10 CFR Part 35, subparts F and H

Subpart F:
35.400 Use of sources for manual brachytherapy (Caitlin)
 The Sealed Source and Device Registry (SSDR) lists approved manual brachytherapy
sources and how they are to be used by a licensee. If another use is warranted, it must be
in accordance with the radiation safety conditions and limitations in the SSDR. An
Investigational Device Exemption (IDE) application must be accepted by the U.S. Food
and Drug Administration prior to using sources for researching therapeutic doses for
medical use.
35.404 Surveys after source implant and removal (Caitlin)
 Surveys are required, and records must be retained after use of permanent and temporary
implanted sources. A survey to account for all sources that have not been implanted must
be conducted immediately after permanent implant. A survey of the patient or human
research subject must be completed immediately after removing the last temporary
implanted source.
35.406 Brachytherapy sources accountability (Caitlin)
 After use in a patient or human research subject, brachytherapy sources must be stored in
a secure area. A record must be maintained by a licensee for all sources in use or storage.
35.410 Safety instruction (Caitlin)
 A licensee must provide initial and yearly safety instruction to personnel working with
brachytherapy patients or human research subjects. Records of participants shall be
retained. The instruction must include size and appearance of brachytherapy sources,
proper shielding and safe handling instructions, and patient or human research subject
visitation regulations. Instruction must also include the reporting of medical emergencies
and death to the Radiation Safety Officer, a designee, or an authorized user.
35.415 Safety precautions (Asila)
 For each patient or human research subject receiving brachytherapy, a licensee must not
quarter the person in the same room as an individual not receiving brachytherapy, visibly
post a sign that states “Radioactive Materials” and note on the door or in the person’s
chart, where and for how long visitors may stay in the person’s room.
A licensee must have the necessary emergency response equipment readily available near
each treatment room in case a source is dislodged from the patient, lodged within the
patient following removal of the source applicators.
A licensee should notify the Radiation Safety Officer, or the designee, and an authorized
 user immediately if the patient or human research subject has a medical emergency or
dies.
35.432 Calibration measurements of brachytherapy sources (Asila)
 Before the first medical use of the brachytherapy source, a licensee should determine the
source output or activity using a dosimetry system that meets all requirements of
§ 35.630(a), must determine source positioning accuracy within applicators and use
published protocols that are accepted currently by nationally recognized bodies to meet
all requirements.
Instead of the licensee making its own measurements, the licensee may use
measurements provided by the source manufacturer or by a calibration laboratory
accredited by the (AAPM) American Association of Physicists in Medicine.
A licensee must mathematically correct the outputs or activities determined in this section
for physical decay at intervals consistent with 1 percent physical decay
A licensee must retain a record of each calibration in accordance with § 35.2432.
35.433 Strontium-90 sources for ophthalmic treatments (Asila)
 Licensees who use strontium-90 for ophthalmic treatments must ensure that certain
activities as specified are performed by either an authorized medical physicist or an
individual - i) who is identified as an ophthalmic physicist with a specific medical use
license, a permit issued by the Commission or Agreement State broad scope medical use
licensee, medical use permit issued by the Commission master material licensee, or
permit issued by a Commission master material licensee broad scope medical use
permittee, ii) who holds a master’s or doctor’s degree in physics, medical physics, other
physical sciences, engineering, or applied mathematics from an accredited college or
university, iii) who has successfully completed 1 year of full-time training in medical
physics and has finished an additional year of full-time work experience under the
supervision of a medical physicist, iv) who has documented training in the creation,
modification and completion of written directives and procedures for administrations
requiring a written directive and performed the calibration measurements of
brachytherapy sources as detailed in § 35.432.
The individuals who are identified above must calculate the activity of each strontium-90
source that is used to determine the treatment times for ophthalmic treatments and the
decay must be based on the activity determined under § 35.432. The individual must
assist the licensee in developing, implementing and maintaining written procedures to
provide confidence that the administration is following the written directive. These
procedures must include how often the individual meets the requirements in this section
by observing treatments, reviewing the treatment methodology, calculating treatment
time for prescribed dose, and reviews records to verify that the administrations are in
accordance with the written directives.
Licensees must retain a record of the activity of each strontium-90 source in accordance
with § 35.2433.
35.457 Therapy-related computer systems (Asila)
 The licensee must perform acceptance testing on the treatment planning system of
therapy-related computer systems following the published protocols accepted by
nationally recognized bodies. At minimum, the acceptance testing must include: the
source-specific input parameters required by the dose calculation algorithm; the accuracy
of dose, dwell time, and treatment time calculations at representative points; the accuracy
of isodose plots and graphic displays; and the accuracy of the software used to determine
sealed source positions from radiographic images.
35.490 Training for use of manual brachytherapy sources (Bryan)
 An authorized user of manual brachytherapy source will be a physician who must meet
these credentials:
 The physician is certified by a medical specialty board recognized by the Commission or
an Agreement State. They must complete at least 3 years of approved residency training.
This will be followed by an examination which must be passed.
 Or the physician must complete a basic radionuclide handling techniques educational
program which includes 200 hours of classroom and laboratory training. The classroom
and laboratory training involves radiation physics and instrumentation, radiation
protection, the use and measurement of radioactivity, and radiation biology.
o In addition to the classroom, the physician must obtain 500 hours of supervised
work experience to understand the shipping and receiving of radioactive
materials, ensure survey meters are working sufficiently, handling of
brachytherapy sources, maintain inventory, and use emergency procedures to
control byproduct material.
 If the physician has three years of supervised clinical experience in
radiation oncology under an authorized user during their formal training
program, this may count as the 500 hours listed above. Or if the physician
has a written attestation from either an authorized preceptor or residency
program director this too may count toward the supervised work
experience.
35.491 Training for ophthalmic use of strontium-90 (Bryan)
 In order for the physician to use strontium-90 for ophthalmic radiotherapy the following
requirements must be met: 1) is an authorized user of under 10 CFR § 35.490, 2)
complete 24 hours of classroom and laboratory training specifically for the use of
strontium-90 involving radiation physics and instrumentation, radiation protection, the
use and measurement of radioactivity, and radiation biology. Also, the physician must be
supervised for the ophthalmic treatment of five patients in which they must examine,
calculate and administer the dose, and follow up and review the history of each patient.
Lastly, an authorized preceptor must attest, in writing, to the physician meets the
requirements to independently fulfill the radiation safety-related duties as an authorized
user of strontium-90 for ophthalmic use.
Subpart H:
35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma
stereotactic radiosurgery unit (Bryan)
 A licensee is required to only use sealed sources: in photon-emitting remote afterloader
units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic
doses for medical uses or for research. A license is required to have sealed sources and
units approved by the Sealed Source and Device Registry to deliver a therapeutic dose for
medical use. If these sources and units are used for research purposes, they must be in
accordance with an active Investigational Device Exemption (IDE) application accepted
by the FDA provided the requirements of 10 CFR § 35.49(a) are met.
35.604 Surveys of patients and human research subjects treated with a remote afterloader
unit (Bryan)
 A licensee will not allow a patient or human research subject to be released without
surveying the patient or human research subject as well as the remote afterloader unit.
The survey must be a portable radiation detection survey instrument. The source(s) must
be confirmed to have been removed from the patient or human research subject and
returned to the safe shielded position. Records of the survey procedure must be kept in
accordance with 10 CFR § 35.2404.
35.605 Installation, maintenance, adjustment, and repair (Janice)
 Only a person licensed by Commission or Agreement state can install, maintain, adjust,
repair (relocate or remove sealed sources) remote afterloader unit, teletherapy unit, or
gamma stereotactic radiosurgery unit. A licensee needs to keep records of what is done.
35.610 Safety procedures and instructions for remote afterloader units, teletherapy units,
and gamma stereotactic radiosurgery units (Janice)
 A licensee’s responsibilities includes controlling safety of the unit and treatment room by
restricting access, preventing dual operation, creating written procedures in case of
emergencies, and holding operational and safety training initially and annually. Unit
console instructions with procedures and names of telephone numbers of authorized
persons must be posted at the unit console.
35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units (Janice)
 A licensee needs to control access to the treatment room, provide source shielding, and
assure safe radiation levels. Patients must be continuously monitored with a viewing and
intercom system. Sources placed in the body must have a quick emergency removal.
Treatments require supervision of an authorized medical physicist or authorized user that
has been trained in operation and emergency response of unit. Radiation Safety officer,
 designee, and authorized users must be notified immediately if a patient has a medical
emergency or dies. Emergency response equipment must be available near the treatment
room in an unshielded position or lodged inside the patient after treatment is completed.
35.630 Dosimetry equipment (Brittni)
 All dosimetric equipment must be calibrated for use. Low dose-rate can be determined by
the manufacturer.
The licensee will have a calibrated dosimetry system available. Calibration of dosimetry
equipment can be done one of two ways. Either by a separate system or source traceable
to the National Institute of Standards and Technology (NIST) or a calibration lab
accredited by the American Association of Physicists in Medicine (AAPM). This
calibration needs to have been done within the previous 2 years or after servicing that
could have affected system calibration. Or the system must have been calibrated within
the previous 4 years then inter compared with another dosimetry system that meets the
first method described. The comparison calibration factor must be within 2%. Licensees
should use comparable units and sources of the same radionuclide for comparison. The
licensee will also have a dosimetry system for spot-check of output measurements, which
can be compared with a system that meets the previous requirements. This must be
performed within the previous year. The licensee will also maintain a record of each
calibration, intercomparison and comparison in accordance with 35.2630.
35.632 Full calibration measurements on teletherapy units (Brittni)
 A licensee authorized to use a teletherapy unit for medical use must perform full
calibration on each teletherapy unit prior to first medical use or under the following
conditions:
o spot-check measurements indicate output differs by more than 5% from output
obtained at last full calibration
o following source replacement or relocation of teletherapy unit
o following unit repair
o intervals not exceeding 1 year
Full calibration measurements must include:
o output within +/- 3% for range of field sizes and distances for medical use
o coincidence of radiation field and light beam localizing device
o uniformity of radiation field
o timer accuracy and linearity over range of use
o on-off error
o accuracy of distance measuring and localization devices
Licensee must use dosimetry system as described in 35.630(a) to measure output for one
set of exposure conditions. The licensee will also complete any necessary mathematical
 corrections for calibration, performed by an authorized medical physicist. Retain records
for each calibration in accordance with 35.2632
35.633 Full calibration measurements on remote afterloader units (Brittni)
 A licensee authorized for medical use with a remote afterloader must perform a full
calibration on each unit prior to first medical use or under the following conditions:
o following source replacement or relocation of unit outside facility
o following unit repair
o intervals not exceeding 1 quarter for high/medium/pulsed dose-rate whose source
half-life exceeds 75 days
o Intervals not exceeding 1 year for low dose-rate
Full calibration measurements completed with a dosimetry system as described in 35.630
must include:
o output within +/- 5% and source positioning within +/- 1 mm
o source retraction with backup battery upon power failure
o length of source transfer tubes and applicators
o timer accuracy and linearity over range of use
o function of source transfer tubes, applicators, and transfer tube-applicator
interfaces
For low dose-rate licensee will also perform autoradiograph of sources verifying
inventory and source arrangement at intervals not exceeding 1 year. Measurements of
low dose-rate sources provided by source manufacturer may be used. Mathematical
corrections may be required for physical decay intervals consistent with 1 percent
physical decay, performed by an authorized medical physicist. Retain records for each
calibration in accordance with 35.2632.
35.635 Full calibration measurements on gamma stereotactic radiosurgery units (Lia)
The authorized licensee must perform full calibration measurements on each gamma
stereotactic radiosurgery unit before the following instances:
o The first medical use
o When spot checks indicate the output differs by more than 5%
o After replacing the source or reinstallation
o After any repair that may require reassembly or removal of certain parts
o At 1-year intervals and following any damage to the helmet
Full calibration measurements must include:
o Output within + 3%
o Isocenter coincidence
o Timer accuracy,
o Relative helmet factors
 o On-off error, treatment table mechanisms
o Helmet microswitches
o Emergency control
o Localization
These standards and protocols are set by nationally recognized bodies. These corrections
must be performed by the authorized medical physicist and record each calibration.
35.642 Periodic spot-checks for teletherapy units (Lia)
A licensee authorized to use teletherapy units for medical purposes must complete output
spot-checks on each unit once a month. These teletherapy spot-checks include:
o On-off error
o Timer accuracy
o Accuracy of localization devices
o Output for operating conditions
These spot-checks must follow the written procedures from the authorized medical
physicist. The results must be reviewed by the physicist within 15 days. These checks
ensure the proper operation of:
o Electrical interlocks at the room entrance
o Electrical or mechanical stops installed for limiting the beam of radiation
o Viewing and intercom systems
o Treatment room doors
Results indicating any malfunction requires a lock on the control console in the off
position and it will remain unused until any repairs are made, or the malfunction is
checked.
35.643 Periodic spot-checks for remote afterloader units (Lia)
Spot checks are required to be performed on remote afterloader units in accordance with
written procedures established by an authorized medical physicist. A medical physicist is
not required to be present for a spot check but must review the results within 15 days.
Each spot check must be recorded. Spot checks are required before the first use of a high,
medium, and pulsed dose-rate remote afterloader unit each day. Spot checks are required
before each patient treatment for low dose-rate remote afterloader units and after each
source installation.
In order to satisfy the requirements of a periodic spot check, these spot checks ensure the
proper operation of:
o Electrical interlocks at each remote afterloader unit room entrance
o Source exposure indicator lights on the remote afterloader unit, on the control
console, and in the facility
 o Emergency response equipment
o Radiation monitors used to indicate the source position
o Timer accuracy
o Clock in the unit’s computer
o The decayed source(s) activity in the unit’s computer
If a spot check indicates a malfunction, the unit shall not be used until the necessary
correction is made.
35.645 Periodic spot-checks for gamma stereotactic radiosurgery units (Rob)
 Periodic spot checks for gamma stereotactic radiosurgery units are performed at each
facility on each unit:
o Monthly
o Before First use of the unit on a given day
o After each source installation

Results of these spot checks are done in accordance with written procedures established
by the Medical Physicist, and each spot-check must be evaluated within 15 days by a
Medical Physicist. Spot checks assure the proper operation of:
o Treatment table retraction mechanism
o Using backup battery power or hydraulic backups with unit off
o Helmet microswitches
o Emergency timing circuits
o Stereotactic frames and localizing devices (trunnions)

Spot checks are also required to determine:

o Output for one typical set of operating conditions measured with the dosimetry
system
o The difference between the measurement and the anticipated output expressed as
a percentage of the anticipated output
o Source output against computer calculation
o Timer accuracy and linearity over the range of use
o On-Off Error
o Trunnion Centricity
If any systems identified in this section are not operating properly, repairs should be
arranged as soon as possible. If the results of the check indicate a malfunction of any
system, the control console should be locked in the off position except as is necessary for
repair, replace, or checking the malfunctioning system. A record of each check should be
retained, and a copy of the procedures should be kept.
35.647 Additional technical requirements for mobile remote afterloader units (Rob)
  Additional technical requirements for mobile remote afterloader units must be:
o Checked survey instruments before medical use at each address of use or on each
day of use, whichever is more frequent
o Account for all sources before departure from a client’s address of use
When checks are made, they are made to verify the operation of:
o Electrical interlocks on treatment area access points
o Source exposure indicator lights on the remote afterloader unit, on the control
console, and in the facility
o Viewing and intercom systems
o Applicators, source transfer tubes, and transfer tube-applicator interfaces
o Radiation monitors used to indicate room exposures
o Source positioning (accuracy)
o Radiation monitors used to indicate whether the source has returned to a safe
shielded position
Licensee is responsible for ensuring the overall proper operation of the remote afterloader
unit by conducting a simulated cycle of treatment before use at each address of use. If
results indicate malfunction of any system, the control console shall be locked in the off
position and not used except as necessary to repair, replace, or check the malfunctioning
system. Records of each check must be retained.
35.652 Radiation Surveys (Rob)
 Under this subpart, the licensee shall make surveys to ensure that the maximum radiation
levels and average radiation levels from the surface of the main source safe with the
source(s) in the shielded position do not exceed the levels stated in the Sealed Source and
Device Registry.
Installation of a new source and/or following repairs to the source(s) shielding, the
source(s) driving unit, or other electronic or mechanical component that could expose the
source, reduce the shielding around the source(s), or compromise the radiation safety of
the unit or the source(s).
A record of the radiation survey is required to be retained.

35.655 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units
(Eric)
 A licensee must ensure that during a source replacement the proper functioning of the
source exposure mechanism and other safety components are inspected and serviced on
gamma stereotactic radiosurgery units and teletherapy units. Gamma stereotactic
radiosurgery units should have a full inspection every 7 years and teletherapy units every
5 years. For these regular inspections and servicing, a licensed person by the Commission
or an Agreement State must carry them out. Also, a record of the inspection and servicing
must be kept in accordance with §35.2655 by a licensee.
35.657 Therapy-related computer systems (Eric)
 When a licensee gets a treatment planning system, they should perform acceptance
testing using published protocols by a nationally recognized body. The testing should
include source-specific input parameters required by the dose calculation algorithm,
accuracy of isodose plots, graphic displays, dwell time, and treatment time calculations at
representative points. Also, the software used to determine sealed source positions from
radiographic images as well as electronic transfer of the delivery parameters to the
treatment delivery unit from the treatment planning system should be tested for accuracy.
35.690 Training for use of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units (Eric)
 An authorized user of a sealed source for use authorized under § 35.600, except as
provided in § 35.57, should be a physician who meets certain criteria. They should be
certified by a medical specialty board whose process is recognized by the Commission or
an Agreement state. All candidates are required for certification to:

o Complete at least 3 years of residency training in a radiation therapy program

approved by one of these three:
 Residency Review Committee of the Accreditation Council for Graduate
Medical Education
 Royal College of Physicians and Surgeons of Canada
 Council on Postdoctoral Training of the American Osteopathic
Association

o Pass an examination by a specialty board or complete an educational program.

The program required should include:
 200 hours of classroom and laboratory training in the following areas:
 Radiation physics and instrumentation
 Radiation protection
 Mathematics pertaining to the use and measurement of
radioactivity
 Radiation biology
 500 hours of work experience supervised by an authorized user involving:
 Reviewing full calibration measurements and periodic spot-checks
 Preparing treatment plans and calculating treatment doses and
times
 Using administrative controls to prevent a medical event involving
the use of byproduct material
  Implementing emergency procedures to be followed in the event of
the abnormal operation of the medical unit or console
 Checking and using survey meters
 Selecting the proper dose and how it is to be administered

o Has completed 3 years of supervised clinical experience in radiation therapy

under an authorized user. This clinical requirement can be done concurrently with
the supervised work experience stated above.

o Has obtained written attestation from a preceptor authorized user of therapeutic

medical units the individual is requesting authorized user status for or a director
of a residency program director in which the program has a faculty member as an
authorized user and agrees with the attestation.