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10 CFR Part 35 – Subpart F & H

Subpart F
35.400 Use of sources for manual brachytherapy (summarized by Jenna Cimmiyotti)
This section highlights the appropriate use of sources for manual brachytherapy. A licensee must
only use sources that are listed as approved in the sealed source and device registry. If a source is
used for things not explicitly listed in the Sealed Source and Device Registry, its use must
conform to the radiation safety conditions and limitations described in that registry. A source can
also be used for research purposes with an accepted Investigational Device Exemption (IDE)
application that is approved by the U.S. Food and Drug Administration.
35.404 Surveys after source implant and removal (summarized by Jenna Cimmiyotti)
Surveys must be completed at the following time points:
 Immediately following implanting the sources, a survey must be completed to locate and
account for all sources that were not implanted.
 For temporary implanted sources, the licensee must survey the patient or human research
subject immediately following removal of the sources to ensure all sources have indeed
been removed from the patient or human research subject.
A record of these surveys must be kept for 3 years and include the date, survey results, the
survey instrument that was used, and the name of the individual who performed the survey.
35.406 Brachytherapy sources accountability (summarized by Jenna Cimmiyotti)
The licensee must always keep track of all the sources. This includes when they are in use and in
storage. The sources must be returned into a secure storage area as soon as possible following
removal from the patient or human research subject. The licensee must keep a record of the
sources for 3 years.
Records for temporary implants must include:
 The number and activity of sources removed from/returned to storage
 The date and time the sources were removed from/returned to storage
 The name of the individual who removed them from/returned them to storage and the
location of use
Records for permanent implants must include:
 The number, activity of sources, and date they removed from storage
 The name of the individual who removed them from storage
 The number and activity of storage not implanted, date and the name of the person who
returned them to storage
 The number and activity of sources permanently implanted in the patient or human
research subject
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35.410 Safety instruction (summarized by Jenna Cimmiyotti)

This section highlights the requirements of radiation safety instruction provided by the licensee.
The licensee must maintain a record of individuals who have received this instruction. Safety
instruction must be held initially and at least annually to all personnel who care for individuals
who have received brachytherapy and can’t be released due to potential exposure to other
individuals. Content of the radiation safety instruction must include the size and appearance of
the sources, safe handling and shielding instructions and patient and human research subject
control. Instruction should also cover visitation control including routine visitation in accordance
with the dose limits for individual members of the public as well as authorized visitations.
Finally, the licensee must notify the Radiation Safety Officer and an authorized user if the patient
or human research subject has a medical emergency or dies.
35.415 Safety precautions (summarized by Jenna Cimmiyotti)
This section highlights the safety precautions the licensee must take for each patient or human
research subject receiving brachytherapy and can’t be released due to potential exposure to other
individuals. The individual must not share a room with another individual who has not received
brachytherapy, a “Radioactive Materials” sign must be posted, and a notice regarding a time
limit and where visitors may be in the room. Appropriate emergency equipment shall be readily
available to each treatment room in the event a source is dislodged from the patient or lodged in
the patient following removed of the source applicators. The Radiation Safety Officer and an
authorized user must be notified by the licensee if there is a medical emergency or death of the
patient or human research subject.
35.432 Calibration measurements of brachytherapy sources. (Summarized by Jessica
Pagan)
This section talks about the requirements of calibration measurements for brachytherapy sources
used on or after October 24, 2002. Prior to the use of the source, it must be determined its output
or activity by using a dosimetry system that meets the requirements specified in § 35.630(a), and
they should be corrected for physical decay. The source positioning accuracy within the
applicators must also be determined. All documentation for each calibration should be recorded
and retain according to § 35.2432. A source by which manufacturers are accredited by the
American Association of Physicists in Medicine (AAPM) or calibration laboratory provided
measurements are considered acceptable.
35.433 Strontium-90 sources for ophthalmic treatments. (Summarized by Jessica Pagan)
This section discusses the decay of Sr-90 sources for ophthalmic treatments. It states that only an
authorized medical physicist can complete the calculations of the activity of the source for all
ophthalmic treatments. In addition, these calculations should be completed in accordance with
section 35.432. A record of the activity measurements should be maintained as per section
35.2433.
35.457 Therapy-related computer systems. (Summarized by Jessica Pagan)
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This section states that acceptance testing on treatment planning systems should be performed in
accordance with published protocols by nationally recognized bodies. This should include
source-specific input parameters, the accuracy of dose, dwell time, and treatment time
calculations, the accuracy of isodose displays, and the accuracy of software to determine sealed
source positions on radiographs.
35.490 Training for use of manual brachytherapy sources. (Summarized by Jessica Pagan)
This section states the requirements for physicians who want to use manual brachytherapy
sources. The required credentials are the following:
 The physicians must be certified by a medical specialty board recognized by the
commission or an Agreement State.
 Have completed a minimum of 3 years of residency training in an accredited radiation
oncology program. The education program must include 200 hours of class and lab
training in: radiation physics, radiation protection, calculations for radioactivity, and
radiation biology
 Have passed an examination administered by diplomates of the specialty board.
 The physician also must have 500 hours of work experience under an authorized user
performing: safe handling of materials and radiation surveys, implanting and removing
brachytherapy sources, taking inventory of materials.
 In addition, written attestation stating that the physician has completed all necessary
education to be authorized for the use of manual brachytherapy sources is needed.
35.491 Training for ophthalmic use of strontium-90. (Summarized by Jessica Pagan)
This section states the criteria to be an authorized user of strontium-90 for ophthalmic
radiotherapy. The physician should: have completed 24 hours of classroom and laboratory
training for the medical use of strontium-90 for ophthalmic radiotherapy. The clinical training
must include five clinical competencies with the candidate physician examining each patient,
calculating the dose, administering the dose, and providing follow-up for each case. In addition,
a written attestation signed by a preceptor authorized user who meets the requirements in CFR
35.57, 35.490, 35.491 is needed stating that the physician has completed all the requirements.

Subpart H
35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma
stereotactic radiosurgery unit. (Summarized by Hoi Wai Chau)
A licensee can only use sealed sources in photon emitting remote afterloader, teletherapy units,
or gamma stereotactic radiosurgery units. The sealed sources used in the above radiation therapy
equipment may only be used for therapeutic or research purposes. The sealed sources and the
units used in therapeutic medicine must be approved by and in accordance with the Sealed
Source and Device Registry. In the use of research purposes, the sealed sources and devices can
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only be used as described in an active Investigational Device Exemption, IDE, application,

which must be FDA approved in accordance with 10 CFR 35.49.
35.604 Surveys of patients and human research subjects treated with a remote afterloader
unit. (Summarized by Hoi Wai Chau)
A patient or research subject, who received brachytherapy treatment using a remote afterloader
unit, must be surveyed by the licensee before being released. Both the patient or the subject and
the remote afterloader unit must be surveyed. The licensee must confirm that the source has been
removed from the patient or the human research subject and it has safely returned to the safe
shielded position in the device. The licensee must keep a record of the survey as per 10 CFR
35.2404 requirements. This record must be stored for 3 years and must include the date, the
name of the surveying personnel, the surveying instrument of use, and the result of the survey.
35.605 Installation, maintenance, adjustment, and repair. (Summarized by Hoi Wai Chau)
Only persons licensed by the Commission, or an Agreement State are allowed to perform
installations, maintenance, adjustments, or repairs on sealed source devices such as remote
afterloader units, teletherapy units, or gamma stereotactic radiosurgery units. The licensed
personnel can perform work regarding source shielding, source driving unit, or other electronic
or mechanical component to ensure radiation safety is not compromised due to exposed source.
Any installation, replacement, relocation, or removal of a sealed source from the above medical
device must be performed by licensed personnel. The exception is for a low dose-rate remote
afterloader in which the above duties can be performed by an authorized medical physicist. The
licensee must retain all records of installation, maintenance, adjustment, and repair of the remote
afterloader units, teletherapy units, or gamma stereotactic radiosurgery units as per 10 CFR
35.2605 requirements.
35.610 Safety procedures and instructions for remote afterloader units, teletherapy units,
and gamma stereotactic radiosurgery units (summarized by Collin Nappi)
The licensee should be the one who makes sure the treatment unit is secure and safe when not in
use. This includes ensuring access will not be granted to those not supposed to be in the room.
The determine who should be in the room during treatment and who should be able to hold the
sources. This person also should prevent dual operation of more than one radiation producing
device as much as possible. They should also develop and implement procedures for when
abnormal situations occur when the source is being placed or removed from the subject. This
includes instructions for responding to equipment failures, restricting access to treatment rooms
to minimize excess radiation exposure, and the names and telephone numbers of authorized users
to be contacted if necessary. The licensee should provide operational and safety instructions
initially and at least annually to all individuals who operate the unit at the facility.
35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units (summarized by Collin Nappi)
The licensee oversees controlling access to the treatment room from every entrance. They also
must ensure that each treatment room is equipped with an electrical interlock system which
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prevent the operator from initiating the treatment cycle unless the door is closed and cause the
sources to be shielded when the door is opened. Through the use of radiation monitors, any
individual entering the treatment room must be assured that radiation levels are safe to enter the
room. An dual intercom system must be equipped in the treatment room. Medium dose-rate and
pulsed dose-rate remote afterloader units require an authorized medical physicist or an
authorized user to be physically present at the initiation of all patient treatments involving the
unit. This is the same for high dose as well as for gamma stereotactic radiosurgery units.
Applicable emergency response equipment must be available in case of a source remaining in the
unshielded position or being lodged in a patient.
35.630 Dosimetry equipment (summarized by Collin Nappi)
All dosimetric equipment must be calibrated to be available for use. Low dose-rate can be
determined by the manufacturer. To satisfy the requirements of a calibrated dosimetry system,
the system must have been calibrated using a system or source traceable to the National Institute
of Standards and Technology (NIST) or by a calibration laboratory accredited by the American
Association of Physicists in Medicine (AAPM). These calibrations must be performed within the
previous 2 years and after any servicing that may have affected the calibration. Or the system
must have been calibrated within the previous 4 years and intercompared with another dosimetry
system calibrated in the past 24 months by NIST or AAPM. The results of the intercomparison
cannot be more than 2%. The dosimetry system must be available for spot-check output
measurements, if applicable. Also, a record of each calibration, intercomparison, and comparison
in accordance with 35.2630 must be retained at all times.
35.632 Full calibration measurements on teletherapy units. (summarized by Dakota
Sturgess)
An individual who is authorized to use a teletherapy unit shall perform the full calibration
measurements on each teletherapy unit. Mush be before the first medical use of the unit and
before medical use under the following conditions:
· Whenever spot-check measurements indicate that the output differs by more than 5
percent from the output obtained at the last full calibration
· Following replacement of the source
· Following any repair of the teletherapy units
· Intervals not exceeding 1 year
Full calibration must include determination of the output within +/- 3 percent for the range of
the field sizes. The coincidence of the radiation field and the field indicated by the light beam
localizing device. The uniformity of the radiation field. Timer accuracy and linearity over the
range of use. A record of each calibration in accordance with 35.2632.
35.633 Full calibration measurements on remote afterloader units. (summarized by Dakota
Sturgess)
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An individual authorized to use a remote afterloader unit for medical use should perform the full
calibration measurement. Before the first medical use of the unit and before the use under the
following conditions:
· Replacement of the source
· Following any repair
· Intervals not exceeding 1 quarter for high dose-rate
· Interval not exceeding 1 year for low dose-rate
Full calibration measurements must include the output within+/- 5 percent. Source position
accuracy within +/- 1mm. Source reaction with backup battery upon power failure. Length of the
source transfer tubes. A licensee shall mathematically correct the outputs determined for
physical decay at intervals consistent with 1 percent physical decay. Full calibration
measurements required of this section required by a medical physicist.
35.635 Full calibration measurements on gamma stereotactic radiosurgery units.
(summarized by Dakota Sturgess)
An individual authorized to use gamma stereotactic radiosurgery unit for medical use should
perform full calibration measurements on each unit before the first medical use of the unit.
Medical use can be defined under the following conditions:
· Whenever spot-check measurement indicate that the output differs by more than 5
percent
· Following replacement of the sources or reinstallation
· Any major repair
· Intervals not exceeding 1 year
· Output within +/- 3 percent
A licensee shall use the dosimetry system described in 35.630 to measure the output for one set
of exposure conditions. A licensee shall make full calibration measurements required of this
section in accordance with published protocols accepted by nationally recognized bodies. Full
calibration measurements required by paragraph (a) of this section and physical decay
corrections required of this section must be performed by the authorized medical physicist.
35.642 Periodic spot-checks for teletherapy units (summarized by Melissa Wojno)
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 timer accuracy, on-off
error, accuracy of localization devices, and the 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
electrical interlocks at the room entrance, electrical or mechanical stops installed for limiting the
beam of radiation (on-off mechanism), viewing and intercom systems, and 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.
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35.643 Periodic spot-checks for remote afterloader units (summarized by Melissa Wojno)
A licensee authorized to use a remote afterloader unit for medical purposes must complete spot-
checks of each afterloader facility. On each unit, a spot-check must be completed before the first
use of a high/medium/pulsed dose-rate, before each treatment of low dose-rate, and after each
source installation of the remote afterloader unit. 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 electrical interlocks at the room
entrance, source exposure indicator lights, viewing/intercom system, emergency response
equipment, radiation monitors, timer accuracy, clock, and the decayed source activity. 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.
35.645 Periodic spot-checks for gamma stereotactic radiosurgery units (summarized by
Melissa Wojno)
A licensee authorized to use a gamma stereotactic radiosurgery (gamma SRS) unit for medical
purposes must complete spot-checks of each gamma SRS facility. These spot checks must be
completed monthly, before the first use of the unit, and after each source installation. 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
the treatment table retraction with the unit off using backup power, helmet microswitches,
emergency timing circuits, and localizing devices. The checks also determine the output for set
operating systems, anticipated output, source output, timer accuracy, on-off error, and Trunnion
centricity. This ensures that the electrical interlocks at the room entrance, source exposure
indicator lights, viewing/intercom system, timer termination, monitors displaying room
exposures, and emergency off buttons are operating correctly. 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.
35.647 Additional technical requirements for mobile remote afterloader units (summarized
by Dylan Tripoli)
This section outlines requirements when using afterloader units in a remote setting. Licensed
users providing mobile remote afterloder services must check the instruments over thoroughly
prior to every use and at each address they are used. Additionally, they must always account for
all sources before leaving a site of use. Mobile afterloader units must also follow the periodic
spot checks laid out in section 35.643. At a minimum, these checks must include electrical
interlocks, all source exposure indicator lights, intercom systems, applicators, source transfer
tubes, tube-applicator interfaces, radiation monitors, source positioning accuracy, and the
monitor used to indicate the source has returned to the safe shielded position. Finally, the user
must also complete a simulated cycle of treatment prior to use at each new address. If the unit
fails any of the tests, the licensee must lock the control console and ensure it is not used until
fixed. It is the licensee's responsibility to keep documentation of these checks.
35.652 Radiation surveys (summarized by Dylan Tripoli)
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This section describes it is an addition to the requirements in 20.1501. Licensed individuals must
complete radiation surveys to ensure maximum and average radiation levels from the source in
the shielded position do not exceed levels as stated in the Sealed Source and Device Registry.
This survey must be done in a few situations such as: when a new source is installed and
following repairs to source shielding, driving unit, or other mechanical components that could
potentially compromise the safety of the source. It is the responsibility of the licensee to keep
documentation of these surveys.
35.655 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units
(summarized by Dylan Tripoli)
This section described that a licensee must have teletherapy and gamma stereotactic radiosurgery
units serviced and inspected thoroughly after the installation of new sources. The purpose of this
check is to ensure all safety and exposure components of the machine are functioning as they
should be for patient treatment. Time between these checks should not exceed 5 years for
teletherapy machines and 7 years for gamma stereotactic machines, regardless of if there has
been a new source change or not. Servicing must be completed by a professional licensed by the
commission or an agreement state. It is the responsibility of the licensee to keep documentation
of the inspection and servicing.
35.657 Therapy-related computer systems (summarized by Collin Nappi)
Acceptance test on the treatment planning system must be performed by the licensee in
accordance with published protocols accepted by nationally recognized bodies. The acceptance
testing must include verification:
 Verification of source-specific input parameters
 Accuracy of dose, dwell time, and treatment time calculations at representative points
 Accuracy of isodose plots and graphic displays
 Accuracy of the software used to determine sealed source positions from radiographic
images
 Accuracy of electronic transfer of treatment delivery parameters
35.690 Training for use of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units (summarized by Collin Nappi)
Authorized users of sealed sources must be certified by a medical specialty board whose
certification process has been recognized by the commission or an agreement state who meets
the requirements of this section. They must complete a minimum of 3 years of an accredited
residency training in radiation therapy program. They must also pass an examination which tests
knowledge and competence in radiation safety, radionuclide handling, treatment planning,
quality assurance, and clinical use of stereotactic radiosurgery, remote aferloaders, and external
beam therapy. Thye must have completed a structured educational program in basic radionuclide
techniques along with 500 hours of work experience under supervision of an authorized user who
meets these requirements. They must have 3 years of supervised clinical experience in radiation
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therapy. They also must have obtained written attestation that the individual has satisfactorily
completed the requirements above.