(3) For CT x-ray systems designed for pulsed operation,
peak tube potential in kV, scan time in seconds, and either tube current in mA,
x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the
product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;
(4) For CT x-ray systems not designed for pulsed
operation, peak tube potential in kV, and either tube current in mA and scan
time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time
are equivalent; and
(5) For all other equipment, peak tube potential
in kV, and either tube current in mA and exposure time in seconds, or the
product of tube current and exposure time in mAs.
(fg) “Tenth-value
layer (TVL)” means the thickness of a specified material which attenuates
x-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced
to one-tenth of the value measured without the material at the same point.
(fh) “Termination of
irradiation” means the stopping of irradiation in a fashion which will not
permit continuance of irradiation without the resetting of operating conditions
at the control panel.
(fi) “Transmission system” means a security
screening system using the conventional means of radiographic imaging in which
x-rays pass through a target, such as a person or object and create
shadow-grams of enclosed objects, such as contraband, based on their radiation
attenuating properties.
(fj) “Tomogram” means the depiction of the x-ray
attenuation properties of a section through the body.
(fk) “Tomographic
plane” means that geometric plane which is identified as corresponding to the
output tomogram.
(fl) “Tomographic section”
means the volume of an object whose x-ray attenuation properties are imaged.
(fm) “Tube” means an
x‑ray tube, unless otherwise specified.
(fn) “Tube housing
assembly” means the tube housing with tube installed to include the
high-voltage and/or filament transformers and other appropriate elements when
such are contained within the tube housing.
(fo) “Tube rating
chart” means the set of curves which specify the rated limits of operation of
the tube in terms of the technique factors.
(fp) “Useful beam”
means the radiation emanating from the tube housing port or the radiation head
and passing through the aperture of the beam limiting device when the exposure
controls are in a mode to cause the system to produce radiation.
(fq)
“Variable-aperture beam-limiting device” means a beam-limiting device
which has capacity for stepless adjustment of the x-ray field size at a given
SID.
(fr) “Visible area”
means that portion of the input surface of the image receptor over which
incident x-ray photons are producing a visible image.
(fs) “Wedge filter” means an added filter
effecting continuous progressive attenuation on all or part of the useful beam.
(ft) “X-ray diffraction (XRD)” means the analysis of
the characteristic atomic pattern of x-rays scattered when the primary beam
from the machine strikes the sample.
(fu) “X-ray exposure control” means a device,
switch, button or other similar means by which an operator
initiates and/or terminates the radiation exposure and may include such
associated equipment as timers and back-up timers.
(fv) “X-ray
equipment” means an x-ray system, subsystem, or component thereof.
(fw)
“X-ray field” means that area of the intersection of the useful beam and
any one of the set of planes parallel to and including the plane of the image
receptor, whose perimeter is the locus of points at which the exposure rate is
one-fourth of the maximum in the intersection.
(fx)
“X-ray fluorescence (XRF)” means the analysis of the characteristic
x-rays created when the primary beam from the machine strikes the sample.
(fy)
“X-ray high-voltage generator” means a device which transforms
electrical energy from the potential supplied by the x-ray control to the tube
operating potential and may include a means for transforming alternating
current to direct current, filament transformers for the x-ray tube(s),
high-voltage switches, electrical protective devices, and other appropriate
elements.
(fz)
“X-ray reciprocity” means any business entity proposing to bring a
radiation machine into this state from another state for operation only by the business
entity, except in areas of exclusive federal jurisdiction, for a period not in excess of 180 days in any calendar year.
(ga) “X-ray subsystem” means any
combination of two or more components of an x-ray system for which there are
requirements specified in this section.
(gb) “X-ray system”
means an assemblage of components for the controlled production of x-rays and
includes as a minimum an x-ray high-voltage generator, an x-ray control, a tube
housing assembly, a beam‑limiting device, and the necessary supporting
structures and may include additional components which function with the system
which are considered integral parts of the system.
(gc) “X-ray table”
means a patient support device with its patient support structure or tabletop
interposed between the patient and the image receptor during radiography or
fluoroscopy and may include any stretcher equipped with a radiolucent panel or
any table equipped with a cassette tray (bucky), cassette tunnel, image
intensifier, or spot-film device beneath the tabletop.
(gd) “X-ray tube”
means any electron tube which is designed to be used primarily for the production of x-rays.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10806, eff 3-28-15;
paras (n), (o), (eo) and (fh)
amd by #12024, INTERIM, eff 10-28-16, EXPIRED:
4-26-17; paras (n), (o), (eo) and (fh) amd by #12215, eff 6-20-17
PART He-P 4042 -
RESERVED
PART
He-P 4043 RADIATION SAFETY REQUIREMENTS FOR
ANALYTICAL X-RAY EQUIPMENT
He-P 4043.01 Purpose. This part provides special requirements for
analytical x-ray equipment.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4043.02 Scope.
The requirements of this part are in addition to, and not in
substitution for, requirements in other parts of these rules.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4043.03 Definitions.
(a) “Analytical x-ray equipment” means equipment used for
x-ray diffraction or fluorescence analysis.
(b) “Analytical
x-ray system” means a group of components utilizing x-rays to determine the
elemental composition or to examine the microstructure of materials.
(c) “Fail-safe characteristics” mean a design
feature which causes beam port shutters to close, or otherwise prevents
emergence of the primary beam, upon the failure of a safety or warning device.
(d) “Fixed gauge” means devices that are
installed by design to monitor/measure the level of the contents of vessels or
tanks.
(e) “Hybrid gauge” means a gauging device
utilizing both x-ray and radioactive material sources.
(f) “Local components” mean part of an analytical
x-ray system and include areas that are struck by x-rays such as radiation
source housings, port and shutter assemblies, collimators, sample holders,
cameras, goniometers, detectors, and shielding, but do not include power
supplies, transformers, amplifiers, readout devices, and control panels.
(g) “Normal operating procedures” mean
step-by-step instructions necessary to accomplish the analysis. These procedures shall include sample
insertion and manipulation, device alignment, routine maintenance by the
registrant or licensee, and data recording procedures, which are related to
radiation safety.
(h) “Open-beam configuration” means an analytical
x-ray system in which an individual could accidentally place some part of his
body in the primary beam path during normal operation.
(i) “Primary beam”
means ionizing radiation which passes through an aperture of the source housing
by a direct path from the x-ray tube or a radioactive source located in the
radiation source housing.
(j) “Safety device” means a device which prevents
the entry of any portion of an individual’s body into the primary x-ray beam
path or which causes the beam to be shut off upon entry into its path.
(k) “Scanning Electron Microscope (SEM)” means
electronic equipment that produces radiation incidental to its operation and
which is not exempt from registration under the provision of He-P 4040.05(a). The term includes “transmission electron
microscope.”
(l) “X-ray gauge” means a radiation generating
device designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density level or interface
location.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4043.04 Equipment Requirements.
(a) All open-beam configurations shall be provided
with a safety device which prevents the entry of any portion of an individual’s
body into the primary x-ray beam path or which causes the beam to be shut off
upon entry into its path.
(b) DHHS/RHS may grant an exemption from the
requirement of a safety device for open-beam configurations if the registrant submits an application requesting such exemptions, and:
(1) A description of the various safety devices
that have been evaluated;
(2) The reason each of these devices cannot be
used;
(3) A description of the alternative methods that
will be employed to minimize the possibility of an accidental exposure; and
(4) The procedures followed to assure that
operators and others in the area will be informed of the absence of safety
devices.
(c) All open-beam configurations shall contain a
warning device.
(d) The warning device required in He-P
4043.04(c) shall:
(1) Indicate the x-ray tube “on-off” status and
be located near the radiation source housing, if the primary beam is controlled
in this manner; or
(2) Indicate the shutter “open-closed” status and
be located near each port on the radiation source housing, if
the primary beam is controlled in this manner.
(e)
Each analytical x-ray machine shall have an easily visible warning light
labeled with the words “X-RAY ON” located near any switch that energizes an
x-ray tube.
(f) The warning light required in He-P 4043.04(e)
shall be illuminated only when the x-ray tube is energized.
(g) For a radioactive source contained in an
analytical device, a warning light shall be located near any switch that opens
a housing shutter.
(h) The warning light required in He-P
4043.04(e), (f) and (g) shall be illuminated only when the shutter is open.
(i) Warning devices
shall be labeled so that their purpose is easily identified.
(j) Warning devices shall have fail-safe
characteristics.
(k) Any unused port on a radiation machine source
housing shall be secured in the closed position in such a manner as to prevent
casual opening.
(l) All analytical x-ray equipment shall be labeled
with a readily discernable sign(s) bearing the radiation symbol and the words:
(1) “CAUTION - HIGH INTENSITY X-RAY BEAM” on the
x-ray source housing on one sign, and “CAUTION RADIATION - THIS EQUIPMENT
PRODUCES RADIATION WHEN ENERGIZED” near any switch that energizes an x-ray tube
if the radiation source is an x-ray tube on another sign; or
(2) “CAUTION - RADIOACTIVE MATERIAL” on the
source housing in accordance with He-P 4020.07, if the
radiation source is a radionuclide.
(m) All open-beam configurations shall be
equipped with a shutter at each port on the radiation
source housing so the shutter cannot be opened unless a collimator or a
coupling has been connected to the port.
(n) Each radiation machine source housing shall
be equipped with an interlock that shuts off the tube if the tube is removed
from the radiation source housing or if the housing is disassembled.
(o) Each radioactive source housing or port cover
or each x-ray tube housing shall be so constructed that, with all shutters
closed, the radiation measured at a distance of 5
centimeters from the source housing or for x-ray tubes at any specified tube
rating is not capable of producing a dose in excess of 2.5 millirems (0.025
mSv) in one hour.
(p) Each x-ray generator shall be supplied with a
protective cabinet which limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is
not capable of producing a dose in excess of 0.25 millirem (2.5 μSv) in one hour.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4043.05 Area Requirements.
(a) The local components of an analytical x-ray system
shall be located and arranged and include sufficient shielding or access
control such that no radiation levels exist in any area surrounding the local
component group which result in a dose to an individual present therein in excess of the dose limits given in He-P 4020.
(b) For systems utilizing x-ray tubes, the
requirements specified in He-P 4043.05(a) shall be met at any specified tube
rating.
(c) Radiation surveys, as required by He-P
4022.01, of all analytical x-ray systems sufficient to show compliance with
He-P 4043.05(a) shall be performed:
(1) Upon installation of the equipment, and at
least once every 12 months thereafter;
(2) Following any change in the initial
arrangement, number, or type of local components in the system;
(3) Following any maintenance requiring the
disassembly or removal of a local component in the system;
(4) During the performance of maintenance and
alignment procedures if the procedures require the presence of a primary x-ray
beam when any local component in the system is disassembled or removed;
(5) Any time a visual inspection of the local
components in the system reveals an abnormal condition; and
(6) Whenever personnel monitoring devices show a
significant increase over the previous monitoring period or the readings are
approaching the limits specified in He-P 4020.05.
(d) Radiation survey measurements shall not be required
if a registrant or licensee can demonstrate compliance with He-P 4043.05(a) to
the satisfaction of DHHS/RHS.
(e) Each area or room containing analytical x-ray
equipment shall be conspicuously posted with a sign or signs bearing the
radiation symbol and the words “CAUTION - X-RAY EQUIPMENT” in accordance with
He-P 4022.11.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4043.06 Operating Requirements.
(a) Normal and emergency operating procedures
shall be written and available to all analytical x-ray equipment workers.
(b) These procedures shall include:
(1) Sample insertion and manipulation;
(2) Equipment alignment;
(3) Routine maintenance procedures to be
performed by the registrant; and
(4) Data recording procedures, which are related
to radiation safety.
(c) No individual shall be permitted to operate
analytical x-ray equipment in any manner other than that specified in the
procedures unless such individual has obtained written approval of the
radiation safety officer.
(d) No individual shall bypass a safety device or
interlock unless such individual has obtained written approval of the radiation
safety officer.
(e) The written approval required in He-P
4043.06(c) and (d) shall be for a specified period of time.
(f) When a safety device or interlock has been
bypassed, a sign bearing the words “SAFETY DEVICE NOT WORKING” shall be placed
on the radiation source housing.
(g) Except as specified in He-P 4043.06(c), (d),
(e), and (f), no operation involving removal of covers, shielding materials, or
tube housings or modifications to shutters, collimators, or beam stops shall be
performed without ascertaining that the tube is off and will remain off until
safe conditions have been restored.
(h) The main switch, rather than interlocks,
shall be used for routine shutdown in preparation for repair as specified in
He-P 4043.06(g).
(i)
Radioactive
source housings shall be opened for source replacement, leak testing, or other maintenance
or repair procedures only by individuals authorized to specifically conduct
such procedures under a license issued by DHHS/RHS, the U.S. Nuclear Regulatory
Commission (NRC), an Agreement State, or a Licensing State.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4043.07 Personnel Requirements.
(a) No individual shall be permitted to operate
or maintain analytical x-ray equipment unless such individual has received
instruction and demonstrated competence as to:
(1) Identification of radiation hazards
associated with the use of the equipment;
(2) The significance of the various radiation
warning devices, safety devices, and interlocks incorporated into the
equipment, or the reasons such devices have not been installed on certain
equipment;
(3) Any extra precautions required relevant to
the use of the equipment;
(4) Proper operating procedures for the
equipment;
(5) Recognition of symptoms of an acute localized
exposure; and
(6) Proper procedures for reporting an actual or
suspected exposure.
(b) Any individual using analytical x-ray
equipment having an open-beam configuration and not equipped with a safety
device shall be provided with finger or wrist dosimetric
devices.
(c) Personnel maintaining analytical x-ray
equipment shall be provided with finger or wrist dosimetric
devices if the maintenance procedures require the presence of a primary x-ray
beam when any local component in the analytical x-ray system is disassembled or
removed.
(d) Reported dose values shall not be used for
the purpose of determining compliance with He-P 4020.05 unless evaluated by a
qualified expert.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
PART He-P 4044
RADIATION REQUIREMENTS FOR PARTICLE ACCELERATORS
He-P 4044.01 Purpose. He-P 4044 establishes requirements for the
registration and the use of particle accelerators.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.02 Scope.
In addition to the requirements of He-P 4044:
(a) All registrants are subject to the
requirements of He-P 4001, He-P 4003, He-P 4019 through He-P 4022, and He-P
4040;
(b) Registrants engaged in industrial
radiographic operations are subject to the requirements of He-P 4034;
(c) Registrants engaged in the healing arts are
subject to the requirements of He-P 4041, He-P 4035, and He-P 4045 through He-P
4047; and
(d) Registrants whose operations result in the
production of radioactive material are subject to the requirements of He-P
4030.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.03 Registration Requirements. No person shall receive, possess, use,
transfer, own, or acquire a particle accelerator except as authorized in a
registration issued pursuant to He-P 4044 and the general procedures for
registration of particle accelerator facilities included in He-P 4040.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.04 General Requirements for the Issuance of a
Registration for Particle Accelerators.
In addition to the requirements of He-P 4040, a registration application
for use of a particle accelerator shall be approved if DHHS/RHS determines
that:
(a) The applicant is qualified by reason of
training and experience to use the accelerator for the purpose requested in
accordance with He-P 4044 and He-P 4019 through He-P 4022 in such a manner as
to minimize danger to public health and safety or property;
(b) The applicant’s proposed or existing
equipment, facilities, operating and emergency
procedures are adequate to protect health and minimize danger to public health
and safety or property;
(c) The issuance of the registration will not be
inimical to the health and safety of the public;
(d) The applicant satisfies any applicable
special requirement in section He-P 4044.05;
(e) The applicant has appointed a radiation
safety officer;
(f) The applicant and
the applicant’s staff have substantial experience in the use of particle
accelerators and training sufficient for application for the intended uses;
(g) The applicant has established a radiation
safety committee to approve, in advance, proposals for uses of particle
accelerators, whenever deemed necessary by DHHS/RHS; and
(h) The applicant has an adequate training
program for particle accelerator operators.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.05 Human Use of Particle Accelerators. In addition to the requirements set forth in
He-P 4040, a registration for use of a particle accelerator in the healing arts
may be issued if:
(a) The applicant has appointed a medical
committee of at least 3 members to evaluate all proposals for research,
diagnostic, and therapeutic use of a particle accelerator. Membership of the committee shall include
physicians expert in internal medicine, hematology, therapeutic radiology, and
a person experienced in depth dose calculations and protection against
radiation;
(b) The individuals designated on the application
as the users have substantial training and experience in deep therapy
techniques or in the use of particle accelerators to treat humans; and
(c) The individual designated on the application
as the user is a physician.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06,
EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.06 Limitations.
(a) No registrant shall permit any person to act
as a particle accelerator operator until such person:
(1) Has been instructed in radiation safety and
demonstrates an understanding thereof;
(2) Has received copies of He-P 4019 through He-P
4022, and He-P 4044, and the registrant’s operating and emergency procedures,
and has demonstrated understanding thereof; and
(3) Has demonstrated competence to use the
particle accelerator, related equipment, and survey instruments which will be
employed.
(b) Either the radiation safety committee or the
radiation safety officer shall have the authority to terminate the operations
at a particle accelerator facility if such action is deemed necessary to
protect health and minimize danger to public health and safety or property.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.07 Shielding and Safety Design Requirements.
(a) A qualified expert, registered with DHHS/RHS,
pursuant to He-P 4040.06, shall be consulted in the design of a particle accelerator
installation and called upon to perform a radiation survey when the accelerator
is first capable of producing radiation.
(b) Each particle accelerator installation shall
be provided with such primary and secondary barriers as are as necessary to
assure compliance with He-P 4020.05 and He-P 4020.13.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.08 Particle Accelerator Controls and
Interlock Systems.
(a) Instrumentation readouts and controls on the
particle accelerator control console shall be clearly identified and easily
discernible.
(b) Each entrance into a target room or other
high radiation area shall be provided with a safety interlock that shuts down
the machine under conditions of barrier penetration.
(c) When an interlock system has been tripped, it
shall only be possible to resume operation of the accelerator by manually
resetting controls at the position where the interlock has been tripped, and
lastly at the main control console.
(d) Each safety interlock shall be on a circuit
which shall allow its operation independently of all other safety interlocks.
(e) All safety interlocks shall be designed so
that any defect or component failure in the safety interlock system prevents
operation of the accelerator.
(f) A scram button or other emergency power
cutoff switch shall be located and easily identifiable in all high radiation
areas. Such a cutoff switch shall include a manual reset so that the
accelerator cannot be restarted from the accelerator control console without
resetting the cutoff switch.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.09 Warning Devices.
(a) Each location designated as high radiation
area, and each entrance to such location shall be equipped with easily
observable flashing or rotating warning lights that operate when, and only
when, radiation is being produced.
(b) Except in facilities designed for human
exposure, each high radiation area shall have an audible warning device which
shall be activated for 15 seconds prior to the possible creation of such high
radiation area. Such warning device
shall be clearly discernible in all high radiation areas.
(c) Barriers, temporary or otherwise, and
pathways leading to high radiation areas shall be identified in accordance with
He-P 4022.04 and He-P 4022.12(b).
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.10 Operating Procedures.
(a) Particle accelerators, when not in operation,
shall be secured to prevent unauthorized use.
(b) The safety interlock system shall not be used
to turn off the accelerator beam except in an emergency.
(c) All safety and warning devices, including
interlocks, shall be checked for proper operation at intervals not to exceed 3
months. Results of such tests shall be maintained at the accelerator facility
for inspection by DHHS/RHS.
(d) Electrical circuit diagrams of the accelerator,
and the associated safety interlock systems, shall be kept current and
maintained for inspection by DHHS/RHS and available to the operator at each
accelerator facility.
(e) If, for any reason, it is necessary to
intentionally bypass a safety interlock or interlocks, such action shall be:
(1) Authorized by the radiation safety committee
and the radiation safety officer after having notified the radiation safety
committee of such action;
(2) Recorded in a permanent log and a notice
posted at the accelerator control console; and
(3) Terminated as soon as possible.
(f) A copy of the current operating and the
emergency procedures shall be maintained at the accelerator control panel.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
He-P 4044.11 Radiation Monitoring Requirements. Each particle accelerator facility shall have
available:
(a) Appropriate portable monitoring equipment
which:
(1) Is operable;
(2) Has been calibrated for the appropriate
radiations being produced at the facility;
(3) Has been tested daily for proper operation;
(4) Has been calibrated at intervals not to
exceed one year;
(5) Has been calibrated after each servicing; and
(6) Has been calibrated after repair;
(b) A radiation protection survey, performed and
documented by a qualified expert specifically registered with DHHS/RHS pursuant
to He-P 4040.06, which documents changes in shielding, operation, equipment, or
occupancy of adjacent areas;
(c) Continuous monitoring devices for all high
radiation areas which are electrically independent of the accelerator control
and safety interlock systems and are capable of providing
a readout at the control panel;
(d) An area monitor which has been calibrated at
intervals not to exceed one year and after each servicing and repair;
(e) Periodic surveys to determine the amount of
airborne particulate radioactivity present in areas of airborne hazards if
applicable;
(f) Periodic smear surveys to determine the
degree of contamination in target and other pertinent areas if applicable;
(g) An area survey which is made in accordance
with the written procedures established by a qualified expert, or the radiation
safety officer of the particle accelerator facility; and
(h) Records of:
(1) Radiation protection surveys;
(2) Calibration results;
(3) Instrumentation tests; and
(4) Smear results.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15;
ss by #10804, eff 3-26-15
He-P 4044.12 Ventilation Systems.
(a) Adequate ventilation shall be provided in areas
where airborne radioactivity may be produced.
(b) A registrant, as required by He-P 4020.14,
shall not vent, release, or otherwise discharge airborne radioactive material
to an unrestricted area in excess of the limits
specified in He-P 4090 - Table 4090.1, except as authorized pursuant to He-P
4020.14(c) or He-P 4023.02.
(c) Every reasonable effort shall be made to
maintain releases of radioactive material to unrestricted areas, as far below
the limits required in He-P 4044.12(b) as practicable.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15
PART He-P 4045
USE OF RADIATION MACHINES: ADMINISTRATIVE REQUIREMENTS
He-P 4045.01 Purpose. He-P 4045 establishes the administrative and
operational requirements for users of radiation or MRI machines in the healing
arts, veterinary medicine, and all non-medical security screening systems
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15; ss by #12024, INTERIM,
eff 10-28-16, EXPIRED: 4-26-17
New. #12215, eff 6-20-17
He-P 4045.02 General Requirements.
(a) The registrant shall assure that the
requirements of He-P 4040 are met prior to the use of any radiation or MRI
machine.
(b) The registrant shall be responsible for directing
the operation of the radiation or MRI machine(s) under the registrant’s
administrative control.
(c) The registrant or the registrant’s agent
shall assure that the requirements of He-P 4045, in addition to all other
applicable parts, are met in the operation of the radiation or MRI machine(s).
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-0707; ss by #10763, INTERIM,
eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4045.03 Administrative Controls.
(a) A radiation or MRI machine which does not
meet the provisions of these rules shall not be operated for diagnostic or
therapeutic purposes.
(b) Persons who operate radiation or MRI machines
shall be instructed in the manufacturer’s safe operating procedures and be
competent in the safe use of the equipment.
(c) All MRI machine operators shall be able to
demonstrate competence in the operation of the machine as required by (b)
above, including, at a minimum, competence in the following areas:
(1) Familiarity with equipment to include:
a. Identification of controls; and
b. Function of each control; and
(2) Emergency procedures including procedure
termination.
(d) All diagnostic radiation machine operators shall
be able to demonstrate competence in the operation of the machine as required
by (b) above, including, at a minimum competence in the following areas:
(1) Familiarity with equipment to include:
a. Identification of controls;
b. Function of each control; and
c. Use of a technique chart;
(2) Radiation protection measures to include:
a. Collimation;
b. Filtration;
c. Lead equivalent material patient protection
devices, if used;
d. Restriction of x-ray tube radiation to the
image receptor;
e. Personnel protection; and
f. Grids;
(3) Film and film processing to include:
a. Film speed as related to patient exposure;
b. Film processing parameters; and
c. Quality assurance techniques;
(4) Emergency procedures to include termination
of exposure in the event of automatic timing device failure;
(5) Proper use of personnel dosimetry;
(6) An understanding of the units of radiation
and dose; and
(7) An understanding of these rules.
(e) Specific technique factors and protocols for
any diagnostic radiation machine which cannot be programmed to select body
part, projection, or patient size, shall be created to include protocols to
identify the following:
(1) Patient’s body part and anatomical size, or
body part thickness, or age for pediatric, versus technique factors to be
utilized;
(2) Type and size of the image receptor;
(3) Type of grid, if any;
(4) Source to image receptor distance to be used,
except in dental intraoral radiography;
(5) Type and location of placement of patient
shielding used; and
(6) Technique factors kVp,
mA, and time.
(f) The registrant of a facility shall:
(1) Establish written safety procedures for the
safe operation of radiation or MRI machines;
(2) Make written safety procedures available to
all operators of radiation or MRI machines;
(3) Write safety procedures for use of machines
at the facility which shall include, but not be limited to:
a. Patient holding; and
b. Any restrictions in the operating techniques required for the safe
operation of a particular system.
(g) The radiation or MRI machine operator shall
be able to demonstrate familiarity with the written safety procedures required
in (f) above.
(h) Only staff, other persons required to be in
attendance, and patients who cannot be evacuated shall be in the room during
the radiographic exposure.
(i) All persons in
the room other than the patient being examined shall be positioned so that no
part of the body will be struck by the useful beam and shall be protected from
scatter radiation by either protective aprons or whole body protective
barriers, of not less than 0.5 millimeter lead equivalent material.
(j) Patients who cannot be removed from the room
shall be positioned so that the nearest portion of the body is at least 2
meters from the tube head or the image receptor, whichever is closer.
(k) Radiologists shall assess the need for gonad
shielding for diagnostic imaging acquisition including requiring that gonad shielding
of no less than 0.5 millimeter lead equivalent material be used:
(1) For patients who have not passed the
reproductive age; and
(2) During radiographic procedures in which the
gonads are in the useful beam, except for cases in which this would interfere
with the diagnostic procedure.
(l) Persons shall not be exposed to the useful
beam, except for healing arts purposes when such exposure has been authorized by
a licensed practitioner of the healing arts.
(m) Deliberate exposure of a person shall be
prohibited for the following purposes:
(1) Exposure of a person for training,
demonstration, or other non-healing-arts purposes; and
(2) Exposure of a person for the purpose of
healing arts screening except as authorized by He-P 4045.04.
(n) If a patient or image receptor must be
provided with auxiliary support during a radiation exposure:
(1) Mechanical holding devices shall be used
whenever possible;
(2) The written safety procedures, required by
He-P 4045.03(f), shall indicate the requirements for selecting a human holder
and the procedure the human holder shall follow;
(3) The human holder shall be instructed in
personal radiation safety and protected as required by He-P 4045.03(f);
(4) No person shall be used routinely to hold
image receptors or patients;
(5) In cases where
the patient must hold the image receptor, except during intraoral examinations,
any portion of the body other than the area of clinical interest struck by the
useful beam shall be protected by not less than 0.5 millimeter lead equivalent
material;
(6) Each facility shall have lead
equivalent garments or barriers available in sufficient numbers to provide
protection to all personnel who shall be involved with radiation machine
operations and not otherwise shielded; and
(7) All protective apparel or barriers shall be
clearly labeled with its lead equivalence.
(o) Procedures and auxiliary equipment designed
to minimize patient and personnel exposure shall be utilized as follows:
(1) The speed of the screen and film combinations
used shall be the fastest speed consistent with the diagnostic objective of the
examinations;
(2) Film cassettes without intensifying screens
shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard
film packets for intraoral use in dental radiography;
(3) The radiation exposure to the patient shall
be the minimum exposure required to produce images of high diagnostic quality;
(4) Portable or mobile x-ray equipment shall be
used only for examinations where it is impractical to transfer the patient(s)
to a stationary x-ray system;
(5) X-ray systems other than fluoroscopic,
dental, computed tomography, or veterinary systems shall not be utilized in
procedures where the source to patient distance is less than 30 centimeters;
and
(6) If grids are used between the patient and the
image receptor, the grid shall:
a. Be positioned properly;
b. Centered to the central ray; and
c. If of the focused type, be of the proper focal
distance for the SIDs being used.
(p) All persons who are associated with the
operation of an x-ray system shall be subject to the requirements of He-P 4020
through He-P 4022 of these rules.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff
7-21-15; para (c) amd by #12024, INTERIM, eff
10-28-16, EXPIRED: 4-26-17; para (c) amd by
#12215, eff 6-20-17; ss by #13410, eff 7-26-22
He-P 4045.04 Healing Arts Screening.
(a) Any person proposing to conduct a healing
arts screening program shall be preapproved by DHHS/RHS, and shall submit the
following information with the request for approval:
(1) Name, address, and telephone number of the
applicant and, where applicable, the names, addresses, and telephone number(s)
of agents within this State;
(2) A detailed description of the x-ray
examinations proposed in the screening program, including;
a. Diseases or conditions subject to x-ray
examinations;
b. A description of the population to be
examined in the screening program;
c. Technique factors to be used;
d. A description of the diagnostic x-ray quality
control program;
e. A description of procedures to advise persons
screened and their practitioners of the results of the screenings;
f. A description of the procedures for the retention
or disposition of the radiographs and other records pertaining to the x-ray
examinations; and
g. An indication of the frequency of screening
and the anticipated duration of the entire screening program;
(3) An evaluation of any known alternate methods
not involving ionizing radiation which could achieve the goals of the screening
program and reasons why these methods are not used instead of the x-ray
examinations;
(4) An evaluation by a qualified expert of the
x-ray system(s) to be used in the screening program which shall:
a. Show that such system(s) do satisfy all
requirements of these rules; and
b. Include a measurement of patient exposures
from the x-ray examinations to be performed;
(5) The qualifications of each person who will be
operating the x-ray system(s), of those who will be supervising the operators
of the x-ray system(s), the extent of supervision, and the method of work
performance evaluation; and
(6) The name and address of the person who will
interpret the radiograph(s).
(b) If any information submitted to DHHS/RHS
becomes invalid or outdated, DHHS/RHS shall be notified within 15 days.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4045.05 Maintenance Record and Associated
Information. The registrant shall
maintain the following information for each x-ray system or MRI machine for
inspection by DHHS/RHS until the registration requiring records is terminated:
(a) Model and serial numbers of all major
components, and user’s manuals for those components;
(b) Records of shielding reviews and surveys,
where applicable;
(c) Records of calibrations, maintenance, and
modifications performed on the x-ray system(s); and
(d) A copy of all correspondence with DHHS/RHS
regarding that x-ray system.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4045.06 X-Ray System Utilization Log.
(a) Each facility shall maintain or be able to
generate electronically a record containing:
(1) The patient’s name;
(2) The type of examinations; and
(3) The dates the examinations were performed.
(b) When the patient or image receptor must be
provided with human auxiliary support, the name of the human holder shall be
recorded in the patient record for whom the support was provided, or
cross-referenced to the patient record.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15,
EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4045.07 X-Ray Film Processing Facilities and
Practices.
(a) Each registrant using analog image receptors,
such as film, shall have available suitable equipment for handling and
processing radiographic film in accordance with the following provisions:
(1) For manually developed film:
a. Processing tanks shall be constructed of
mechanically rigid, corrosion resistant material;
b. Developer solutions in the developing tanks
shall be maintained at temperatures within the range of 60°F to 80°F (16°C to
27°C);
c. Film shall be
developed in accordance with the time-temperature relationships recommended by
the film manufacturer, or, in the absence of such recommendations, with the
recommendations set forth in Table 4045.1;
d. Devices shall be utilized which will indicate
the actual temperature of the developer solution; and
e. Devices shall be used to signal the passage
of a preset time appropriate to the developing time required;
Table 4045.1 Manual
Time-Temperature Chart
Developer
Solution Temperature (Degrees) (C) (F) |
Minimum Developing Time (Minutes) |
|
26.7 |
80 |
2.0 |
26.1 |
79 |
2.0 |
25.6 |
78 |
2.5 |
25.0 |
77 |
2.5 |
24.4 |
76 |
3.0 |
23.9 |
75 |
3.0 |
23.3 |
74 |
3.5 |
22.8 |
73 |
3.5 |
22.2 |
72 |
4.0 |
21.7 |
71 |
4.0 |
21.1 |
70 |
4.5 |
20.6 |
69 |
4.5 |
20.0 |
68 |
5.0 |
19.4 |
67 |
5.5 |
18.9 |
66 |
5.5 |
18.3 |
65 |
6.0 |
17.8 |
64 |
6.5 |
17.2 |
63 |
7.0 |
16.7 |
62 |
8.0 |
16.1 |
61 |
8.5 |
15.6 |
60 |
9.5 |
(2) For automatic processors and other closed
processing systems:
a. Films shall be
developed in accordance with the time-temperature relationships recommended by
the film manufacturer; or, in the absence of such recommendations, the film
shall be developed using Table 4045.2; and
b. The specified developer solution temperature
and immersion time shall be posted in the darkroom or on the automatic
processor; and
Table 4045.2 Automatic Time-Temperature Chart
Developer
Solution Temperature (C) (F) |
Minimum Immersion Time(1) (Seconds) |
|
35.5 |
96 |
19 |
35.0 |
95 |
20 |
34.5 |
94 |
21 |
34.0 |
93 |
22 |
33.5 |
92 |
23 |
33.0 |
91 |
24 |
32.0 |
90 |
25 |
31.5 |
89 |
26 |
31.0 |
88 |
27 |
30.5 |
87 |
28 |
30.0 |
86 |
29 |
29.5 |
85 |
30 |
(1) Immersion time only, no crossover time
included. |
(3) Processing deviations from the requirements
of He-P 4045.07(a) shall be documented by the registrant in such manner that the
requirements are shown to be met or exceeded.
(b) Each installation using an x-ray system and
analog image receptor shall be subject to the following additional
requirements:
(1) Pass boxes shall be constructed to exclude
light from the darkroom when cassettes are placed in or removed from the boxes;
(2) Pass boxes shall incorporate adequate
shielding from stray radiation to prevent exposure of undeveloped film;
(3) The darkroom shall be light tight;
(4) The darkroom shall use proper safe lighting
such that any film type in use exposed in a cassette to x-rays sufficient to
produce an optical density from 1 to 2 when processed shall not suffer an
increase in density greater than 0.1 (0.05 for mammography) when exposed in the
darkroom for 2 minutes with all safelights on;
(5) If used, daylight film handling boxes shall
preclude fogging of the film;
(6) Darkrooms typically used by more than one
person shall be provided with a method to prevent accidental entry while
undeveloped films are being handled or processed;
(7) Film shall be stored in a cool, dry place and
shall be protected from exposure to stray radiation;
(8) Film in open packages shall be stored in a
light tight container;
(9) Film cassettes and intensifying screens shall
be inspected periodically and shall be cleaned and replaced as necessary, but
at least annually;
(10) Outdated x-ray film shall not be used for
diagnostic radiographs, unless:
a. The film has been stored in accordance with
the manufacturer’s recommendations; and
b. A sample of the film passes a sensitometric test for normal ranges of base plus fog and
speed;
(11) Film developing solutions shall be prepared
in accordance with the directions given by the manufacturer; and
(12) Film developing solutions shall be maintained
in strength by replenishment or renewal so that full development is
accomplished within the time specified by the manufacturer.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4045.08 Facilities Using Computed Radiography (CR)
or Direct Digital Radiography (DDR).
Unless other recommendations are made in writing by a qualified expert,
each registrant using computed radiography (CR) or
direct digital radiography (DDR) modes shall comply with the manufacturer’s or
vendor’s recommendations with regard to:
(a) Exposure
indicator values;
(b) CR cassette erasure frequency; and
(c) Image
evaluation for artifacts, spatial resolution, contrast/noise, and exposure indicator
constancy unless otherwise advised in writing by a qualified expert.
Source. #10893, eff 7-21-15
He-P 4045.09 Veterinarian Facilities – Administrative
Requirements.
(a) All veterinarian facilities
using radiation or MRI machines shall:
(1) Complete registration
procedures as set forth in He-P 4040.04 or He-P 4040.07 for machines in
storage;
(2) Complete a renewal of
registration as set forth in He-P 4040.08; and
(3) Complete shielding evaluations as set forth in He-P 4040.03; and
(b) All veterinarian facilities
shall comply with all other radiation or MRI machine administrative
requirements as specified in He-P 4045, except for He-P 4045.04.
Source. #10893, eff 7-21-15
He-P 4045.10 Non-medical Security Screening System.
(a) All non-medical security screening systems
shall be exempt from the requirements of He-P 4045.03(l) and (m).
(b) Radiation safety surveys shall be conducted on
security screening systems upon installation and after any maintenance or
incident that could have damaged the system that affects the radiation machine
performance.
(c) All non-medical security screening systems
shall follow suggested manufacturer maintenance procedures and operability
checks.
(d) All maintenance and radiation survey records
shall be maintained for review by DHHS/RHS during an inspection.
Source. #12024,
INTERIM, eff 10-28-16, EXPIRED: 4-26-17
New. #12215, eff
6-20-17
PART He-P 4046
USE OF RADIATION MACHINES: GENERAL REQUIREMENTS FOR ALL DIAGNOSTIC AND
VETERINARY X-RAY SYSTEMS
He-P 4046.01 General Requirements for All Diagnostic
X-ray. In addition to the requirements
of He-P 4040 through He-P 4045, all diagnostic x-ray systems shall meet the
following requirements:
(a) The control panel containing the main power
switch shall bear a warning label that shall be legible, accessible to view,
and shall state:
“WARNING: THIS
X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE
FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED”;
(b) For battery-powered x-ray systems, visual
means shall be provided on the control panel to indicate whether the battery is
in a state of charge adequate for proper operation;
(c) Means shall be provided to permit further
limitation of the field;
(d) The radiation emitted by a component other
than the diagnostic source assembly shall not exceed 2 milliroentgens in one
hour at 5 centimeters from any accessible surface of the component when it is
operated in an assembled x-ray system under any conditions for which it was
designed;
(e) Compliance with the requirements of He-P
4046.01(f) shall be determined by measurements averaged over an area of 100
square centimeters with no linear dimension greater than 20 centimeters;
(f) The half-value layer of the useful beam for a
given x-ray tube potential shall not be less than the values shown in Table
4046.1;
Table 4046.1 Tube Potential v. Minimum Half-Value Layer
Design
Operating Range |
Measured
Potential |
Dental
Intraoral Manufactured After 12/1/1980 |
Dental Intraoral
Manufactured on or Before 12/1/1980 (and all other x-ray systems
manufactured before 6/10/2006) |
All X-ray
Systems except Dental Intraoral Manufactured on or after 6/10/2006. |
(k Vp) |
(kVp) |
(Half-Value
Layer mm Aluminum) |
(Half-Value
layer mm Aluminum) |
Half-Value Layer
mm Aluminum) |
Below 51 |
30 |
N/A |
0.3 |
0.3 |
|
40 |
N/A |
0.4 |
0.4 |
|
50 |
1.5 |
0.5 |
0.5 |
51 to 70 |
51 |
1.5 |
1.2 |
1.3 |
|
60 |
1.5 |
1.3 |
1.5 |
|
70 |
1.5 |
1.5 |
1.8 |
Above 70 |
71 |
2.1 |
2.1 |
2.5 |
|
80 |
2.3 |
2.3 |
2.9 |
|
90 |
2.5 |
2.5 |
3.2 |
|
100 |
2.7 |
2.7 |
3.6 |
|
110 |
3.0 |
3.0 |
3.9 |
|
120 |
3.2 |
3.2 |
4.3 |
|
130 |
3.5 |
3.5 |
4.7 |
|
140 |
3.8 |
3.8 |
5.0 |
|
150 |
4.1 |
4.1 |
5.4 |
(g) For capacitor energy storage equipment, compliance
with the requirements of He-P 4046.01(g) and He-P 4046.01(f) shall be
determined with the system fully charged and a setting of 10 mAs for each exposure;
(h) The required minimum half-value layer of the
useful beam shall include the filtration contributed by all materials which are
permanently between the source and the patient;
(i) For x-ray systems
which have variable kVp and variable filtration for
the useful beam, a device shall link the kVp selector
with the filter(s);
(j) Where 2 or more radiographic tubes are
controlled by one exposure switch, the tube or tubes which have been selected
shall be clearly indicated on the x-ray control panel and on or near the
selected tube housing assembly prior to the exposure initiation;
(k) The tube housing assembly supports shall be
adjusted such that the tube housing assembly will remain stable during an
exposure unless tube housing movement is a designed function of the x-ray
system;
(l) Technique factors to be used during an
exposure shall be indicated before the exposure begins;
(m) If automatic exposure controls are used, the
technique factors which are set prior to the exposure shall be indicated;
(n) Indication of technique factors shall be
visible from the operator’s position except in the case of spot-films made by
the fluoroscopist;
(o) Diagnostic x-ray systems and their associated
components used on humans and certified pursuant to the “Performance Standards
for Ionizing Radiation Emitting Products” (21 CFR Part 1020) shall be
maintained in compliance with applicable requirements of that standard; and
(p) All position locking, holding, and centering devices
on x-ray system components and systems shall function as intended.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4046.02 Fluoroscopic X-ray Systems – General
Requirements.
(a) All fluoroscopic x-ray systems used shall be
image intensified or equipped with direct digital receptors.
(b) The fluoroscopic imaging assembly shall be
provided with a primary protective barrier which intercepts the entire
cross-section of the useful beam at any SID.
(c) The x-ray tube used for fluoroscopy shall not
produce x-rays unless the barrier is in position to intercept the entire useful
beam.
(d) X-ray production in the fluoroscopic mode
shall be controlled by a device which requires continuous pressure by the
fluoroscopist for the entire time of any exposure.
(e) When recording serial fluoroscopic images,
the fluoroscopist shall be able to terminate the x-ray exposure(s) at any time.
(f) A means may be provided to permit completion
of any single exposure of the series in progress.
(g) Beam limiting devices manufactured after May 22,
1979, and incorporated in equipment with a variable SID or a visible area of
greater than 300 square centimeters shall provide stepless adjustment of the
x-ray field.
(h) All equipment with a fixed SID and a visible
area of 300 square centimeters or less shall be provided with:
(1) Stepless adjustment of the x-ray field; or
(2) With means to further limit the x-ray field
size at the plane of the image receptor to 125 square centimeters.
(i) If provided,
stepless adjustment shall, permit continuous field size adjustments down to a
minimum field size no greater than 5 centimeters in either length or diameter
at maximum SID.
(j) For rectangular x-ray fields used with
circular image receptors, the error in alignment shall be determined along the
length and width dimensions of the x-ray field which pass through the center of
the visible area of the image receptor.
(k) Fluoroscopic spot-film devices shall meet the
following requirements:
(1) Means shall be provided between the source
and the patient for adjustment of the x-ray field size in the plane of the
image receptor to the size of that portion of the image which has been selected
on the spot-film selector;
(2) The adjustment required in He-P 4046.02
(1)(1) shall be automatically accomplished except when the x-ray field size in
the plane of the image receptor is smaller than that of the selected portion of
the image receptor;
(3) It shall be possible to adjust the x-ray field
size in the plane of the image receptor to a size smaller than the selected
portion of the image receptor;
(4) The minimum field size at the maximum SID
shall be no larger than 5 centimeters in either length or diameter; and
(5) The center of the x-ray field in the plane of
the image receptor shall be aligned with the center of the selected portion of
the image receptor to not more than 2 percent of the SID.
(l) If means exist to override any of the
automatic x-ray field size adjustments required in He-P 4046.02(g) through (l),
that means:
(1) Shall be designed for use only in the event
of system failure;
(2) Shall incorporate a signal visible at the
fluoroscopist's position which will indicate whenever the automatic field size
adjustment is overridden; and
(3) Shall be clearly and durably labeled:
“FOR X-RAY FIELD
LIMITATION SYSTEM FAILURE”.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4046.03 Fluoroscopic X-ray Systems – Exposure Rate
Limits.
(a) Fluoroscopic equipment manufactured on or
before May 19, 1995 provided with manual mode only,
shall not be operable at any combination of tube potential and current which
will result in an exposure rate in excess of 5 roentgens per minute (i.e. air kerma rate in (AKR) excess of 44 mGy
per minute) at the point where the center of the useful beam enters the patient
except as follows:
(1) During recording of fluoroscopic images; or
(2) When an optional high level control is
provided, in which case the limit shall be 10 roentgens per minute (i.e. AKR 88 mGy per minute).
(b) Fluoroscopic equipment manufactured on or
before May 19, 1995 provided with automatic exposure rate control with or
without manual mode shall not be operable at any combination of tube potential
and current which will result in an exposure rate in excess of 10 roentgens per
minute (i.e. AKR in excess of 88 mGy per minute) at
that point where the center of the useful beam enters the patient, except
during recording of fluoroscopic images.
(c) Fluoroscopic equipment manufactured after May
19, 1995 provided with manual mode only, shall not be
operable at any combination of tube potential and current which will result in
an exposure rate in excess of 5 roentgens per minute (i.e. AKR in excess of 44 mGy per minute) at the point where the center of the useful
beam enters the patient.
(d) Fluoroscopic equipment manufactured after May
19, 1995 provided with automatic exposure rate control with or without manual
mode shall not be operable at any combination of tube potential and current
which will result in an exposure rate in excess of 10 roentgens per minute
(i.e. AKR in excess of 88 mGy per minute) at that
point where the center of the useful beam enters the patient, except when an
optional high level control which was an option at the time of purchase is
provided and activated, in which case the limit shall be 20 roentgens per
minute (i.e. AKR 176 mGy per minute).
(e) The exposure rate limits expressed in He-P
4046.04(c) and (d) shall not apply to:
(1) Fluoroscopic
equipment manufactured after May 19, 1995 but before June 10, 2006 when
recording images with film or video camera with the tube in pulsed mode; and
(2) Fluoroscopic equipment manufactured after
June 10, 2006 when recording images from the Image Intensifier for the user
after exposure termination.
(f) If a high level control is provided, it
shall:
(1) Have a
separate means of activation;
(2) Be operable only when continuous manual
activation is provided by the operator; and
(3) Provide a continuous signal audible to the
fluoroscopist when in use.
(g) Any fluoroscopic equipment manufactured after
May 19, 1995 which can produce an exposure rate in
excess of 5 roentgens per minute (i.e. AKR in excess of 44 mGy
per minute) shall be equipped with an automatic exposure rate control.
(h) Compliance with He-P 4046.03 shall be
determined as follows:
(1) If the source is below the x-ray table, the
exposure rate shall be measured one centimeter above the tabletop or cradle;
(2) If the source is above the x-ray table, the
exposure rate shall be measured at 30 centimeters above the tabletop with the
end of the beam-limiting device or spacer positioned as closely as possible to
the point of measurement;
(3) For a C-arm/O-arm type of fluoroscope with
fixed SID, the exposure rate shall be measured 30 centimeters from the input
surface of the fluoroscopic imaging assembly, provided that the end of the
beam-limiting device or spacer is no closer than 30 centimeters from the input
surface of the fluoroscopic imaging assembly;
(4) In a C-arm type fluoroscope having an SID
less than 45 centimeters, the AKR shall be measured at the minimum SSD;
(5) For a dedicated lateral type fluoroscope, the
exposure rate shall be measured at a point 15 centimeters from the centerline
of the x-ray table and in the direction of the x-ray source with the end of the
beam limiting device or spacer positioned as closely as possible to the point
of measurement. If the tabletop,
required in He-P 4046.04(g)(4) is movable, the table shall be positioned as
closely as possible to the lateral x-ray source, with the end of the
beam-limiting device or spacer no closer than 15 centimeters to the centerline
of the x-ray table; and
(6) For a special procedures type C-arm
fluoroscope (angiography, interventional fluoro) with
variable SID, the exposure rate shall be measured at the patient support
located 30 cm from the image intensifier at minimum SID.
(i) Periodic
measurement of entrance exposure rate shall be performed by a qualified expert
for both typical and maximum values as follows:
(1) Such measurements shall be made annually or
after any maintenance of the system which might affect the exposure rate;
(2) Results of these measurements shall be posted
in the vicinity of the control panel to allow the fluoroscopist ready access to
them while using the fluoroscope;
(3) Results of the measurements shall be posted
in the record required in He-P 4045.05(c);
(4) The measurement results shall be stated in roentgens
per minute and include the technique factors used in determining such results;
(5) The name of the person performing the
measurements and the date the measurements were performed shall be included in
the results;
(6) Conditions of periodic measurement of typical
entrance exposure rate are as follows:
a. The measurement shall be made under the
conditions that satisfy the requirements of He-P 4046.03(h);
b. The kVp, mA, and/or
other selectable parameters shall be adjusted to those typical of clinical use
on a 23 cm thick abdomen; and
c. Any x-ray system with automatic exposure rate control shall have
sufficient attenuating material placed in the useful beam to produce kVp, mA, and other selectable parameters to satisfy the
conditions of He-P 4046.04 (i)(6)b; and
(7) Conditions of periodic measurement of maximum
entrance exposure rate are as follows:
a. The measurement shall be made under the
conditions that satisfy the requirements of He-P 4046.04(h);
b. The kVp, mA, and
other selectable parameters shall be adjusted to those settings which give the
maximum entrance exposure rate; and
c. Any x-ray system(s) that incorporates
automatic exposure rate control shall have sufficient attenuative material
placed in the useful beam to produce the maximum entrance exposure rate of the
system.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.04)
He-P 4046.04 Fluoroscopic X-ray Systems – Barrier
Transmitted Radiation Rate Limits.
(a) The exposure rate due to transmission through
the primary protective barrier with the attenuation block in the useful beam,
combined with radiation from the image intensifier, if provided, shall not
exceed 2 milliroentgens per hour at 10 centimeters from any accessible surface
of the fluoroscopic imaging assembly beyond the plane of the image receptor per
roentgen per minute of entrance exposure rate.
(b) The exposure rate due to transmission through
the primary protective barrier combined with radiation from the image
intensifier shall be determined by measurements averaged over an area of 100
square centimeters.
(c) If the source is below the tabletop,
measurements shall be made with the input surface of the fluoroscopic imaging
assembly positioned 30 centimeters above the tabletop.
(d) If the source is above the tabletop and the
SID is variable, the measurement shall be made with the end of the
beam-limiting device or spacer as close to the tabletop as it can be placed,
but no closer than 30 centimeters.
(e) Movable grids and compression devices shall
be removed from the useful beam during the measurement.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.05)
He-P 4046.05 Fluoroscopic X-Ray Systems – Additional
Requirements.
(a) During fluoroscopy and cine-fluorography the
kV and the mA shall be continuously indicated.
(b) The source to skin distance (SSD) shall not
be less than:
(1) 38 centimeters on stationary fluoroscopic
systems manufactured on or after August 1, 1974;
(2) 35.5 centimeters on stationary fluoroscopic
systems manufactured prior to August 1, 1974;
(3) 30 centimeters on all mobile fluoroscopes; or
(4) 20 centimeters for all mobile fluoroscopes
manufactured before June 10, 2006 when used for specific surgical applications;
(5) 19 centimeters for all stationary mobile
C-arm fluoroscopes manufactured on or after June 10, 2006 with a source to
image distance (SID) less than 45 centimeters and labeled for extremity use
only; or
(6) 10 centimeters for all stationary mobile
C-arm fluoroscopes manufactured on or after June 10, 2006 with a source to
image distance (SID) less than 45 centimeters and not labeled for extremity use
only.
(c) Fluoroscopic timers shall:
(1) Be provided to reset the cumulative on-time
of the fluoroscopic x-ray tube;
(2) Not exceed 5 minutes without resetting for
the maximum cumulative time of the timing device;
(3) Indicate the completion of any preset
cumulative on-time with a signal audible to the fluoroscopist; and
(4) Continue to have such signal sound while
x-rays are produced until the timing device is reset.
(d) With the exception of C-arm fluoroscopes, fluoroscopic
table designs in combination with procedures shall be such that no unprotected
part of any staff or ancillary person’s body is exposed to unattenuated
scattered radiation generated under the table.
(e) The attenuation required by He-P 4046. 05(d)
shall not be less than 0.25 millimeter lead equivalent.
(f) With the exception of C-arm fluoroscopes,
equipment configuration when combined with procedures shall be such that no
portion of any staff or ancillary person’s body, except the extremities, is
exposed to the unattenuated scattered radiation generated above the tabletop
unless either:
(1) That person is at least 120 centimeters from
the center of the useful beam; or
(2) The radiation has passed through not less
than 0.25 millimeter lead equivalent material including, but not limited to
drapes, bucky-slot cover panel, or self-supporting curtains, in addition to any
lead equivalency provided by the protective apron.
(g) Upon receipt of a written request, DHHS/RHS
shall grant exemptions to He-P 4046.05(f) where a required sterile field will
not permit the use of normal protective barriers for any fluoroscopic
procedures.
(h) Fluoroscopic systems equipped with spot-film
mode shall meet the exposure reproducibility requirements of He-P 4046 when
operating in the spot-film mode.
(i) Radiation therapy
simulation systems shall be exempt from:
(1) All the requirements of He-P 4046.03;
(2) The requirements of He-P 4046.02 and He-P
4046.04 provided that no person other than the patient is in the x-ray room
when the system is producing x-rays; and
(3) The requirements of He-P 4046.05(c) if such
systems are capable of indicating cumulative exposure
times for individual patients.
(j) Procedures for radiation therapy simulation
systems shall require that the timer be reset between treatments.
(k) All fluoroscopic equipment displays
manufactured on or after June 10, 2006 shall:
(1) Be equipped with means to display the last
image hold (LIH) following exposure termination; and
(2) Display the air kerma
rate and cumulative air kerma at the fluoroscopist’s
working position.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15(from He-P 4046.06)
He-P 4046.06 Radiographic Systems Other Than Fluoroscopic,
Dental Intraoral, or Computed Tomography X-ray Systems.
(a) The useful beam of all radiographic systems
except mammographic, fluoroscopic, dental intraoral or computed tomography
systems shall be capable of being limited to the area of clinical interest.
(b) General purpose stationary and mobile x-ray
systems, including veterinary systems, other than portable, shall meet the
following:
(1) Only x-ray systems provided with means for independent
stepless adjustment of at least two dimensions of the x-ray field shall be
used;
(2) A method shall be provided for visually
defining the perimeter of x-ray field;
(3) The total misalignment of the edges of the
visually defined field compared to the respective edges of the x-ray field
shall not exceed 2 percent of the distance from the source to the center of the
visually defined field when it is perpendicular to the axis of the x-ray beam;
(4) DHHS/RHS may grant non-certified x-ray
systems an exemption from the requirements of He-P 4046.06(b)(1), (2), and (3)
provided the registrant makes a written application for such exemption, and in
that application:
a. Demonstrates it is impractical to comply with
He-P 4046. 06(b); and
b. Describes how the purpose of He-P 4046. 06(b)
will be met by other methods;
(5) In addition to the requirements of He-P
4046.06(b)(1)-(4), stationary general purpose x-ray systems shall meet the
following requirements:
a. Methods shall be provided to indicate when
the axis of the x-ray beam is perpendicular to the plane of the image receptor,
to align the center of the x-ray field to the center of the image receptor to
not more than 2 percent of the SID;
b. The beam-limiting device shall indicate
numerically the field size in the plane of the image receptor to which it is
adjusted;
c. Indication of field size dimensions and SIDs
shall be specified in inches and centimeters; and
d. X-ray field dimensions in the plane of the
image receptor shall correspond to those indicated by the beam-limiting device
to not more than 2 percent of the SID when the beam axis is perpendicular to the plane of the image
receptor; and
(6) X-ray systems designed for only one image
receptor size at a fixed SID shall:
a. Be provided with means to limit the field at
the plane of the image receptor to dimensions no greater than those of the
image receptor; and
b. Align the center of the x-ray field with the
center of the image receptor to not more than
2 percent of the SID.
(c) X-ray systems other than those described in
He-P 4046.06, and all veterinary x-ray systems shall meet the following when
the axis of the x-ray beam is perpendicular to the plane of the image receptor:
(1) Means shall be provided to limit the x-ray
field within, and perpendicular to the plane of the image receptor such that the field does not exceed each dimension
of the image receptor by more than 2 percent of the SID; and
(2) Means shall be provided to align the center
of the x-ray field with the center of the image receptor to not more than 2
percent of the SID.
(d) Means shall be provided to initiate the
radiation exposure only by a deliberate action on the part of the operator.
(e) An exposure shall not be possible when the
timer is set to a “zero” or “off” position.
(f) Means shall be provided for visual indication
observable at or from the operator’s protected position whenever x-rays are
produced.
(g) A signal audible to the operator shall
indicate that the exposure has terminated.
(h) Means shall be provided to terminate the
exposure at:
(1) A preset time interval or number of pulses;
(2) A preset product of current and time; or
(3) A preset radiation exposure to the image
receptor.
(i) Except for dental
panoramic systems, termination of an exposure shall cause automatic resetting
of the timer to its initial setting or to “zero.”
(j) An x-ray control shall be incorporated into
each x-ray system such that an exposure can be terminated manually, by the
operator, at any time except for:
(1) Exposures of one-half second or less; or
(2) Serial radiography when means shall be
provided to permit completion of any single exposure of the series in process.
(k) When an automatic exposure control is
provided:
(1) The control panel shall indicate when this
mode of operation is selected;
(2) If the x-ray tube potential is equal to or
greater than 51 kVp, the minimum exposure time for
pulsed operation shall be equal to 2 pulses;
(3) The minimum exposure time for all equipment
other than specified in He-P 4047. 06(k)(2) shall be no greater than
one-sixtieth (1/60) second, or a time interval required to deliver 5 mAs, whichever is greater; and
(4) Manual exposure resetting shall be required
before further timed exposures can be made.
(l) For systems having independent selection of
exposure time settings, the average ratios (Xi) of exposure to the
indicated timer setting, in units of milliroentgens per second (mR/s), obtained at any two clinically used timer settings
shall not differ by more than 0.10 times their sum. This is written as:
where X1
and X2 are the average mR/s values.
(m) The x-ray exposure control shall be so placed
that the operator can view the patient while making any exposure.
(n) Stationary x-ray systems, except veterinary
systems, shall be required to have the x-ray control permanently mounted in a
protected area that by virtue of shielding or distance or both shall protect
the operator during the entire exposure from radiation scatter and is
sufficient to comply with the occupational dose limits required by He-P
4020.05.
(o) Mobile and portable x-ray systems, except
veterinary systems shall meet the requirements of He-P 4046.06(n) if used
continuously for greater than one week in the same location, and shall be
provided with means to limit the source to skin distance equal to, or greater
than 30 centimeters.
(p) All stationary, mobile
or portable x-ray systems used for veterinary work shall be provided:
(1) With a 2 meter (6.5 feet) high protective barrier
for operator protection during exposures or
(2) With means to allow the operator to be at
least 2.7 meters (9 feet) from the tube housing assembly during the exposure.
(q) All mobile or portable radiographic systems,
except veterinary systems, shall be provided with means to limit the
source-to-skin distance to equal to or greater than 30 centimeters.
(r) When all technique factors are held constant,
including control panel selections associated with automatic exposure control
systems, the coefficient of variation of exposure for both manual and automatic
exposure control systems shall not exceed 0.05.
(s) Radiation emitted from the x-ray tube when
the system is fully charged and the exposure switch or timer is not activated
shall not exceed a rate of 2 milliroentgens per hour (mR/hr) at 5 centimeters from any accessible surface of the
diagnostic source assembly, with the beam-limiting device fully open.
(t) Deviation of measured technique factors
shall:
(1) Not exceed 10 percent of the indicated kVP value unless allowed by the manufacturer’s written
specification; and
(2) Not exceed 20 percent of the exposure time,
which is either indicated or which can be inferred from known mA or mAs values, unless allowed by the manufacturer’s written
specification.
(u) When equipment having independent selection
of x-ray tube current (mA), or a combined x-ray tube current exposure time
product (mAs), is operated between 40 percent and 100
percent of the maximum rated kVp, the absolute value
of the difference in the ratios (Xi) of exposure to the indicated
milliampere-seconds product mR/mAs
obtained at any two consecutive tube current settings shall not differ by more
than 0.10 times their sum:
where the values
of X1 and X2 are the average values which are obtained at
each of two consecutive tube current settings, or are obtained at two settings
differing by no more than a factor of 2 where the tube current selection is
continuous.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.07)
He-P 4046.07 Certified Diagnostic Systems Only. Diagnostic x-ray systems incorporating one or
more certified component(s) shall be required to comply with the following:
(a) For beam limitation for stationary and mobile
general purpose x-ray systems, the following shall be provided:
(1) A means of stepless adjustment of the size of
the x-ray field;
(2) A minimum field size at an SID of 100 centimeters
equal to or less than 5 centimeters by 5 centimeters;
(3) A light localizer, if used to define the
x-ray field, shall provide an average illumination, based upon measurements
made in the approximate center of each quadrant of the light field, of not less
than 160 lux or 15 foot-candles at 100 centimeters or the maximum SID,
whichever is less; and
(4) Radiation therapy simulation systems
manufactured on and after May 27, 1980, are exempt from the requirement of He-P
4046.07(a)(3);
(b) For beam limitation on stationary general
purpose x-ray systems equipped with positive beam limitation (PBL), the
following requirements shall be met:
(1) The PBL system shall be capable of operation,
at the discretion of the operator, such that the size of the field may be made
smaller than the size of the image receptor through stepless adjustment of the
field size;
(2) The minimum field size at an SID of 100
centimeters shall be equal to or less than 5 centimeters by 5 centimeters; and
(3) The PBL system shall function such that any
change of image receptor size or SID shall cause the automatic return to PBL;
(c) Beam limitation for portable x-ray systems
shall meet the beam limitation requirements of He‑P 4046.07(a) or (b) as
applicable;
(d) A tube stand or other mechanical support
shall be used for portable x-ray systems, so that the x-ray tube housing
assembly need not be hand-held during exposures; and
(e) Hand-held dental intraoral x-ray systems
shall not be subject to the requirements of He-P 4046.07(d).
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.08)
He-P 4046.08 Dental Intraoral Radiographic Systems. In addition to the provisions of He-P 4045
and He-P 4046.01, the requirements of this section shall apply to x-ray systems
used for dental radiography:
(a) X-ray systems designed for use with an
intraoral image receptor shall be provided with means to limit SSD, to not less
than:
(1) 18 centimeters if operable above 50 kVp; or
(2) 10 centimeters if operable at 50 kVp only;
(b) X-ray systems designed for use with an intraoral
image receptor shall be provided with means to limit the x-ray beam such that
the beam at the minimum SSD shall be containable in a circle having a diameter
of no more than 7 centimeters;
(c) The radiation exposure control shall meet the
following requirements:
(1) No radiation exposure shall occur unless
initiated by the operator;
(2) It shall not be possible to make an exposure
when the timer is set to a “zero” or “off” position is provided;
(3) A visual indication of x-ray production shall
be observable by the operator;
(4) An audible signal to the operator shall
indicate that the exposure has terminated;
(5) Means shall be provided to terminate the
exposure at a preset time interval, preset product of current and time, a
preset number of pulses, or a preset radiation exposure to the image receptor;
(6) Exposures can be terminated by the operator
at any time, except for exposures of 0.5 second or less;
(7) Termination of an exposure shall cause
automatic resetting of the timer to its initial setting or to “zero”;
(8) Stationary intraoral systems shall be
required to have the x-ray exposure control permanently mounted in a protected
area, so that the operator is required to remain in that protected area during
the entire exposure;
(9) Mobile intraoral systems which are:
a. Used for greater than one week in the same
location, i.e., a room or suite, shall meet the requirements of He-P
4046.08(c)(8); or
b. Used for less than one week in the same
location shall be provided with either a protective barrier at least 2 meters
(6.5 feet) high for operator protection, or means to allow the operator to be
at least 2.7 meters (9 feet) from the tube housing assembly while making
exposures; and
(10) Hand-held dental intraoral x-ray machines
shall not be subject to the requirements of He-P 4046.08(c)(8) and He-P
4046.08(c)(9);
(d) When the equipment is operated on an adequate
power supply as specified by the manufacturer, the estimated coefficient of
variation of radiation exposures shall be no greater than 0.05, for any
specific combination of selected technique factors;
(e) Deviation of technique factors from indicated
values for kVp and exposure time shall not exceed the
limits specified for that system by its manufacturer or in the absence of
manufacturer’s specifications the deviation shall not exceed 10 percent of the
indicated value for kVp and 20 percent for time;
(f) Dental x-ray systems with a nominal fixed kVp of less than 50 kVp shall not
be used to make diagnostic dental radiographs of humans; and
(g) The following administrative controls shall
be in place:
(1) Patient and image receptor holding devices
shall be used when the techniques permit;
(2) Neither the tube housing nor any position
indicating device (PID) such as a Rinn kit shall be hand-held during an
exposure; and
(3) Dental fluoroscopy without image
intensification shall not be used.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.09)
He-P 4046.09 Hand-held Dental Intraoral Machines. The following requirements shall apply to the
use of hand-held dental intraoral machines:
(a) For all uses:
(1) The registrant shall follow all applicable
requirements set forth in the New Hampshire Rules for the Control of Radiation
(NHRCR), as well as all manufacturers’s requirements;
(2) The machine shall be used only for dental
diagnostic imaging;
(3) The protective shielding shall not be removed
or modified;
(4) The registrant shall provide a copy of their
operating, safety and security procedures to operators
to prevent unauthorized or improper use;
(5) The registrant shall prepare a quality
assurance plan, with an emphasis on ensuring limited retaking of radiographs;
(6) Operators of hand-held dental intraoral
machines shall be specifically trained to operate such equipment, and the
registrant shall provide proof of training for all operators;
(7) When operating a hand-held dental intraoral
machine, operators shall wear a lead apron as well as an extremity dosimeter on
the hand closest to the protective shielding;
(8) A hand-held dental intraoral machine shall be
held without any motion during a patient examination. A tube stand or Rinn kit may be utilized to
immobilize a hand-held dental intraoral radiographic unit during patient
examination;
(9) Operators of hand-held dental intraoral
machines shall provide a secondary protective barrier for patients; and
(10) The operator shall ensure that there are no
bystanders within a radius of at least 6 feet (2 meters), from the patient
being examined with a hand-held intraoral machine.
(b) Additional requirements for operatories in
permanent facilities:
(1) Hand-held dental intraoral machines shall be
used for patient examinations only in dental operatories that meet the
structural shielding requirements specified by DHHS/RHS or by a qualified
expert;
(2) Hand-held dental intraoral machines shall not
be used for patient examinations in hallways and waiting rooms; and
(3) For battery-powered units, visual means shall
be provided on the control panel to indicate whether the battery is in a state
of charge adequate for proper operation.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4046.10 Dental Cone-Beam CT (CBCT). Dental systems shall be:
(a) Certified by the manufacturer pursuant to the
Medical Device Act and Subchapter C-Electronic Product Radiation Control (EPRC)
of Chapter V of the Federal Food, Drug and Cosmetic Act;
(b) Registered in accordance with He-P 4040;
(c) Maintained and operated in accordance with
the manufacturer’s specification; and
(d) Operated by persons who have been
specifically trained by the manufacturer.
Source. #6827, eff 8-6-98; ss byD,
INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763,
INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15
He-P 4046.11 Computed Tomography X-ray System
Requirements.
(a) Automatic termination of x-ray exposures in the
event of equipment failure shall occur either by de-energizing the x-ray source
or shuttering the x-ray beam.
(b) Termination as required in He-P 4046.11(a)
above shall occur within an interval that limits the total scan time to no more
than 110 percent of its preset value.
(c) Premature termination of the x-ray exposure
by the operator shall require resetting of the CT conditions of operation prior
to initiation of another scan.
(d) A visible signal shall indicate when the
x-ray exposure has been terminated.
(e) The operator shall be able to terminate the
x-ray exposure at any time during a scan of greater than one-half second
duration.
(f) For any single tomogram system, means shall
be provided to permit visual determination of the tomographic plane or a
reference plane offset from the tomographic plane.
(g) For any multiple tomogram system, means shall
be provided to permit visual determination of the location of a reference
plane.
(h) If a device using a light source is used to
satisfy the requirements of He-P 4046.11(f) or (g) above, the light source
shall provide illumination levels sufficient to permit visual determination of
the location of the tomographic plane or reference plane under ambient light
conditions of up to 500 lux.
(i) The CT x-ray
control and gantry shall provide visual indication whenever x-rays are produced
and, if applicable, whether the shutter is open or closed.
(j) Each emergency button or switch shall be
clearly labeled as to its function.
(k) The CT conditions of operation to be used
during a scan or a scan sequence shall be indicated prior to the initiation of
a scan or a scan sequence.
(l) Indication of CT conditions of operation
shall be visible from any position from which scan initiation is possible.
(m) The angular position where the maximum
surface CTDI occurs shall be identified to allow for reproducible positioning
of a CT dosimetry phantom.
(n) Additional requirements applicable to CT
X-ray systems containing a gantry manufactured after September 3, 1985 shall be
as follows:
(1) The total error in the indicated location of
the tomographic plane or reference plane shall not exceed 5 millimeters;
(2) If the x-ray production period is less than
one-half second, the indication of x-ray production shall be actuated for at
least one-half second;
(3) Indicators at or near the gantry shall be
discernible from any point external to the patient opening;
(4) The deviation of indicated scan increment
versus actual increment shall not exceed plus or minus one millimeter with any
mass from 0 to 100 kilograms resting on the support device; and
(5) The patient support device shall be
incremented from a typical starting position to the maximum incremented
distance or 30 centimeters, whichever is less, and then returned to the
starting position. Measurement of actual versus indicated scan increment may be
taken anywhere along the incremented distance.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.11)
He-P 4046.12 Computed Tomography X-ray Systems –
Facility Design Requirements.
(a) Provision shall be made for 2-way aural
communication between the patient and the operator at the control panel.
(b) Windows, mirrors, closed-circuit television,
or an equivalent shall be provided to permit continuous observation of the
patient during irradiation and shall be so located that the operator can
observe the patient from the control panel.
(c) When the primary viewing system is by
electronic means, an alternate viewing system shall be available for use in the
event of failure of the primary viewing system.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.11)
He-P 4046.13 Computed Tomography X-ray Systems –
Surveys, Calibrations, Spot Checks, and Operating Procedures.
(a) All CT x-ray systems shall have a survey made
by or under the direction of a qualified expert.
(b) The registrant shall obtain a written report
of the survey from the qualified expert, and a copy of the report shall be made
available to DHHS/RHS upon request.
(c) The calibration of the radiation output of
the CT x-ray system shall be performed by or under the direction of a qualified
expert who is physically present at the facility during such calibration.
(d) The calibration of a CT x-ray system shall be
performed at intervals specified by a qualified expert and after any change or
replacement of components which, in the opinion of the qualified expert, could
cause a change in the radiation output.
(e) The calibration of the radiation output of a
CT x-ray system shall be performed with a calibrated dosimetry system which is
traceable to a national standard and has been calibrated within the preceding 2
years.
(f) CT dosimetry phantom(s) shall meet the
following specifications and conditions of use shall be used in determining the
radiation output of a CT X-ray system:
(1) CT dosimetry phantom(s) shall be right
circular cylinders of polymethyl methacrylate of density 1.19 plus or minus
0.01 grams per cubic centimeter;
(2) The phantom(s) shall be at least 14
centimeters in length and shall have diameters of 32.0 centimeters for testing
CT x-ray systems designed to image any section of the body and 16.0 centimeters
for systems designed to image the head or for whole body scanners operated in
the head scanning mode;
(3) CT dosimetry phantom(s) shall provide means
for the placement of a dosimeter(s) along the axis of rotation and along a line
parallel to the axis of rotation 1.0 centimeter from the outer surface and
within the phantom; and
(4) All dose measurements shall be performed with
the CT dosimetry phantom placed on the patient couch or support device without
additional attenuation materials present.
(g) The calibration shall be required for each
type of head, body, or whole-body scan performed at the facility.
(h) Calibration shall meet the following
requirements:
(1) The dose profile along the center axis of the
CT dosimetry phantom for the minimum, maximum, and midrange values of the
nominal tomographic section thickness used by the registrant shall be
measurable;
(2) Where less than 3 nominal tomographic
thicknesses can be selected, the dose profile determination shall be performed
for each available nominal tomographic section thickness;
(3) The CTDI along the two axes specified in He-P
4046.02 (l)(1) shall be measured;
(4) The CT dosimetry phantom shall be oriented so
that the measurement point 1.0centimeter from the outer surface and within the
phantom is in the same angular position within the gantry as the point of
maximum surface CTDI identified; and
(5) The CT conditions of operation shall
correspond to typical values used by the registrant for body parts represented
by that phantom type.
(i) Calibration
procedures shall be in writing.
(j) Records of calibrations performed shall be
maintained for inspection by DHHS/RHS.
(k) The spot check procedures shall be in writing
and shall have been developed by a qualified expert.
(l) The spot check procedures shall incorporate
the use of a CT dosimetry phantom capable of providing an indication of
contrast scale, noise, nominal tomographic section thickness, resolution
capability of the system for low and high contrast objects, and measuring the
mean CTN for water or other reference material.
(m) All spot checks shall be included in the CT
calibration and at time intervals and under system conditions specified by a
qualified expert.
(n) Spot checks shall include acquisition of
images obtained with the CT dosimetry phantom(s) using the same processing mode
and CT conditions of operation as are used to perform calibrations.
(o) The spot check images shall be retained,
until a new calibration is performed, as images stored in digital form on a
backed-up storage medium compatible with the CT x-ray system.
(p) Written records of the spot checks performed
shall be maintained for inspection by DHHS/RHS.
(q) The CT x-ray system shall not be operated except
by a person who has been specifically trained in its operation.
(r) Information shall be available at the control
panel regarding the operation and calibration of the system to include the
following:
(1) Dates of the latest calibration and
spot-checks and the location within the facility where the results of those
tests may be obtained;
(2) Instructions on the use of the CT dosimetry
phantom(s) including a schedule of spot-checks appropriate for the system,
allowable variations for the indicated parameters, and the results of at least
the most recent spot-checks conducted on the system;
(3) The distance in millimeters between the
tomographic plane and the reference plane if a reference plane is utilized;
(4) A current technique chart available at the
control panel which specifies for each routine examination the CT conditions of
operation and the number of scans per examination; and
(5) If the calibration or spot- check of the CT
x-ray system identifies that a system operating parameter has exceeded a
tolerance established by the qualified expert, use of the CT x-ray system on
patients shall be limited to those uses permitted by established written
instructions of the qualified expert.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10893,
eff 7-21-15 (from He-P 4046.12)
He-P 4046.14 Mammography X-ray System Requirements.
(a) In addition to other rules pertaining to
radiation safety, registration and use of radiation
machines, only radiation machines pursuant to the “Mammography Quality
Standards Reauthorization Act of 1998,” Public Law 105-248, and 21 CFR Part
900, shall be used for screening and diagnostic mammography.
(b) A facility performing screening and
diagnostic mammography shall have a valid certificate issued by the US
Department of Health and Human Services, pursuant to the “Mammography Quality
Standards Reauthorization Act of 1998,” Public Law 105-248, and 21 CFR Part
900.
Source. #8808, eff 1-24-07; ss by #10763, INTERIM,
eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.13)
He-P 4046.15 Bone Densitometry.
(a) When an application for registration of a new
or additional bone densitometry machines is received by DHHS/RHS in accordance
with He-P 4040, registration shall be denied unless the application is
accompanied by the following information:
(1) A detailed description of the x-ray
examinations proposed in the screening program;
(2) A description of the diagnostic x-ray quality
control program;
(3) The qualifications of each person who will be
operating the x-ray system(s);
(4) The qualifications of the person who will be
supervising the operators of the x-ray systems(s), the extent of supervision,
and the method of work performance evaluation; and
(5) The name and address of the person who will
interpret the radiograph(s).
(b) Bone densitometry systems shall be:
(1) Certified by the manufacturer pursuant to the
Medical Device Act and Subchapter C- Electronic Product Radiation Control
(EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;
(2) Licensed in accordance with He-P 4040 of
these regulations; and
(3) Maintained and operated in accordance with
the manufacturer’s specifications.
(c) Bone densitometry systems with a stepless
beam limitation device shall be provided with means to both size and align the
x-ray field such that at a plane of the image receptor the x-ray field does not
extend beyond 2 percent of the SID.
(d) Operators of bone densitometry systems shall
be:
(1) Licensed as a practitioner of the healing
arts; or
(2) Complete a training course on bone
densitometry which is provided by the densitometer manufacturer or vendor, and
which shall include:
a. Basic radiation protection;
b. Operating procedures for bone densitometry
systems, to include use of various system functions, safety
and maintenance; and
c. Patient positioning for the types of
examinations performed.
(e) During the operation of any bone densitometry
system:
(1) The operator, ancillary personnel, and
members of the general public shall be positioned at
least one meter from the patient and bone densitometry system during the
examination; and
(2) The operator shall advise the patient that
the bone densitometry examination is a type of x-ray procedure.
(f) The registrant shall keep maintenance records
for bone densitometry records as prescribed by He-P 4045.05. These records shall be maintained for
inspection DHHS/RHS for a minimum period of 5 years.
(g) Bone densitometry on human patients shall be
conducted only under the prescription of a licensed practitioner of the healing
arts.
Source. #10893, eff 7-21-15 (from He-P 4046.14)
He-P 4046.16 Veterinarian Facilities – Radiation or MRI
Machine General Requirements.
(a) All veterinarian facilities shall be subject
to the following requirements:
(1) Radiation machine general requirements set
forth in He-P 4046.01; and
(2) Tube potential vs., minimum half-value layer
set forth in Table 4046.1.
(b) Veterinarians using fluoroscopic systems
shall be subject to requirements for:
(1) General requirements and activation of the fluoro tube set forth in He-P 4046.02;
(2) Barrier transmitted exposure rate limits set
forth in He-P 4046.04;
(3) Additional requirements set forth in He-P
4046.05; and
(4) Certified diagnostic systems set forth in
He-P 4046.07.
(c) Veterinarians using dental intraoral systems
shall be subject to the requirements for:
(1) Dental intraoral radiographic systems, other
than hand-held systems set forth in He-P 4046.08; and
(2) Hand-held dental intraoral systems set forth
in He-P 4046.09.
(d) Veterinarians using computed tomography
systems shall be subject to requirements for:
(1) Equipment requirements set forth in He-P
4046.11;
(2) Facility design requirements set forth in
He-P 4046.12; and
(3) Surveys, calibrations, spot checks, and
operating conditions set forth in He-P 4046.13.
Source. #10893, eff 7-21-15
He-P 4046.17 Magnetic Resonance Imaging (MRI) Systems. MRI systems shall be:
(a) Certified by the manufacturer pursuant to the
Medical Device Act and Subchapter C-Electronic Product Radiation Control (EPRC)
of Chapter V of the Federal Food, Drug and Cosmetic Act;
(b) Registered in accordance with He-P 4040; and
(c) Maintained and operated in accordance with
the manufacturer’s specifications.
Source. #10893, eff 7-21-15
PART He-P 4047
USE OF RADIATION MACHINES: THERAPEUTIC RADIATION MACHINES
He-P 4047.01 Purpose. He-P 4047 establishes requirements, for which
the registrant is responsible for use of therapeutic radiation machines.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.02 Scope.
The provisions of He-P 4047 are in addition to, and are not
substitutions for, other applicable provisions of these rules.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.03 Definitions. The following definitions apply specifically
to Part He-P 4047 and are in addition to definitions in He-P 4003 and He-P
4041.
(a) “Absorbed dose (D)” means the mean energy
imparted by ionizing radiation to matter, and is determined as the quotient of dE by dm, where dE is the mean
energy imparted by ionizing radiation to matter of mass dm, and is expressed in
the SI unit of joule per kilogram and the special name “gray” (Gy).
(b) “Absorbed dose rate” means absorbed dose per
unit time for radiation machines with timers, or dose monitor unit per unit
time for linear accelerators.
(c) “Air kerma (K)” means
the kinetic energy released in air by ionizing radiation, and is determined as
the quotient of dE by dM,
where dE is the sum of the initial kinetic energies
of all the charged ionizing particles liberated by uncharged ionizing particles
in air of mass dM, and is expressed in the SI unit of
joule per kilogram, and the special name the “gray” (Gy).
(d) “Beam scattering foil” means a thin piece of
material placed in the beam to scatter a beam of electrons in
order to provide a more uniform electron distribution in the useful
beam.
(e) “Bent beam linear accelerator” means a linear
accelerator geometry in which the accelerated electron beam must change
direction by passing through a bending magnet.
(f) “Conventional Simulator” means any x-ray
system designed to produce the geometric conditions of the radiation therapy
equipment.
(g) “Dose monitor unit (DMU)” means a unit
response from the beam monitoring system from which the absorbed dose can be
calculated.
(h) “Dosimetrist” means a person who generates
and calculates radiation dose distributions under the direction of a medical
physicist and a radiation oncologist.
(i) “Electronic brachytherapy”
means a method of radiation therapy where an electrically generated source of
ionizing radiation is placed in or near the tumor or target tissue to deliver
therapeutic radiation dosage.
(j) “Electronic brachytherapy device” means the
system used to produce and deliver therapeutic radiation including the x-ray
tube, the control mechanism, the cooling system and
the power source.
(k) “Electronic brachytherapy source” means the
x-ray tube component used in an electronic brachytherapy device.
(l) “External beam radiation therapy” means
therapeutic irradiation in which the source of radiation is at a distance from
the body.
(m) “Field-flattening filter” means a filter used
to homogenize the absorbed dose rate over the radiation field.
(n) “Gantry” means that part of a radiation
therapy system supporting and allowing movements of the radiation head about a
center of rotation.
(o) “High energy external beam therapy” means
photons and electrons with energies greater than equal to one MV or one MeV.
(p) “Intensity Modulated Radiation Therapy
(IMRT)” means radiation therapy that uses non-uniform radiation beam
intensities which have been determined by various computer based and automated
optimization techniques.
(q) “Interruption of irradiation” means the
stopping of irradiation with the possibility of continuing irradiation without
resetting of operating conditions at the control panel.
(r) “Kilovolt (kV)” or “kilo electron volt (keV)”
means the energy equal to that acquired by a particle with one electron charge
in passing through a potential difference of one thousand volts in a vacuum.
(s) “Megavolt (MV)” or “mega electron volt (MeV)”
means the energy equal to that acquired by a particle with one electron charge
in passing through a potential difference of one million volts in a vacuum.
(t) “Misadministration” means the administration
of an external beam radiation therapy dose:
(1) Involving the wrong patient;
(2) Involving the wrong treatment modality;
(3) Involving the wrong treatment site;
(4) When the treatment consists of 3 or fewer
fractions and the calculated total administered dose differs from the total
prescribed dose by more than 10 percent of the total prescribed dose;
(5) When the calculated weekly administered dose
differs from the weekly prescribed dose by more than 30 percent; or
(6) When the calculated total administered dose
differs from the total prescribed dose by more than 20 percent of the total
prescribed dose.
(u) “Mobile Electronic Brachytherapy Service”
means transportation of an electronic brachytherapy device to provide
electronic brachytherapy at an address that is not the address of record.
(v) “Monitor unit (MU)” means “dose monitor unit”
as defined in He-P 4047.03(g).
(w) “Moving beam radiation therapy” means
radiation therapy with any planned displacement of radiation field or patient
relative to each other, or with any planned change of absorbed dose
distribution.
(x) “Nominal treatment distance” means:
(1) For electron radiation, the distance from the
scattering foil, virtual source, or exit window of the electron beam to the
entrance surface of the irradiation object along the central axis of the useful
beam;
(2) For x-ray irradiation, the virtual source or
target to isocenter distance along the central axis of the useful beam; and
(3) For non-isocentric x-ray
irradiation equipment, the distance along the central axis shall be that
specified by the manufacturer.
(y) “Periodic quality assurance check” means a
procedure which is performed to ensure that a previous calibration continues to
be valid.
(z) “Phantom” means an object behaving in
essentially the same manner as tissue, with respect to absorption or scattering
of the ionizing radiation in question.
(aa) “Practical range of electrons” means a
classical electron range where the only remaining contribution to dose is from
bremsstrahlung x-rays.
(ab) “Prescribed dose” means the total dose and
dose per fraction as documented in the written directive.
(ac) “Primary dose monitoring system” means a
system which will monitor the useful beam during irradiation and which will
terminate irradiation when a pre-selected number of dose monitor units have
been delivered.
(ad) “Radiation field” means “useful beam” as
defined in He-P 4041(dq).
(ae) “Radiation head” means the structure from
which the useful beam emerges.
(af) “Radiation
Therapy Physicist” means an individual qualified in accordance with He‑P
4047.
(ag) “Recordable event” means the administration of
an external beam radiation therapy dose when the calculated weekly administered
dose differs by 15 percent or more from the weekly prescribed dose.
(ah) “Redundant beam monitoring system” means a
combination of 2 dose monitoring systems in which each system is designed to
terminate irradiation in accordance with a pre-selected number of dose monitor
units.
(ai) “Scattered primary radiation” means that
scattered radiation which has been deviated in direction only by materials
irradiated by the useful beam.
(aj) “Secondary dose
monitoring system” means a system which will terminate irradiation in the event
of failure of the primary dose monitoring system.
(ak) “Shadow tray”
means a device attached to the radiation head to support auxiliary beam
blocking material.
(al) “Simulator” or “radiation therapy simulation
system” means an x-ray system intended for localizing the volume to be exposed
during radiation therapy and reproducing the position and size of the
therapeutic irradiation field.
(am) “Source-skin distance (SSD)” means
“target-skin distance” as defined in He-P 4047.03(ap).
(an) “Stationary beam radiation therapy” means
radiation therapy without displacement of one or more mechanical axes relative
to the patient during irradiation.
(ao) “Target” means
that part of an x-ray tube or accelerator onto which is directed a beam of
accelerated particles to produce ionizing radiation or other particles.
(ap) “Target-skin distance (TSD)” means the
distance measured along the beam axis from the center of the front surface of
the x-ray target and/or electron virtual source to the surface of the
irradiated object or patient.
(aq) “Therapeutic
radiation machine” means x-ray or electron producing equipment designed and
used for external beam radiation therapy.
For the purpose of these regulations, devices
used to administer electronic brachytherapy shall also be considered
therapeutic machines.
(ar) “Virtual
Simulator” means a computed tomography (CT) unit used in conjunction with
relevant software which recreates the treatment machine; and that allows import
manipulation, display and storage of images from CT
and/or other imaging modalities.
(as) “Virtual source” means a point from which radiation
appears to originate.
(at) “Written directive” means an order in writing
for a specific patient, dated and signed by an authorized user prior to the
administration of radiation which contains the total dose, dose per fraction,
treatment site, and overall treatment period.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.04 General Administrative Requirements for
Facilities Using Therapeutic Radiation Machines.
(a) The use of therapeutic radiation machines
shall be by, or under the supervision of, a licensed practitioner of the
healing arts.
(b) The registrant shall be responsible for
directing the operation of the therapeutic radiation machines which have been
registered with DHHS/RHS.
(c) The registrant shall ensure that the
requirements of Part He-P 4047 are met in the operation of the therapeutic
radiation machine(s).
(d) A therapeutic radiation machine which does not
meet the provisions of these rules shall not be used for irradiation of
patients.
(e) The registrant for any therapeutic radiation
machine subject to He-P 4047 shall require the authorized user to be a
physician who:
(1) Is certified in:
a. Radiation oncology or therapeutic radiology
by the American Board of Radiology; or
b. Radiation oncology by the American
Osteopathic Board of Radiology; or
c. Radiology, with specialization in
radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of
the Royal College of Radiology”; or
d. Therapeutic radiology by the Canadian Royal
College of Physicians and Surgeons; or
(2) Is in the active practice of therapeutic
radiology, and has:
a. Completed 200 hours of instruction in basic
radiation techniques applicable to the use of an external beam radiation
therapy unit;
b. Completed 500 hours of supervised work
experience; and
c. A minimum of 3 years supervised clinical
experience.
(f) To satisfy the requirement for instruction in
He-P 4047.04(e)(2)a., the classroom and laboratory training shall include:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and
measurement of ionization radiation; and
(4) Radiation biology.
(g) To satisfy the requirement for supervised
work experience in He‑P 4047.04(e)(2)b., training shall:
(1) Be under the supervision of an authorized
user; and
(2) Include:
a. Review of the full calibration measurements
and periodic quality assurance checks;
b. Evaluation of prepared treatment plans;
c. Calculation of treatment times and patient
treatment settings;
d. Use of administrative controls to prevent misadministrations;
e. Implementation of emergency procedures to be
followed in the event of the abnormal operation of a external beam radiation therapy unit or console;
and
f. The checking and use of radiation survey
meters.
(h) To satisfy the requirement for a period of
supervised clinical experience in He-P 4047.04(e)(2)c., training shall include:
(1) One year in a formal training program
approved by:
a. The Residency Review Committee for Radiology
of the Accreditation Council for Graduate Medical Education; or
b. The Committee on Postdoctoral Training of the
American Osteopathic Association; and
(2) An additional 2 years of clinical experience
in therapeutic radiology under the supervision of an authorized user; and
(3) The following training:
a. Examining individuals;
b. Reviewing individuals’ case histories to
determine their suitability for external beam radiation therapy treatment, and
any limitations and contraindications;
c. Selecting proper dose;
d. Selecting how the dose is to be administered;
e. Calculating the external beam radiation
therapy doses;
f. Collaborating with the authorized user in the
review of patients’ progress;
g. Considering of the need to modify originally
prescribed doses and/or treatment plans as warranted by patients’ reaction to
radiation;
h. Post-administration follow-up; and
i. Post-administration review of case histories.
(i) Notwithstanding
the requirements of He-P 4047.04(e)(1) and He‑P 4047.04(e)(2), the
registrant for any therapeutic radiation machine subject to He-P 4047 shall
also submit the training of the prospective authorized user physician for
DHHS/RHS review.
(j) A physician shall not act as an authorized
user for any therapeutic radiation machine until such time as said physician’s
training has been reviewed and approved by DHHS/RHS.
(k) The registrant for any therapeutic radiation
machine subject to He-P 4047 shall require the radiation therapy physicist to
be registered with DHHS/RHS, under the provisions of He-P 4040, as a provider
of radiation services in the area of calibration and
compliance surveys of external beam radiation therapy units, and either:
(1) Be certified by:
a. The American Board of Radiology in:
1. Therapeutic radiological physics;
2. Roentgen-ray and gamma-ray physics;
3. X-ray and radium physics; or
4. Radiological physics; or
b. The American Board of Medical Physics in
Radiation Oncology Physics; or
c. The Canadian College of Medical Physics; or
(2) Alternately, the radiation therapy physicist
shall meet the following requirements:
a. Hold a master’s or doctor’s degree in
physics, medical physics, engineering, applied mathematics, biophysics,
radiological physics, or health physics from an accredited college or
university;
b. Have completed one year of full time training
in therapeutic radiological physics;
c. Have completed one year full-time work
experience under the supervision of a radiation therapy physicist at a medical
institution; and
d. The training and work experience as required
in He-P 4047.04 (2) above, shall be conducted in a clinical radiation facility
that provides high-energy external beam radiation therapy.
(l) To meet the requirement in He-P
4047.04(k)(2)c. above, the individual shall have performed the tasks listed in
He-P 4047.05(a) through (f), and He-P 4047.06(r) and (s), and He-P 4047.07(u)
and (v), under the supervision of a radiation therapy physicist during the year
of work experience.
(m) Notwithstanding the provisions of He-P
4047.04(k)(2) and (l), certification pursuant to He-P 4047.04(k)(1) shall be
required on or before December 31, 1999 for all persons currently qualifying as
a radiation therapy physicist pursuant to He-P 4047.04(k).
(n) Each individual who operates a therapeutic radiation
machine for medical use shall:
(1) Be a registered radiation therapy
technologist with the American Registry of Radiologic Technologists (ARRT); or
(2) Submit evidence that he or she has
satisfactorily completed a radiation therapy technologist training program that
complies with the requirements of the Joint Review Committee on Education in
Radiologic Technology; or
(3) Be a student working under the direct
supervision and in the physical presence of a registered radiation therapy
technologist.
(o) The names and training of all personnel
currently operating a therapeutic radiation machine shall be kept on file at
the facility.
(p) Information about former operators shall be
retained for a period of at least 2 years beyond the last date they were
authorized to operate a therapeutic radiation machine at that facility.
(q) Written safety procedures and rules shall be
developed by a radiation therapy physicist.
(r) Written safety procedures and rules shall be
available in the control area of a therapeutic radiation machine, including any
restrictions required for the safe operation of the particular
therapeutic radiation machine.
(s) The operator shall be able to demonstrate
familiarity with the procedures and rules required in He‑P 4047.04(q) and
(r).
(t) Individuals shall not be exposed to the
useful beam except for medical therapy purposes and unless such exposure has
been ordered in writing by an authorized user.
(u) The provision in He-P 4047.04(t) shall
specifically prohibit deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.
(v) Notwithstanding the provisions of He-P 4047.04(e)(1)
and (e)(2), a registrant may permit any physician to act as a visiting
authorized user under the term of the registrant’s Certificate of Registration
for up to 60 days per calendar year under the following conditions:
(1) The visiting authorized user has the prior
written permission of the registrant’s management;
(2) The use occurs on behalf of an institution,
or the institution’s Radiation Safety Committee;
(3) The visiting authorized user meets the
requirements established for authorized user(s) in He-P 4047.04(e)(1) and He-P
4047.04(e)(2); and
(4) The registrant maintains copies of all
records specified by He-P 4047.04(v) for 5 years after the records are made.
(w) All individuals associated with the operation
of a therapeutic radiation machine shall be instructed in the provisions of the
registrant’s quality management program.
(x) All individuals associated with the operation
of a therapeutic radiation machine shall comply with the provisions of the
registrant’s quality management program.
(y) All individuals associated with the operation
of a therapeutic radiation machine shall be subject to the requirements of He-P
4020 through He-P 4022.
(z) The registrant shall maintain for inspection
by DHHS/RHS the following information in a separate file or package for each
therapeutic radiation machine:
(1) Report of acceptance testing;
(2) Records of all:
a. Surveys with date(s) performed;
b. Calibrations with date(s) performed;
c. Periodic, dated, quality assurance checks of
the therapeutic radiation machine required by He-P 4047; and
d. The name(s) of person(s) who performed such
activities;
(3) Records of:
a. Maintenance, with the date(s) it was
performed;
b. Any modifications, with the date(s) the
modifications were performed on the therapeutic radiation machine; and
c. The name(s) of person(s) who performed such
services; and
(4) The signature of the person authorizing the
return of therapeutic radiation machine to clinical use after service, repair,
or upgrade.
(aa) All records required by He-P 4047 shall be
retained until disposal is authorized by DHHS/RHS unless another retention
period is specifically authorized in He-P 4047.
(ab) All required records shall be retained in an
active file from at least the time of generation until the next DHHS/RHS
inspection.
(ac) Any required record generated prior to the
last DHHS/RHS inspection may be microfilmed or otherwise archived as long as a
complete copy of said record can be retrieved until such time as DHHS/RHS
authorizes final disposal.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.05 General Technical Requirements for
Facilities Using Therapeutic Radiation Machines.
(a) The registrant shall ensure that radiation protection
surveys of all new facilities, and existing facilities not previously surveyed,
are performed with an operable radiation measurement survey instrument
calibrated in accordance with He-P 4047.08.
(b) The radiation protection survey shall be
performed by, or under the direction of, a radiation therapy physicist or a
qualified expert.
(c) The radiation protection survey shall verify
that, with the therapeutic radiation machine in a “BEAM-ON” condition, with the
largest clinically available treatment field and with a scattering phantom in
the useful beam of radiation, the following requirements are met:
(1) Radiation levels in restricted areas are not
likely to cause personnel exposures in excess of the
limits specified in He-P 4020.05; and
(2) Radiation levels in unrestricted areas do not
exceed the limits specified in He-P 4020.13(a) and (b).
(d) In addition to the requirements of He-P
4047.05(a), a radiation protection survey shall also be performed prior to any
subsequent medical use; and:
(1) After making any change in the treatment room
shielding;
(2) After making any change in the location of
the therapeutic radiation machine within the treatment room;
(3) After relocating the therapeutic radiation
machine to a different treatment room; or
(4) Before using the therapeutic radiation
machine in a manner that could result in increased radiation levels in areas
outside the external radiation therapy treatment room.
(e) The survey record required in He-P 4047.05(d)
shall include:
(1) All instances where the facility is in
violation of applicable rules;
(2) The date of the measurements;
(3) The reason for the survey;
(4) The manufacturer’s name;
(5) Model number of the therapeutic radiation
machine;
(6) Serial number of the therapeutic radiation
machine;
(7) The instrument(s) used to measure radiation
levels;
(8) A diagram of the areas surrounding the
treatment room that were surveyed;
(9) The measured dose rate at several points in
each area expressed in microsieverts or millirems per
hour;
(10) The calculated maximum level of radiation
over a period of 1 week for each restricted and unrestricted area; and
(11) The signature of the individual responsible
for conducting the survey.
(f) If the results of the surveys required by
He-P 4047.05(a) and (d) indicate any radiation levels in excess of the
respective limit specified in He-P 4020, the registrant shall lock the control
in the “OFF” position and not use the unit except as may be necessary to
repair, replace, or test the therapeutic radiation machine, test the
therapeutic radiation machine shielding, or test the treatment room shielding.
(g) If the survey required by He-P 4047.05(a) and
(d) indicates that an individual in an unrestricted area may be exposed to
levels of radiation greater than those permitted by He-P 4020.13(a) and (b),
before beginning the treatment program the registrant shall:
(1) Equip the unit with beam direction interlocks
or add additional radiation shielding to ensure compliance with He-P 4020.13(a)
and (b);
(2) Perform the survey required by He-P
4047.05(a) again; and
(3) Include in the record required by He-P
4047.05(e):
a. The results of the initial survey;
b. A description of the modification made to
comply with He-P 4047.05(g)(1); and
c. The results of the second survey.
(h) The registrant shall have a dosimetry system
available for use which has been calibrated by the National Institute for
Standards and Technology (NIST) or by an American Association of Physicists in
Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL) as follows:
(1) For beams with energies greater than 1 MV (1
MeV), the dosimetry system shall have been calibrated for Cobalt-60; and
(2) For beams with energies equal to or less than
1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy or
for an energy range appropriate for the radiation being measured.
(i) The calibration
of the dosimetry system required in He-P 4047.05(h) shall have been performed
within the previous 24 months, and after any servicing that may have affected
system calibration.
(j) An independent survey shall be conducted by a
radiation therapy physicist or qualified expert other than the person
performing the original survey prior to the system being used except as
described in He-P 4047.05(f).
(k) The registrant shall have available for use a
dosimetry system for quality assurance check measurements. To meet this requirement, the system shall be
compared with a system that has been calibrated in accordance with He-P
4047.05(h) through (j). This comparison
shall have been performed within the previous 12 months, and after each
servicing that may have affected system calibration. The quality assurance check system shall be
the same system used to meet the requirements in He-P 4047.05(h) through (j).
(l) The registrant shall maintain a record of each
dosimetry system calibration, intercomparison, and comparison for each
therapeutic radiation machine.
(m) For each calibration, intercomparison, or
comparison, the record shall include:
(1) The date;
(2) The model numbers of the instruments that
were calibrated;
(3) The serial numbers of the instruments that
were calibrated, intercompared, compared, or used to meet the requirements in
He-P 4047.05(h) through (k);
(4) The correction factors that were determined;
(5) The names of
the individuals who performed the calibration, intercomparison, or comparison;
and
(6) Evidence that the intercomparison was
performed by, or under the direct supervision and in the physical presence of,
a radiation therapy physicist.
(n) The registrant for any therapeutic radiation
machine shall be able to furnish a copy of the records required in He-P 4047.05
to DHHS/RHS upon request, within 30 days following completion of the action
that initiated the record requirement.
(o) Each registrant using radiation therapy
machines shall establish and maintain a quality management program to provide
high confidence that radiation will be administered as directed by the
authorized user.
(p) The registrant shall make modifications to
the quality management program to increase the program’s efficiency.
(q) The quality management program required by
He-P 4047.05(o) shall include written policies and procedures to meet the
following specific objectives:
(1) Prior to administration, a written directive
shall be prepared for any external beam radiation therapy dose;
(2) Notwithstanding He-P 4047.05(q)(1) above, a
written revision to an existing written directive shall be acceptable provided
that the revision is dated and signed by an authorized user prior to
administration of the external beam radiation therapy dose or the next external
beam radiation therapy fractional dose;
(3) If, because of the patient’s condition, a
delay in order to provide a written revision to an
existing written directive would jeopardize the patient’s health, an oral
revision to an existing written directive shall be acceptable, provided that
the oral revision is documented immediately in the patient’s record and a
revised written directive is signed by an authorized user within 48 hours of
the oral revision;
(4) The written directive shall contain the
patient or human research subject’s name, the type and energy of the beam, the
total dose, dose per fraction, treatment site and number of fractions;
(5) A written revision to an existing written
directive shall be made provided that the revision is dated and signed by an
authorized user prior to the administration of the therapeutic radiation
machine dose, or the next fractional dose; and
(6) The registrant shall retain a copy of each
written directive for 3 years.
(r) The registrant shall develop, implement and maintain written procedures to provide high
confidence that:
(1) Prior to the administration of each course of
radiation treatment, the patient's identity is verified, by more than one
method, as the individual named in the written directive;
(2) Each administration is in accordance with the
written directive;
(3) The therapeutic radiation machine final
treatment plans and related calculations are in accordance with the respective
written directives by:
a. Checking both
manual and computer generated dose calculations to verify they are correct and
in accordance with the written directive; and
b. Verifying that
any computer generated calculations are correctly transferred into consoles of
authorized therapeutic medical units;
(4) Any unintended deviation from the written
directive is identified and evaluated, and appropriate action is taken; and
(5) The registrant retains a copy of the
procedures for administrations for the duration of the registration.
(s) Each registrant using radiation therapy
equipment shall have a quality management program that specifies staff, staff
duties and responsibilities, equipment, and procedures.
(t) Each existing registrant shall submit to
DHHS/RHS a copy of the written quality management program that has been
implemented.
(u) The registrant shall include as a part of the
quality management program the following:
(1) An evaluation of a representative sample of
patient administrations and a review of all recordable events, and all misadministrations, if any, to verify compliance with all
aspects of the quality management program;
(2) Reviews conducted at intervals not to exceed
12 months;
(3) An evaluation of each review to determine the
effectiveness of the quality management program and, if necessary to make
modifications to meet the requirements of these rules; and
(4) Records of each review, including the
evaluations and findings of the review, which shall be retained for 3 years.
(v) Each registrant shall report any event
resulting from intervention of a patient or human research subject in which the
administration of therapeutic radiation machine results, or will result in,
unintended permanent functional damage to an organ or a physiological system as
determined by a physician.
(w) Other than events that result from
intervention by a patient or human research subject each registrant shall
report any event in which the administration of a therapeutic radiation machine
therapy dose:
(1) Involved the wrong patient, wrong treatment
modality or wrong treatment site; or
(2) The calculated weekly administered dose
differing from the weekly prescribed dose by more than 30 percent; or
(3) The calculated total administered dose
differing from the total prescribed dose by more than 20 percent of the total
prescribed dose.
(x) The registrant shall evaluate and respond,
within 30 days after discovery of a recordable event, by:
(1) Assembling the relevant facts including the
cause;
(2) Identifying what, if any, corrective action
is required to prevent recurrence; and
(3) Retaining a record, for 3 years, of the
relevant facts, and the corrective action, if any, which was taken.
(y) The registrant shall evaluate each
misadministration.
(z) The registrant shall take the following
actions in response to a misadministration:
(1) Notify DHHS/RHS by telephone no later than
the next business day after discovery of the misadministration;
(2) Submit a written report to
DHHS/RHS within 15 days after discovery of the misadministration including:
a. The registrant’s name;
b. The prescribing physician’s name;
c. A brief description of the event;
d. Why the event occurred;
e. The effect on the patient;
f. What improvements are needed to prevent
recurrence;
g. Actions taken to prevent recurrence;
h. Whether the
registrant notified the patient or the patient’s responsible relative or
guardian; and
i. What information was provided to the patient;
but
j. Shall not include the patient’s name or other
information that could lead to identification of the patient;
(3) Notify the referring physician;
(4) Notify the patient of the misadministration
no later than 24 hours after its discovery, unless the referring physician
personally informs the registrant either that he/she will inform the patient or
that, based on medical judgment, telling the patient would be harmful;
(5) Notify the patient as soon as possible
thereafter if the referring physician or patient cannot be reached within 24
hours;
(6) Not delay any appropriate medical care for
the patient, including any necessary remedial care as a
result of the misadministration, because of any delay in notification;
(7) If a verbal notification is made, the
registrant shall inform the patient, or appropriate responsible relative or
guardian, that a written description of the event can be obtained from the
registrant upon request. The registrant
shall provide such a written description if requested; and
(8) Retain a record of each misadministration for
3 years, including:
a. The names of all individuals involved;
b. The patient’s Social Security number or other
identification number;
c. A brief description of the event;
d. Why it occurred and the effect on the
patient;
e. What improvements are needed to prevent
recurrence;
f. The actions taken to prevent recurrence; and
g. Whether the patient was notified or not.
(aa) Aside from the notification requirements in
(z) above, nothing in this section shall affect any rights or duties of
registrants and physicians in relation to each other, to the patient affected
by the event, or to that patient’s responsible relative or guardian.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15, ss by #10894, eff 7-21-15
He-P 4047.06 Therapeutic Radiation Machines of Less
Than 500 kV.
(a) When the x-ray tube is operated at its maximum
rated tube current for the maximum kV, the leakage air kerma
rate shall not exceed the value specified at the distance specified as follows:
(1) For 5 to 50 kV systems, the leakage air kerma rate measured at any position 5 centimeters from the
tube housing assembly shall not exceed 1 mGy (100 mrad) in any one-hour period;
(2) For >50 and <500 kV systems:
a. The leakage air kerma
rate measured at a distance of 1 meter from the target in any direction shall
not exceed 1 cGy (1 rad) in any one-hour
period;
b. This air kerma rate
measurement may be averaged over areas no larger than 100 square centimeters;
and
c. The air kerma rate
at a distance of 5 centimeters from the surface of the
tube housing assembly shall not exceed 30 cGy (30
rad) per hour;
(3) For each therapeutic radiation machine, the
registrant shall determine, or obtain from the manufacturer, the leakage
radiation existing at the positions specified in He‑P 4047.06(a)(1) and
(a)(2), for the specified operating conditions; and
(4) Records on leakage radiation measurements
shall be maintained after installation for inspection by DHHS/RHS.
(b) Permanent diaphragms or cones used for
limiting the useful beam shall provide at least the same degree of attenuation
as required for the tube housing assembly.
(c) All adjustable or removable beam limiting
devices, diaphragms, cones or blocks shall meet the
following requirements:
(1) None shall transmit more than 5 percent of
the useful beam for the most penetrating beam used; and
(2) When adjustable or removable beam limiting
devices are used, the position and shape of the radiation field shall be
indicated by a light beam.
(d) The filter system shall be so designed that:
(1) Filters can not be
accidentally displaced at any possible tube orientation;
(2) An interlock system prevents irradiation if
the proper filter is not in place;
(3) The air kerma rate
escaping from the filter slot shall not exceed 1 cGy
(1 rad) per hour at one meter under any operating conditions; and
(4) Each filter shall be marked as to its
material of construction and its thickness.
(e) The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect to the
housing aperture.
(f) The tube housing assembly shall be capable of
being immobilized for stationary portal treatments.
(g) The tube housing assembly shall be marked so
that:
(1) It is possible to determine the location of
the source to within 5 millimeters; and
(2) Such marking shall be readily accessible for
use during calibration procedures.
(h) Contact therapy tube housing assemblies shall
have a removable shield of material, equivalent in attenuation to 0.5
millimeters of lead at 100 kV, which can be positioned over the entire useful
beam exit port during periods when the beam is not in use.
(i) A timer control
device shall be provided to terminate the irradiation after a pre-set time
interval and shall:
(1) Have a display;
(2) Be provided at the treatment control;
(3) Have a pre-set time selector;
(4) Have elapsed time or time remaining
indicator;
(5) Be a cumulative timer which activates with an
indication of “BEAM-ON” and retains its reading after irradiation is
interrupted or terminated;
(6) Be able to reset the elapsed time indicator
after irradiation is terminated and before irradiation can be re-initiated;
(7) Terminate irradiation when a pre-selected
time has elapsed, if any dose monitoring system present has not previously
terminated irradiation;
(8) Permit accurate pre-setting and determination
of exposure times as short as 1 second;
(9) Not permit an exposure if set at zero;
(10) Not activate
until the shutter is opened when irradiation is controlled by a shutter
mechanism unless calibration includes a timer error correction to compensate
for mechanical lag; and
(11) Be accurate to within 1 percent of the
selected value or 1 second, whichever is greater.
(j) The control panel, in addition to the
displays required by other provisions in He-P 4047.06, shall have:
(1) An indication of whether electrical power is
available at the control panel and if activation of the x-ray tube is possible;
(2) An indication of whether x-rays are being
produced;
(3) Means for indicating x-ray tube potential and
current;
(4) Means for terminating exposure at any time;
(5) A locking device which will prevent unauthorized
use of the therapeutic radiation machine; and
(6) A positive display of specific filter(s) in
the beam.
(k) A control panel which may energize more than
one x-ray tube shall:
(1) Activate only one x-ray tube at any time;
(2) Have an indication at the control panel
identifying which x-ray tube is activated; and
(3) Have an indication at the tube housing
assembly when that tube is energized.
(l) There shall be a means of determining the central
axis target-to-skin distance to within 1 centimeter and of reproducing this
measurement to within 2 millimeters thereafter.
(m) Shutters shall be required as follows:
(1) Unless it is possible to bring the x-ray
output to the prescribed exposure parameters within 5 seconds after the x-ray
“ON” switch is energized, the beam shall be attenuated by a shutter having a
lead equivalency not less than that of the tube housing assembly;
(2) After the unit is at operating parameters,
the shutter shall be controlled by the operator from the control panel; and
(3) An indication of shutter position shall
appear at the control panel.
(n) Each therapeutic radiation machine equipped
with a beryllium or other low-filtration window shall:
(1) Be clearly labeled as such on the tube
housing assembly; and
(2) Be provided with a permanent warning device
on the control panel that is activated when there is no additional filtration
present, in order to indicate that the dose rate is
very high.
(o) In addition to the shielding requirements of
He-P 4047, the treatment room shall meet the following facility design
requirements for therapeutic radiation machines capable of operating in the
range 50 kV to 500 kV:
(1) Provision shall be made for continuous
two-way aural communication between the patient and the operator at the control
panel; and
(2) A viewing system shall:
a. Be provided to permit continuous observation
of the patient during irradiation;
b. Enable the operator to observe the patient
from the control panel; and
c. Be operational for use of therapeutic
radiation machine for patient irradiation.
(p) Treatment rooms which contain a therapeutic
radiation machine capable of operating above 150 kV shall meet the following
additional requirements:
(1) All protective barriers shall be fixed except
for entrance doors or beam interceptors;
(2) The control panel shall be located outside
the treatment room or in a totally enclosed booth, which has a shielded
ceiling, inside the room;
(3) Interlocks shall be provided such that all
entrance doors, including doors to any interior booths, shall be closed before
treatment can be initiated or continued;
(4) If the radiation beam is interrupted by any
door opening, it shall not be possible to restore the machine to operation
without closing the door and re-initiating irradiation by manual action at the
control panel; and
(5) When any door referred to in
He-P 4047.06(p) is opened while the x-ray tube is activated, the air kerma rate at a distance of 1 meter from the source shall
be reduced to less than 1 mGy (100 mrad) per hour.
(q) Full calibration of a therapeutic radiation
machine shall be performed by, or under the direct supervision of, a radiation
therapy physicist and shall meet the following requirements:
(1) Full calibration shall be performed as
follows:
a. Before the first medical use following
installation or reinstallation of the therapeutic radiation machine;
b. At intervals not exceeding 1 year; and
c. Before medical use under the following
conditions:
1. Whenever quality assurance check measurements
indicate that the radiation output differs by more than 5 percent from the
value obtained at the last full calibration and the differences cannot be
reconciled; and
2. Following any
component replacement, major repair, or modification of components that could
significantly affect the characteristics of the radiation beam;
(2) Notwithstanding the requirements of He-P
4047.06(q)(1) c.1. above:
a. Full calibration of therapeutic radiation
machines with multi-energy capabilities is required only for those modes and/or
energies that are not within their acceptable range;
b. If the repair, replacement, or modification
does not affect all energies, full calibration shall be performed on the
affected energy that is in most frequent clinical use at the facility; and
c. Any remaining energies may be validated with
quality assurance check procedures against the criteria in He-P 4047.06(q)(1)
c.1;
(3) For machines with energies greater than or
equal to 10 KeV and less than or equal to 40 KeV full calibration shall include
all measurements recommended for annual calibration by National Council on
Radiation Protection (NCRP) Report 69, “Dosimetry of X-ray and Gamma Ray Beams
for Radiation Therapy in the Energy Range 10 KeV to 50 MeV” (1981), which is
incorporated by reference and included in Appendix A. For machines with energies greater than or
equal to 40 kV and less than equal to 300 kV, full calibration shall include
all measurements recommended for annual calibration by “High Dose-Rate
Brachytherapy Treatment Delivery” (1998), AAPM Task Group 59, and “AAPM
Protocol for 40-300 kV X-Ray Beam Dosimetry in Radiotherapy and Radiobiology”
(2001) by AAPM Task Group 61, both of which are incorporated by reference and
included in Appendix A;
(4) The registrant shall maintain a record of
each calibration for the duration of the registration; and
(5) The calibration record shall include:
a. The date of the calibration;
b. The manufacturer’s
name, model number, and serial number for both the therapeutic machine and the
x-ray tube;
c. The model
numbers and serial numbers of the instruments used to calibrate the therapeutic
radiation machine; and
d. The signature
of the radiation therapy physicist responsible for performing the calibration.
(r) Periodic quality assurance checks shall be
performed on therapeutic radiation machines subject to He-P 4047.06, which are
capable of operation at greater than or equal to 50 kV, as follows:
(1) The registrant shall perform quality
assurance checks specified in He-P 4047.06(r) in accordance with written
procedures established by the radiation therapy physicist;
(2) The quality assurance check procedures
required by He-P 4047.06(r)(1) shall specify:
a. The frequency at which tests or measurements
are to be performed;
b. That the quality assurance check be performed
during the calibration specified in He-P 4047.06(q); and
c. The acceptable tolerance for each parameter
measured in the quality assurance check, when compared to the value for that
parameter determined in the calibration as specified by He-P 4047.06(q)(1);
(3) The quality assurance check shall investigate
the cause for a parameter exceeding a tolerance set by the radiation therapy
physicist and correct such parameter before the system is used for patient
irradiation;
(4) Whenever a quality assurance check indicates
a significant change in the operating characteristics of a system, as specified
in the radiation therapy physicist’s quality assurance check procedures, the
system shall be recalibrated as specified by He-P 4047.06(q)(1);
(5) The registrant shall use the dosimetry system
described in He-P 4047.05(k) to make the quality assurance check required in
He-P 4047.06(r)(2);
(6) The registrant shall have the radiation
therapy physicist review and sign the results of each radiation output quality
assurance check within 30 days of the date that the check was performed;
(7) The registrant shall ensure that the safety quality
assurance checks of therapeutic radiation machines are performed at intervals
not to exceed 30 days;
(8) The registrant shall ensure that no
therapeutic machine is used to administer radiation to humans unless the
quality assurance checks will have been performed within the 30-day period
immediately prior to said administration;
(9) Safety quality assurance checks shall ensure
proper operation of:
a. Electrical interlocks at each external beam
radiation therapy room entrance;
b. Proper operation of the “BEAM-ON” and
termination switches;
c. Beam condition
indicator lights on the access door(s), control console, and in the radiation
therapy room;
d. Viewing systems; and
e. If applicable,
electrically operated treatment room doors from inside and outside the
treatment room;
(10) The registrant shall maintain a record of
each quality assurance check for 3 years; and
(11) The quality assurance check records shall
include:
a. The date of the quality assurance check;
b. The manufacturer’s name, model number, and
serial number for the therapeutic radiation machine;
c. The manufacturer’s name, model number, and serial
number of the instrument(s) used to measure the radiation output of the
therapeutic radiation machine; and
d. The signature of the individual who performed
the periodic quality assurance check.
(s) The following operating procedures shall be
met:
(1) The therapeutic radiation machine shall not
be used for irradiation of patients unless the requirements of He-P 4047.06(q)
and He-P 4047.06(r) have been met;
(2) Therapeutic radiation machines shall not be
left unattended unless secured pursuant to He-P 4047.06(j)(5);
(3) When a patient must be held in position for
radiation therapy, mechanical supporting or restraining devices shall be used;
(4) The tube housing assembly shall not be held
by an individual during operation unless the assembly is designed to require
such holding and the peak tube potential of the system does not exceed 50 kV;
(5) If the tube housing is held, the holder shall
wear protective gloves and apron of not less than 0.5 millimeters lead
equivalency at 100 kV;
(6) A copy of the
current operating and emergency procedures shall be maintained at the
therapeutic radiation machine control console;
(7) No individual other than the patient shall be
in the treatment room during exposures from therapeutic radiation machines
operating above 150 kV; and
(8) At energies
less than or equal to 150 kV, any individual, other than the patient, in the
treatment room shall be protected by a barrier sufficient to meet the
requirements of He-P 4020.
(t) Each facility location authorized to use a
therapeutic radiation machine in accordance with He-P 4047.06 shall:
(1) Possess appropriately calibrated portable
monitoring equipment;
(2) As a minimum, include a portable radiation
measurement survey instrument capable of measuring dose rates over the range of
10 μSv (1 mrem) per hour to 10 mSv (1000 mrem)
per hour; and
(3) Require the survey instrument(s) to be
operable and calibrated in accordance with He-P 4047.08.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.07 Therapeutic Radiation Machines - Photon
Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and
Above).
(a) Each facility location authorized to use a
therapeutic radiation machine in accordance with He‑P 4047.07 shall
possess, operable and calibrated in accordance with He-P 4047.08, portable
monitoring equipment to include as a minimum a portable radiation measurement
survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour.
(b) Leakage radiation outside the maximum useful
beam in photon and electron modes shall meet the following requirements:
(1) The absorbed dose due to leakage radiation
(excluding neutrons) at any point outside the maximum sized useful beam, but
within a circular plane of radius 2 meters which is perpendicular to and
centered on the central axis of the useful beam at the nominal treatment
distance or patient plane, shall not exceed a maximum of 0.2 percent and an
average of 0.1 percent of the absorbed dose on the central axis of the beam at
the nominal treatment distance when measurements are averaged over an area not
exceeding 100 square centimeters at a minimum of 16 points uniformly
distributed in the plane;
(2) Except for the area defined in He-P
4047.07(b)(1), the absorbed dose due to leakage radiation (excluding neutrons)
at 1 meter from the electron path between the electron source and the target or
electron window shall not exceed 0.5 percent of the absorbed dose on the
central axis of the beam at the nominal treatment distance when measurements
are averaged over an area not exceeding 100 square centimeters;
(3) The neutron absorbed dose outside the useful
beam shall be in compliance with International
Electrotechnical Commission (IEC) Document 60601-2-1, as amended, which is
incorporated by reference and included in Appendix A;
(4) For each therapeutic radiation machine, the registrant
shall determine, or obtain from the manufacturer, the leakage radiation
existing at the positions specified in He-P 4047.07(b)(1)-(3) for the specified
operating conditions; and
(5) Records on leakage radiation measurements
shall be maintained after installation for inspection by DHHS/RHS.
(c) Leakage radiation through beam limiting
devices shall be as follows:
(1) For photon radiation, all adjustable or
interchangeable beam limiting devices shall attenuate the useful beam such that
at the nominal treatment distance, the maximum absorbed dose anywhere in the
area shielded by the beam limiting device(s) shall not exceed 5 percent of the
maximum absorbed dose on the central axis of the useful beam measured in a 100
square centimeter radiation field or maximum available field size if less than
100 square centimeters;
(2) For electron radiation, all adjustable or
interchangeable electron applicators shall attenuate the radiation, including
but not limited to photon radiation generated by electrons incident on the beam
limiting device and electron applicator and other parts of the radiation head,
such that the absorbed dose in a plane perpendicular to the central axis of the
useful beam at the nominal treatment distance shall not exceed:
a. For points beyond a line 7 centimeters
outside the periphery of the useful beam, a maximum limit of 2 percent and
average of 0.5 percent of the absorbed dose on the central axis of the useful
beam at the nominal treatment distance; and
b. For points beyond a line 2 centimeters up to
7 centimeters outside the periphery of the useful beam, a maximum limit of 10
percent of the absorbed dose on the central axis of the useful beam at the
nominal treatment distance;
(3) Measurements of leakage radiation through the
beam limiting for photon radiation devices shall be:
a. Made with the beam limiting devices closed;
b. Made with any residual
aperture blocked by at least 2 tenth value layers of suitable absorbing
material;
c. Measured independently at the depth of
maximum dose for each set of overlapping beam limiting
device; and
d. The depth of
maximum dose made using a radiation detector of area not exceeding 10 square
centimeters;
(4) Measurements of leakage radiation through the
electron applicators shall:
a. Be made with the electron beam directed into
the air;
b. Use a radiation detector of area up to but
not exceeding 1 square centimeter suitably protected against radiation which
has been scattered from material beyond the radiation detector; and
c. Be made using one centimeter of water
equivalent build up material; and
(5) Leakage radiation through beam limiting
devices shall be determined for photon radiation and for electron radiation in
radiation therapy machines which operate in both modes.
(d) Filters and wedges used in therapeutic
radiation machines shall meet the following requirements:
(1) Each wedge filter which is removable from the
system shall be clearly marked with an identification number;
(2) Each removable wedge filter shall have the nominal
wedge angle appear on the wedge or wedge tray if permanently mounted to the
tray;
(3) If the wedge or wedge tray is significantly
damaged, the wedge transmission factor shall be redetermined;
(4) If the absorbed dose rate information
required by He-P 4047.07(i)
relates exclusively to operation with a field flattening filter or beam
scattering foil in place, such foil or filter shall be removable only by the
use of tools; and
(5) For equipment which utilizes a system of
wedge filters, interchangeable field flattening filters, or interchangeable
beam scattering foils:
a. Irradiation shall not be possible until a
selection of a filter or a positive selection to use “no filter” has been made
at the treatment control panel, either manually or automatically;
b. An interlock system shall be provided to
prevent irradiation if the filter selected is not in the correct position;
c. A display shall be provided at the treatment control
panel showing the wedge filter(s), interchangeable field flattening filter(s),
and/or interchangeable beam scattering foil(s) in use; and
d. An interlock shall be provided to prevent
irradiation if any filter and/or beam scattering foil selection operation
carried out in the treatment room does not agree with the filter and/or beam
scattering foil selection operation carried out at the treatment control panel.
(e) The registrant shall determine during
acceptance testing, or obtain from the manufacturer, data sufficient to ensure
that X ray stray radiation in the useful electron beam, absorbed dose at the
surface during X‑ray irradiation and stray neutron radiation in the
useful X-ray beam are in compliance with International
Electrotechnical Commission (IEC) Document 60601-2-1 which is incorporated by
reference and included in Appendix A.
(f) All therapeutic radiation machines subject to
He-P 4047.07 shall meet the following requirements:
(1) All therapeutic radiation machines shall be
provided with:
a. Redundant beam monitoring systems which have
sensors fixed in the useful beam during treatment to indicate the dose monitor
unit rate;
b. At least 2 independently powered integrating
dose meters if manufactured after July 1, 1998; and
c. At least one radiation detector incorporated
into a useful beam monitoring system, if manufactured before July 1, 1998; and
(2) The detector and the system into which that
detector is incorporated shall meet the following requirements:
a. Each detector shall be removable only with
tools;
b. If the detector is movable, it shall be
interlocked to prevent incorrect positioning;
c. Each detector shall form part of a beam
monitoring system from whose readings in dose monitor units the absorbed dose
at a reference point can be calculated;
d. Each beam
monitoring system shall be capable of independently monitoring, interrupting,
and terminating irradiation;
e. The design of the beam monitoring systems
shall ensure that the:
1. Malfunctioning of one system shall not affect
the correct functioning of the other system(s); and
2. Failure of either system shall terminate
irradiation or prevent the initiation of radiation; and
f. Each beam monitoring system shall have a
legible display at the treatment control panel which shall:
1. Maintain a reading until intentionally reset;
2. Have only one scale and no electrical or
mechanical scale multiplying factors;
3. Utilize a design such that increasing dose is
displayed by increasing numbers; and
4. In the event of power failure, the beam
monitoring information displayed at the control panel at the time of failure
shall be retrievable in at least one system for a 20-minute period
of time.
(g) Bent-beam linear accelerators shall be
provided with auxiliary device(s) to monitor beam symmetry which:
(1) Shall be able to detect field asymmetry
greater than 10 percent; and
(2) Shall be configured to terminate irradiation
if the specifications above cannot be maintained.
(h) Selection and display of dose monitor units
shall be as follows:
(1) Irradiation shall not be possible until a new
selection of a number of dose monitor units has been
made at the treatment control panel;
(2) The pre-selected number of dose monitor units
shall be displayed at the treatment control panel until reset manually for the
next irradiation;
(3) After termination of irradiation, it shall be
necessary to reset the dosimeter display before subsequent treatment can be
initiated; and
(4) After termination of irradiation, it shall be
necessary for the operator to reset the pre-selected dose monitor units before
irradiation can be initiated.
(i) A system shall be
provided from whose readings the air kerma rate or
absorbed dose rate a reference point can be calculated, and which meets the
following requirements:
(1) The dose monitor unit rate shall be displayed
at the treatment control panel;
(2) If the equipment can deliver under any
conditions an air kerma rate or absorbed dose rate at
the nominal treatment distance more than twice the maximum value specified by
the manufacturer, a device shall be provided which terminates irradiation when
the air kerma rate or absorbed dose rate exceeds a
value twice the specified maximum;
(3) The dose rate at which the irradiation will
be terminated shall be a record maintained by the registrant;
(4) If the equipment can deliver under any fault
condition(s) an air kerma rate or absorbed dose rate
at the nominal treatment distance more than 10 times the maximum value
specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation
field from exceeding twice the specified maximum value and to terminate
irradiation if the excess absorbed dose at the nominal treatment distance
exceeds 4 Gy (400 rad);
(5) For each therapeutic radiation machine, the
registrant shall determine, or obtain from the manufacturer, the maximum
value(s) for the specified operating conditions; and
(6) Records of maximum value(s) shall be maintained
at the installation for inspection by DHHS/RHS.
(j) Termination of irradiation by the beam
monitoring system or systems during stationary beam radiation therapy shall be
as follows:
(1) Each primary system shall terminate
irradiation when the pre-selected number of dose monitor units has been
detected by the system;
(2) If the original design of the equipment
includes a secondary dose monitoring system, that system shall be capable of
terminating irradiation when not more than 15 percent or 40 dose monitor units,
above the pre-selected number of dose monitor units, set at the control panel,
has been detected by the secondary dose monitoring system; and
(3) An indicator on the control panel shall show
which monitoring system has terminated radiation.
(k) It shall be possible to terminate irradiation
and equipment movement or go from an interruption condition to termination
condition at any time from the operator’s position at the treatment control
panel.
(l) If a therapeutic radiation machine has an
interrupt mode:
(1) It shall be possible to interrupt irradiation
and equipment movements at any time from the treatment control panel;
(2) Following an interruption it shall be
possible to restart irradiation by operator action without any re-selection of
operating conditions; and
(3) If any change
is made of a pre-selected value during an interruption, irradiation and
equipment movements shall be automatically terminated.
(m) A suitable irradiation control device shall
be provided to terminate the irradiation after a pre-set time interval as
follows:
(1) A timer shall be provided which has a display
at the treatment control panel;
(2) The time provided shall have a pre-set time
selector and an elapsed time indicator;
(3) The timer shall be a cumulative timer which
activates with an indication of “BEAM-ON” and retains its reading after
irradiation is interrupted or terminated;
(4) After irradiation is terminated and before
irradiation can be re-initiated, it shall be necessary to reset the elapsed
time indicator; and
(5) The timer shall terminate irradiation when a
pre-selected time has elapsed, if the dose monitoring
systems have not previously terminated irradiation.
(n) Equipment capable of both x‑ray therapy
and electron therapy shall meet the following additional requirements:
(1) Irradiation shall not be possible until a
selection of radiation type (x-rays or electrons) has been made at the
treatment control panel;
(2) The radiation type selected shall be
displayed at the treatment control panel before and during irradiation;
(3) An interlock system shall be provided to
ensure that the equipment can principally emit only the radiation type which
has been selected;
(4) An interlock system shall be provided to
prevent irradiation with x-rays, except to obtain an image, when electron
applicators are fitted;
(5) An interlock system shall be provided to
prevent irradiation with electrons when accessories specific for x-ray therapy
are fitted; and
(6) An interlock system shall be provided to
prevent irradiation if any selected operations carried out in the treatment
room do not agree with the selected operations carried out at the treatment
control panel.
(o) Equipment capable of generating radiation
beams of different energies shall meet the following requirements:
(1) Irradiation shall not be possible until a
selection of energy has been made at the treatment control panel;
(2) The nominal energy value selected shall be
displayed at the treatment control panel until reset manually for the next
irradiation;
(3) After termination of irradiation, it shall be
necessary to reset the nominal energy value selected before subsequent
treatment can be initiated;
(4) Irradiation shall not be possible until the
appropriate flattening filter or scattering foil for the selected energy is in
its proper location; and
(5) The selection
of energy shall be in compliance with International
Electrotechnical Commission (IEC) Document 60601-2-1, which is incorporated by
reference and included in Appendix A.
(p) Therapeutic radiation machines capable of
both stationary beam radiation therapy and moving beam radiation therapy shall
meet the following requirements:
(1) Irradiation shall not be possible until a
selection of stationary beam radiation therapy or moving beam radiation therapy
has been made at the treatment control panel;
(2) The mode of operation shall be displayed at
the treatment control panel;
(3) An interlock system shall be provided to ensure
that the equipment can operate only in the mode which has been selected;
(4) An interlock system shall be provided to
prevent irradiation if any selected parameter in the treatment room does not
agree with the selected parameter at the treatment control panel;
(5) Moving beam irradiation therapy shall be
controlled to obtain the selected relationships between incremental dose
monitor units and incremental movement as follows:
a. An interlock system shall be provided to
terminate irradiation if the number of dose monitor units delivered in any 10
degrees of rotation or one cm of linear
motion differs by more than 20 percent from the selected value;
b. Where angle terminates the irradiation in
moving beam radiation therapy, the dose monitor units delivered shall differ by
less than 5 percent from the dose monitor unit value selected;
c. An interlock shall be provided to prevent
motion of more than 5 degrees or 1 cm beyond the selected limits during moving
beam radiation therapy;
d. An interlock shall be provided to require
that a selection of direction be made at the treatment control panel in all
units which are capable of both clockwise and counter-clockwise moving beam
radiation therapy; and
e. Moving beam radiation therapy shall be
controlled with both primary position sensors and secondary position sensors to
obtain the selected relationships between incremental dose monitor units and
incremental movement;
(6) Where the beam monitor system terminates the
irradiation in moving beam radiation therapy, the termination of irradiation
shall be as required by He-P 4047.07(j); and
(7) An interlock system shall be provided to
terminate irradiation if movement:
a. Occurs during stationary beam radiation
therapy; or
b. Does not start or stops during moving beam
radiation therapy unless stoppage is a pre-planned function.
(q) In addition to shielding adequate to meet
requirements of He-P 4047.09, the following design requirements are made for
therapeutic radiation machines operating above 500 kV:
(1) All protective barriers shall be fixed,
except for access doors to the treatment room or movable beam interceptors;
(2) The control panel shall:
a. Be located outside the treatment room;
b. Provide an indication of whether electrical
power is available at the control panel and if activation of the radiation is
possible;
c. Provide an indication or whether radiation is
being produced; and
d. Include an access control (locking) device
which will prevent unauthorized use of the therapeutic radiation machine;
(3) Windows, mirrors, closed-circuit television,
or an equivalent viewing system shall be provided to permit continuous
observation of the patient following positioning and during irradiation and
shall be so located that the operator may observe the patient from the
treatment control panel;
(4) The therapeutic radiation machine shall not
be used for patient irradiation unless at least one viewing system is
operational;
(5) Provision shall be made for continuous
two-way aural communication between the patient and the operator at the control
panel;
(6) The
therapeutic radiation machine shall not be used for irradiation of patients
unless continuous two-way aural communication is possible;
(7) Treatment room
entrances shall be provided with warning lights in a readily observable
position near the outside of all access doors, which will indicate when the
useful beam is “ON” and when it is “OFF”;
(8) Interlocks shall be provided such that all
access controls are activated before treatment can be initiated or continued;
(9) If the radiation beam is interrupted by any
access control, it shall not be possible to restore the machine to operation
without resetting the access control and re-initiating irradiation by manual
action at the control panel;
(10) If the shielding material in any protective barrier
requires the presence of a beam interceptor to ensure compliance with He‑P4020.13,
interlocks shall be provided to prevent the production of radiation, unless the
beam interceptor is in place, whenever the useful beam is directed at the
designated barrier(s);
(11) At least one emergency power cutoff switch in
addition to the termination switch shall be located in
the radiation therapy room and shall terminate all equipment electrical power
including radiation and mechanical motion;
(12) All emergency power cutoff switches shall
include a manual reset so that the therapeutic radiation machine cannot be
restarted from the unit’s control console without resetting the emergency
cutoff switch;
(13) All safety interlocks shall be designed so
that any defect or component failure in the safety interlock system prevents or
terminates operation of the therapeutic radiation machine; and
(14) Surveys for residual activity shall be
conducted on all therapeutic radiation machines capable of generating photon
and electron energies above 10 MV prior to machining, removing, or working on
therapeutic radiation machine components which may have become activated due to
photo-neutron production.
(r) The services of the radiation therapy
physicist shall be required in facilities having therapeutic radiation machines
with energies of 500 kV and above.
(s) The radiation therapy physicist required in
He-P 4047.07(r) shall be responsible for:
(1) Full calibration(s) required by He-P
4047.07(u);
(2) Protection surveys required by He-P 4047.05;
(3) Supervision and review of dosimetry;
(4) Beam data acquisition and transfer for
computerized dosimetry and supervision of its use;
(5) Quality assurance, including quality
assurance check review required by He‑P 4047.07(v)(6);
(6) Consultation with the authorized user in
treatment planning, as needed; and
(7) Performing calculation and assessments
regarding misadministrations.
(t) The following operating procedures shall be
required:
(1) If the radiation therapy physicist is not a
full-time employee of the registrant, the operating procedures shall
specifically address how the radiation therapy physicist is to be contacted for
problems or emergencies, as well as the specific actions, if any, to be taken
until the radiation therapy physicist can be contacted;
(2) No individual, other than the patient, shall be
in the treatment room during treatment or during any irradiation for testing or
calibration purposes;
(3) Therapeutic
radiation machines shall not be made available for medical use unless the
requirements of He-P 4047.05 and He-P 4047.07(u) and (v) have been met;
(4) Therapeutic
radiation machines, when not in operation, shall be secured to prevent
unauthorized use;
(5) When adjustable beam limiting devices are
used, the position and shape of the radiation field shall be indicated by a
light field;
(6) If a patient must be held in position during
treatment, mechanical supporting or restraining devices shall be used; and
(7) A copy of the
current operating and emergency procedures shall be maintained at the
therapeutic radiation machine control console.
(u) Acceptance testing, commissioning, and full
calibration measurements shall be as follows:
(1) Acceptance testing, commissioning, and full
calibration of a therapeutic radiation machine shall be performed by, or under
the direct supervision of, a radiation therapy physicist;
(2) Acceptance testing and commissioning shall be
performed in accordance with “AAPM Code of Practice for Radiotherapy
Accelerators” (1994) prepared by AAPM Radiation Therapy Task Group 45, which is
incorporated by reference and included in Appendix A, and the manufacturer’s
contractual specifications;
(3) Acceptance testing and commissioning shall be
conducted before the first medical use following installation or reinstallation
of the therapeutic radiation machine;
(4) Full calibration shall include measurement of
all parameters required by Table II of “Comprehensive QA for Radiation
Oncology” (1994) prepared by AAPM Radiation Therapy Committee Task Group 40,
which Report and Table are incorporated by reference and included in Appendix
A;
(5) Full calibration shall be performed in
accordance with “AAPM Code of Practice for Radiotherapy Accelerators” (1994) prepared
by AAPM Radiation Therapy Task Group 45 which is incorporated by reference and
included in Appendix A;
(6) It shall not be necessary to complete all
elements of a full calibration at the same time, all applicable parameters (for
all energies) shall be completed at intervals not exceeding 12 calendar months,
unless a more frequent interval is required in Table II of “Comprehensive QA
for Radiation Oncology” (1994) prepared by AAPM Radiation Therapy Committee
Task Group 40, which is incorporated by reference and included in Appendix A;
(7) The radiation therapy physicist shall perform
all elements of a full calibration necessary to determine that all parameters
are within acceptable limits as follows:
a. Whenever quality assurance check measurements
indicate that the radiation output differs by more than 5 percent from the
value obtained at the last full calibration and the difference cannot be
reconciled;
b. Therapeutic radiation machines with
multi-energy and/or multi-mode capabilities shall only require measurements for
those modes and/or energies that are not within their acceptable range;
c. Following any component replacement, major
repair, or modification of components that could significantly affect the
characteristics of the radiation beam;
d. If the repair, replacement, or modification
does not affect all modes and/or energies, measurements shall be performed on
the effected mode/energy that is in most frequent clinical use at the facility;
and
e. The remaining
energies/modes may be validated with quality assurance check procedures against
the criteria in He-P 4047.07(u)(7);
(8) The registrant shall use the dosimetry system
described in He-P 4047.05(h) and (i) to measure the
radiation output for one set of exposure conditions;
(9) The remaining radiation measurements required
in He-P 4047.07(u)(2)-(6) may be made using a dosimetry system that indicates
relative dose rates;
(10) The registrant shall maintain a record of
each calibration in an auditable form for the life of the therapeutic radiation
machine; and
(11) The record required in He-P 4047.07(u)(10)
shall include:
a. The date of the calibration;
b. The manufacturer’s name;
c. Model number of the therapeutic machine;
d. Serial number of the therapeutic machine;
e. The model
numbers and serial numbers of the instruments used to calibrate the therapeutic
radiation machine; and
f. The signature
of the radiation therapy physicist responsible for performing the calibration.
(v) Periodic quality assurance checks shall meet
the following requirements:
(1) Periodic quality assurance checks shall be
performed on all therapeutic radiation machines subject to He-P 4047.07 at
intervals not to exceed those specified in “Comprehensive QA for Radiation
Oncology” (1994), prepared by AAPM Radiation Therapy Committee Task Group 40,
which is incorporated by reference and included in Appendix A;
(2) Quality assurance checks shall include determination
of central axis radiation output and a representative sampling of periodic
quality assurance checks contained in “Comprehensive QA for Radiation Oncology”
(1994) prepared by AAPM Radiation Therapy Committee Task Group 40 which is
incorporated by reference and included in Appendix A;
(3) Representative sampling as required in He-P
4047.07(v)(2) shall include all referenced periodic quality assurance checks in
an interval not to exceed 12 consecutive calendar months;
(4) The registrant shall use a dosimetry system
which has been intercompared within the previous 12 months with the dosimetry
system described in He-P 4047.05(h) and (i) to make
the periodic quality assurance checks;
(5) The registrant shall perform periodic quality
assurance checks in accordance with procedures established by the radiation
therapy physicist;
(6) The registrant shall review the results of
each periodic radiation output check according to the following procedures:
a. The authorized user and radiation therapy
physicist shall be immediately notified if any parameter is not within its
acceptable tolerance;
b. The therapeutic radiation machine shall not
be made available for subsequent medical use until the radiation therapy
physicist has determined that all parameters are within their acceptable
tolerances;
c. If all quality assurance check parameters
appear to be within their acceptable range, the quality assurance check shall
be reviewed and signed by either the authorized user or radiation therapy
physicist within 3 treatment days; and
d. The radiation therapy physicist shall review
and sign the results of each radiation output quality assurance check at
intervals not exceed 30 days;
(7) Therapeutic radiation machines subject to
He-P 4047.07 shall have safety quality assurance checks listed in
“Comprehensive QA for Radiation Oncology” (1994) prepared by AAPM Radiation
Therapy Committee Task Group 40, which is incorporated by reference and
included in Appendix A, performed at intervals not to exceed 7 days;
(8) To satisfy the requirement of He-P
4047.07(v)(7), safety quality assurance checks shall ensure proper operation
of:
a. Electrical interlocks at each external beam
radiation therapy room entrance;
b. The “BEAM-ON”, interrupt, and termination
switches;
c. Beam condition indicator lights on the access
doors, control console, and in the radiation therapy room;
d. Viewing systems;
e. Electrically operated treatment room door(s)
from inside and outside the treatment room; and
f. At least one emergency power cutoff switch,
as follows:
1. If more than one emergency power cutoff
switch is installed and not all switches are tested at once, each switch shall
be tested on a rotating basis; and
2. Safety quality assurance checks of the
emergency power cutoff switches may be conducted at the end of the treatment
day in order to minimize possible stability problems
with the therapeutic radiation machine.
(9) The registrant shall promptly repair any
system identified in He-P 4047.07(v)(8) that is not operating properly;
(10) The registrant shall maintain a record of
each quality assurance check required for 3 years; and
(11) The record required in He-P 4047.07(v)(10)
shall include:
a. The date of the quality assurance check;
b. The manufacturer’s name;
c. The machine model number;
d. The machine serial number;
e. The manufacturer’s name, model number, and
serial number of the instrument(s) used to measure the radiation output of the
therapeutic radiation machine; and
f. The signature of the individual who performed
the periodic quality assurance check.
(w) For intensity modulated radiation therapy
(IMRT), quality assurance checks shall:
(1) Include commissioning and testing of the
treatment planning and delivery systems, routine quality assurance of the
delivery system, and patient specific validation of treatment plan;
(2) Be performed in accordance with “Guidance
document on delivery, treatment planning, and clinical implementation of IMRT”
(2003) Report of the IMRT subcommittee of the AAPM radiation therapy committee: AAPM Report No. 82, which is incorporated by
reference and included in Appendix A;
(3) Be performed in accordance with the
manufacturer’s contractual specifications.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.08 Calibration of Survey Instruments.
(a) The registrant shall ensure that the survey
instruments used to show compliance with He-P 4047 have been calibrated as
follows:
(1) Before the first use;
(2) At intervals not to exceed 12 months; and
(3) Following repair.
(b) To satisfy the requirements of He-P
4047.08(a), the registrant shall:
(1) Calibrate all required scale readings up to
10 mSv (1000 mrem) per hour with an appropriate radiation source that is traceable
to the National Institute of Standards and Technology (NIST); and
(2) Calibrate at least 2 points on each scale to
be calibrated. These points shall be
approximately 1/3 to 2/3 full-scale.
(c) To satisfy the requirements of He-P
4047.08(b), the registrant shall:
(1) Consider a point as calibrated if the
indicated dose rate differs from the calculated dose rate by not more than 10
percent; and
(2) Consider a point as calibrated if the
indicated dose rate differs from the calculated dose rate by not more than 20
percent if a correction factor or graph is conspicuously attached to the
instrument.
(d) The registrant shall retain a record of each
calibration required in He-P 4047.08(a) for 3 years.
(e) The record required in He-P 4047.08(d) shall
include:
(1) A description of the calibration procedure;
and
(2) A description of:
a. The source used;
b. The certified dose rates from the source;
c. The rates indicated by the instrument being
calibrated;
d. The correction factors deduced from the
calibration data;
e. The signature of the individual who performed
the calibration; and
f. The date of calibration.
(f) The registrant may obtain the services of
individuals registered or licensed by DHHS/RHS, the U.S. Nuclear Regulatory
Commission, an Agreement State, or a Licensing State to perform calibrations of
survey instruments.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.09 Shielding and Safety Design Requirements.
(a) Each therapeutic radiation machine subject to
He-P 4047.06 or He-P 4047.07 shall be provided with such primary and secondary
barriers as are necessary to ensure compliance with He-P 4020.05 and He-P
4020.13.
(b) Facility design information for all new
installations of a therapeutic radiation machine or installations of a
therapeutic radiation machine of higher energy into a room not previously
approved for that energy shall be submitted for DHHS/RHS approval prior to
actual installation of the therapeutic radiation machine.
(c) The following minimum facility design
information shall be submitted to DHHS/RHS with any request for the therapeutic
radiation machine installation approval:
(1) For any therapeutic radiation machine, the
following basic facility information:
a. Name;
b. Telephone number;
c. The DHHS/RHS registration number of the
individual responsible for preparation of the shielding plan;
d. Name and telephone number of the facility
supervisor;
e. The facility street address;
f. The facility room number for the therapeutic
radiation machine;
g. Indication if this is a new structure or a
modification to existing structure(s);
h. The primary barriers for all wall, floor, and
ceiling areas struck by the useful beam;
i. All secondary barriers provided in all wall, floor, and ceiling areas not having primary barriers;
j. If commercial software is used to generate
shielding requirements, the software name, version, and date of revision;
k. If the software used to generate shielding
requirements is not in the open literature, quality control sample calculations
to verify the result obtained with the software;
l. The structural composition and thickness or
lead equivalent of all walls, doors, partitions, floor, and ceiling of the
room(s) concerned;
m. The type of occupancy of all adjacent areas
inclusive of space above and below the room(s) concerned, and any exterior
wall(s), with distance to the closest area(s) where it is likely that
individuals may be present; and
n. At least one example calculation which shows
the methodology used to determine the amount of shielding required for each
primary and secondary/leakage barriers, restricted and unrestricted areas,
entry door(s), and shielding material in the facility.
(2) In addition to the requirements listed in
He-P 4047.09(c)(1), therapeutic radiation machine facilities which produce only
photons with a maximum energy less than or equal to 150 kV shall submit
shielding plans which contain, as a minimum, the following additional
information:
a. Equipment
specifications, including the manufacturer and model number of the therapeutic
radiation machine, as well as the maximum technique factors;
b. Maximum design workload for the facility to
include:
1. Total weekly radiation output expressed in
gray (rad) or air kerma at 1 meter;
2. Total beam-on time per day or week;
3. The average treatment time per patient; and
4. The anticipated number of patients to be
treated per day or week; and
c. A facility blueprint/drawing indicating:
1. Scale;
2. Direction of North;
3. Normal location of the therapeutic radiation
machine’s radiation port(s);
4. The port’s travel and traverse limits;
5. General direction(s) of the useful beam;
6. Locations of any windows and doors;
7. The location of the therapeutic radiation
machine control panel;
8. The location of the operator’s booth if the
control panel is located inside the therapeutic radiation machine treatment
room; and
9. The operator’s station at the control panel
has a protective barrier sufficient to ensure compliance with He-P 4020.05;
(3) In addition to the requirements listed in
He-P 4047.09(c)(1), therapeutic radiation machine facilities that produce
photons with a maximum energy in excess of 150 kV or
electrons shall submit shielding plans which contain, as a minimum, the
following additional information:
a. Equipment specifications to include:
1. The manufacturer;
2. The model number of the therapeutic radiation
machine;
3. The gray or rad at the isocenter;
4. The energy(s) and type(s) of radiation
produced; and
5. The target to isocenter distance;
b. Maximum design workload for the facility
including:
1. Total weekly radiation output expressed in
gray rad at 1 meter;
2. Total beam-on time per day or week;
3. The average treatment time per patient; and
4. The anticipated number of patients to be
treated per day or week;
c. Facility blueprint or drawing indicating:
1. The floor plan
and elevation views each indicating relative orientation of the therapeutic
radiation machine;
2. Type(s), thickness, and minimum density of
shielding material(s);
3. Direction of North; and
4. The locations and size of all beam penetrations
through each ceiling, wall, floor, details of the door(s) and maze shielding
barrier; and
d. A description of all assumptions that were in
the shielding calculations including, but not limited to:
1. Design energy;
2. Work-load;
3. Presence of integral beam-stop in unit;
4. Occupancy and use(s) of adjacent areas;
5. Fraction of time that useful beam will
intercept each permanent barrier for all walls, floor
and ceiling; and
6. “Allowed” radiation exposure in both
restricted and unrestricted areas.
(4) In addition to the requirements listed in
He-P 4047.09(c)(3), therapeutic radiation machine facilities which are capable of operating above 10 MV shall submit shielding
plans which contain, as minimum, the following additional information:
a. The structural composition, thickness,
minimum density, and location of all neutron shielding
material;
b. Description of all assumptions that were used
in neutron shielding calculations including, but not limited to;
1. Neutron spectra as a function of energy;
2. Neutron fluence rate; and
3. Absorbed dose and dose equivalent for
neutrons in both restricted and unrestricted areas;
c. At least one example calculation which shows
the methodology used to determine the amount of neutron shielding required for
each restricted and unrestricted areas, entry door(s), maze and the neutron
shielding material utilized in the facility; and
d. The method(s) and instrumentation which will
be used to verify the adequacy of all neutron
shielding installed in the facility.
Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff
7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff
1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15
He-P 4047.10 Quality Assurance For Radiation Therapy
Simulation Systems. Quality assurance
for a conventional or virtual simulator shall include:
(a) Acceptance testing;
(b) Periodic verification of system performance;
(c) Be performed in accordance with
“Comprehensive QA for Radiation Oncology,” (Updated by Table II)(1994) prepared
by American Association of Physicists in Medicine (AAPM), Radiation Therapy
Committee Task Group No. 40; or
(d) Be performed in accordance with “Quality
Assurance for Computed –Tomography Simulators and the Computed
Tomography-Simulation Process” (2003) prepared by AAPM Radiation Therapy
Committee Task Group 66 as incorporated by reference and included in Appendix
A.
Source. #10894, eff 7-21-15
He-P 4047.11
Electronic Brachytherapy.
(a) Electronic brachytherapy devices shall be
subject to the requirements of He-P 4047.11 and shall be exempt from the
requirements of He-P 4047.06, and which are:
(1) An electronic brachytherapy device that does
not meet the requirement of He-P 4047.11 shall not be used for irradiation of
patients; and
(2) An electronic brachytherapy device shall only
be utilized for human use applications specifically approved by the U.S. Food
and Drug Administration (FDA) unless participating in a research study approved
by the registrant’s Institutional Review Board.
(b) Each facility location authorized to use an
electronic brachytherapy device shall possess appropriately calibrated portable
monitoring equipment which shall as a minimum:
(1) Include a portable radiation measurement
survey instrument capable of measuring dose rate over the range of 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour, and
(2) Be operable and calibrated in accordance with
He-P 4047.08 for the applicable electronic brachytherapy source energy.
(c) In addition to shielding adequate to meet the
requirements of He-P 4047.09, the treatment room shall meet the following
design requirements:
(1) If applicable, provision shall be made to
prevent simultaneous operation of more than one therapeutic radiation machine
in a treatment room;
(2) Access to the treatment room shall be
controlled by a door at each entrance;
(3) Each treatment room shall have provisions to
permit continuous aural communication and visual observation of the patient
from the treatment control panel during irradiation;
(4) The electronic brachytherapy device shall not
be used for patient irradiation unless patient can be observed;
(5) For electronic brachytherapy devices capable
of operating below 50kV, radiation shielding for the staff in the room shall be
available:
a. Either as a portable shield; or
b. As localized shielded material around the
treatment site; and
(6) For electronic brachytherapy devices capable
of operating at greater than 150 kV;
a. The control panel shall be located outside
the treatment room; and
b. Electrical interlocks shall be provided for
all door(s) to the treatment room that will:
1. Prevent the operator from initiating the
treatment cycle unless each treatment room entrance door is closed;
2. Cause the source to be shielded when an
entrance door is opened; and
3. Prevent the source from being exposed
following an interlock interruption until all treatment room entrance doors are
closed and the source on-off control is reset at the console.
(d) Each electronic brachytherapy device shall
have the following electrical safety features:
(1) The high voltage transformer shall be electronically
isolated to prevent electrical and magnetic interference with the surrounding
environment and ancillary equipment;
(2) The high voltage transformer shall be
isolated from personnel and the environment by a protective housing that can
only be accessed through a cover requiring a tool for access or with electrical
interlocks to prevent operation while open;
(3) The high voltage transformer shall have
appropriate safety labels warning personnel of potential electrical shock and
or heat related injuries; and
(4) Equipment manufactured shall be in compliance with the most current revision of the
following International Electrotechnical Commission (IEC) Documents which are
incorporated by reference and included in Appendix A:
a. IEC 60601-1 1998 + A1+A2: 1995;
b. IEC 60601-1-2:2001;
c. IEC 60601-2-8: 1999; and
d. IEC 60601-2-17; 2004.
(e) The control panel in addition to the displays
required by other provisions in He-P 4047.11, shall:
(1) Provide an indication of whether electrical
power is available at the control panel and if activation of the electronic
brachytherapy source is possible;
(2) Provide an indication of whether x-rays are
being produced;
(3) Provide a means for indicating electronic
brachytherapy source potential and current;
(4) Provide the means for terminating an exposure
at any time; and
(5) Include an access control (locking) device
that will prevent unauthorized use of the electronic brachytherapy device.
(f) A suitable irradiation control device or
timer shall be provided to terminate the irradiation after a preset time
interval or integrated charge on a dosimeter-based monitor. Timers shall:
(1) Be provided at the control panel and shall
indicate planned setting and the time elapsed or remaining;
(2) Not permit an exposure if set at zero;
(3) Be a cumulative device that activates with an
indication of “BEAM On” and retains its reading after irradiation is
interrupted or terminated. After
irradiation is terminated and before irradiation can be reinstated, it shall be
necessary to reset the elapsed time indicator;
(4) Terminate irradiation when a pre-selected
time has elapsed, if any dose monitoring system has not previously terminated
irradiation;
(5) Permit setting of exposure times as short as
0.1 seconds; and
(6) Be accurate to within 1 percent of the
selected value or 0.1 seconds, whichever is greater.
(g) The services of a radiation therapy physicist
shall be required in facilities having electronic brachytherapy devices. The radiation therapy physicist shall be
responsible for:
(1) Evaluation of the output from the electronic
brachytherapy source;
(2) Generation of the necessary dosimetric information;
(3) Supervision and review of treatment
calculations prior to initial treatment of any treatment site:
(4) Establishing the periodic and day-of-use
quality assurance checks and reviewing the data from those checks as required
in He-P 4047.11(j);
(5) Consultation with the authorized user in
treatment planning, as needed;
(6) Performing calculations and assessments
regarding patient treatments that may constitute a misadministration; and
(7) Determining which persons in the treatment
room require monitoring when the beam is energized.
(h) Operating procedures shall be as follows:
(1) Only individuals approved by the authorized user,
radiation safety officer or radiation therapy physicist shall be present in the
treatment room during treatment;
(2) Electronic brachytherapy devices shall not be
made available for medical use unless the requirements of He-P 4047.04(a), and
He-P 4047.11(i) through He-P 4047.11(k) have been
met;
(3) The electronic brachytherapy device shall be
secured to prevent unauthorized use;
(4) During operation, the electronic
brachytherapy device operator shall monitor the position of all persons in the
treatment room, and all persons entering the treatment room, to prevent
entering persons from unshielded exposure from the treatment beam;
(5) If a patient must be held in position during
treatment, mechanical supporting or restraining devices shall be used;
(6) Written procedures shall be developed,
implemented, and maintained for responding to an abnormal situation. These procedures shall include:
a. Instructions
for responding to equipment failures and the names of the individuals
responsible for implementing corrective actions; and
b. The names and telephone numbers of the
authorized users, radiation safety officer and the radiation therapy physicist
to be contacted if the device or console operates abnormally;
(7) A copy of the current operating and emergency
procedures shall be maintained at the control console or panel during
electronic brachytherapy device operation.
If the console is integral to the electronic brachytherapy device, the required procedures shall be
kept where the operator is located during electronic brachytherapy device
operation;
(8) Instructions shall be posted at the
electronic brachytherapy device control console to inform the operator of the
names and telephone numbers of the authorized users, the radiation safety
officer, and the radiation therapy physicist to be contacted if the device or
console operates abnormally;
(9) The radiation safety officer, and an
authorized user shall be notified as soon as possible if the patient has
medical emergency, suffers injury or dies. The radiation safety officer or radiation
therapy physicist shall inform the manufacturer of the event;
(10) If the radiation therapy physicist is not a
full time employee of the registrant, the operating procedures, required in
He-P 4047.11(h) shall also specifically address how the radiation therapy
physicist is to be contacted for problems or emergencies, as well as the
specific actions, if any, to be taken until the radiation therapy physicist can
be contacted.
(i) Calibration
procedures shall include:
(1) Calibration of the electronic brachytherapy
source output shall be made for each electronic brachytherapy source, or after
any repair affecting the x-ray beam generation, or when indicated by the
electronic brachytherapy source quality assurance checks;
(2) Calibration of electronic brachytherapy
source output shall utilize a dosimetry system described in He- 4047.05(h);
(3) Calibration of electronic brachytherapy
source output shall include, as applicable, determination of:
a. The output within 2 percent of the expected
value, if applicable, or determination of the output if there is no expected
value;
b. Timer accuracy and linearity over the typical
range of use;
c. Proper operation of back exposure control
device;
d. Evaluation that the relative dose
distribution about the source is within 5 percent of that expected; and
e. Source positioning accuracy within 1
millimeter of the applicator;
(4) Calibration of the x-ray source output
required in by He-P 4047.11(i) above, shall be in
accordance with current published recommendations from a recognized national
professional association with expertise in electronic brachytherapy, and if
that published recommendation is not available, then from the manufacturer’s
suggested calibration protocol; and
(5) The registrant shall maintain a record of
each calibration in an auditable form for the duration of registration. The record shall include:
a. The date of the calibration;
b. The manufacturer’s name;
c. The model number and serial number for the
electronic brachytherapy device;
d. A unique identifier for its electronic
brachytherapy source;
e. The model
numbers and serial numbers of the instrument(s) used to calibrate the
electronic brachytherapy device; and
f. The name and signature of the radiation
therapy physicist responsible for performing the calibration.
(j) Quality assurance checks shall be conducted
as follows:
(1) Quality assurance checks shall be performed
on each electronic brachytherapy device subject to He-P 4047.11:
a. At the beginning of each day of use;
b. Each time the device is moved to a new room
or site, intended to include each day of use at each operating location and
c. After each x-ray tube installation;
(2) The registrant shall perform periodic quality
assurance checks required by He-P 4047.11(j)(1) in accordance with procedures
established by the Radiation Therapy Physicist;
(3) To satisfy the requirements of He-P
4047.11(j)(1), radiation output quality assurance checks shall include as a
minimum:
a. Verification that output of the electronic
brachytherapy source falls within 3 percent of expected values, as appropriate
for the device, as determined by:
1. Output as a function of time; or
2. Output as a function of setting on a monitor
chamber;
b. Verification of the consistency of the dose
distribution to within 3 percent of that found during calibration required by
He-P 4047.11(i); and
c. Validation of the operation of positioning
methods to ensure that the treatment dose exposes the intended location within
one mm;
(4) The registrant shall use a dosimetry system
that has been intercompared within the previous 12 months with the dosimetry
system described in He-P 4047.05(h) to make the quality assurance checks
required in He-P 4047.11(j)(3);
(5) The registrant shall review the results of
each radiation output quality assurance check according to the following
procedures:
a. An authorized user and radiation therapy
physicist shall be immediately notified if any parameter is not within its
acceptable tolerance. The electronic
brachytherapy device shall not be made available for subsequent medical use
until the radiation therapy physicist has determined that all parameters are
within their acceptable tolerances;
b. If all radiation output quality assurance
check parameters appear to be within their acceptable range, the quality
assurance check shall be reviewed and signed by either the authorized user or
radiation therapy physicist within 2 business
days; and
c. The radiation therapy physicist shall review
and sign the results of each radiation output quality assurance check at
intervals not to exceed 30 days;
(6) To satisfy the requirement of He-P 4047.11(i)(1), safety device quality assurance checks shall at a
minimum assure:
a. Proper operation of radiation exposure
indicator lights on the electronic brachytherapy device and on the control
console;
b. Proper operation of viewing and intercom
systems in each electronic brachytherapy facility, if applicable;
c. Proper operation of radiation monitors, if
applicable;
d. The integrity of all cables, catheters or
parts of the device that carry high voltages; and
e. Connecting guide tubes, transfer tubes,
transfer-tube applicator interfaces, and treatment spacers are free from any
defects that interfere with proper operation;
(7) If the results of the safety device quality
assurance checks required in He-P 4047.11(j)(6) indicate the malfunction of any
system, a registrant shall secure the control console in the OFF position and
not use the electronic brachytherapy device except as might be necessary to
repair, replace, or check the malfunctioning system; and
(8) The registrant shall maintain a record of
each quality assurance check required by He-P 4047.11(j)(3) and He-P
4047.11(j)(6) in an auditable form for 3 years as follows:
a. The record shall include:
1. Date of the quality assurance check;
2. Manufacturer’s
name, model number and serial number for the electronic brachytherapy device;
3. Name and signature of the individual who
performed the periodic quality assurance check; and
4. Name and signature of the radiation therapy
physicist who reviewed the quality assurance check; and
b. For radiation output quality assurance checks
required by He-P 4047.11(j)(3), the record shall also include:
1. The unique identifier for the electronic
brachytherapy source; and
2. The manufacturer’s name, model number and
serial number for the instrument(s) used to measure the radiation output of the
electronic brachytherapy device.
(k) The registrant shall perform acceptance
testing on the treatment planning system of electronic brachytherapy-related
computer systems in accordance with current published recommendations from a
recognized national professional association with expertise in electronic
brachytherapy, when available. In the
absence of an acceptance testing protocol published by a national professional
association, the manufacturer’s acceptance testing protocol shall be
followed. All acceptance testing shall:
(1) Be performed by, or under the direct
supervision of, a radiation therapy physicist; and
(2) At a minimum, acceptance testing shall
include as applicable, verification of:
a. The source-specific input parameters required
by the dose calculation algorithm;
b. The accuracy of
dose, dwell time, and treatment time calculations at representative points;
c. The accuracy of isodose plots and graphic
displays;
d. The accuracy of the software used to
determine radiation source positions from radiographic images; and
e. If the treatment-planning system is different
from the treatment-delivery system, the accuracy of electronic transfer of the
treatment delivery parameters to the treatment delivery unit from the treatment
planning system;
(3) Compare the position indicators in the
applicator to the actual position of the
source or planned dwell positions, as appropriate, at a time of commissioning;
and
(4) Include procedures prior to each patient
treatment regimen, for the parameters for the treatment to be evaluated and
approved by the authorized user and the radiation therapy physicist for
correctness through means independent of that used for the determination of the
parameters.
(l) The following training shall be required:
(1) A registrant shall provide instruction,
initially and at least annually, to all individuals who operate the electronic
brachytherapy device, as appropriate to the individual’s assigned duties, in
the operating procedures identified in He-P 4047.11(h). If the interval between patients exceeds one
year, retraining of the individuals shall be provided;
(2) In addition to the requirements of He-P
4047.04(e) for the therapeutic radiation machine authorized users and He-P 4047.04(k)
for radiation therapy physicists, these individuals shall also receive device
specific instruction initially from the manufacturer, and annually from either
the manufacturer or other authorized manufacturer qualified trainer. The training shall be of a duration
recommended by a recognized national professional association with expertise in
electronic brachytherapy, when available.
In the absence of any training protocol recommended by a national
professional association, the manufacturer’s training protocol shall be
followed. The training shall include,
but not be limited to:
a. Device-specific radiation safety
requirements;
b. Device operation;
c. Clinical use for the types of use approved by
the FDA;
d. Emergency procedures, including an emergency
drill; and
e. The registrant’s quality assurance program;
and
(3) A registrant shall retain a record of
individuals receiving instruction required by He-P 4047.11(l)(1) and (2) for 3
years. The record shall include:
a. A list of the topics covered;
b. The date of the instruction;
c. The name(s) of the attendee(s); and
d. The name(s) of the individual(s) who provided
the instruction.
(m) A registrant providing mobile electronic
brachytherapy service shall as a minimum:
(1) Check all survey instruments before medical
use at each address of use or on each day of use, whichever is more
restrictive;
(2) Account for the electronic brachytherapy
source in the electronic brachytherapy device before departure from the
client’s address; and
(3) Perform, at each location on each day of use,
all of the required quality assurance checks specified
in He-P 4047.11(j) to assure proper operation of the device.
Source. #10894, eff 7-21-15
He-P 4047.12 Other Use of Electronically-Produced
Radiation to Deliver Therapeutic Radiation Dosage. A person shall not utilize any device which
is designed to electrically generate a source of ionizing radiation to deliver
therapeutic radiation dosage, and which is not appropriately regulated under
any existing category of therapeutic radiation machine, until:
(a) The applicant or registrant has, at a
minimum, provided DHHS/RHS with:
(1) A detailed description of the device and its
intended application(s):
(2) Facility design requirements, including
shielding and access control;
(3) Documentation of appropriate training for
authorized user physician(s) and radiation therapy physicist(s);
(4) Methodology for measurement of dosages to be administered
to patients or human research subjects;
(5) Documentation regarding calibration,
maintenance, and repair of the device, as well as instruments and equipment
necessary for radiation safety;
(6) Radiation safety precautions and
instructions; and
(7) Other information requested by DHHS/RHS in
its review of the application.
(b) The applicant or registrant has received
approval from DHHS/RHS to utilize the device in accordance with the regulations
and specific conditions DHHS/RHS considers necessary for the medical use of the
device.
Source. #10894, eff 7-21-15
PART He-P 4048 -
4061 Reserved