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Regulations (10 CFR) > PART 35--MEDICAL USE
OF BYPRODUCT MATERIAL
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
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Subpart A--General Information
35.1
Purpose and scope.
35.2
Definitions.
35.5
Maintenance of records.
35.6
Provisions for the protection of human research subjects.
35.7
FDA, other Federal, and State requirements.
35.8
Information collection requirements: OMB approval.
35.10
Implementation.
35.11
License required.
35.12
Application for license, amendment, or renewal.
35.13
License amendments.
35.14
Notifications.
35.15
Exemptions regarding Type A specific licenses of broad scope.
35.18
License issuance.
35.19
Specific exemptions.
Subpart B--General Administrative Requirements
35.24
Authority and responsibilities for the radiation protection
program.
35.26
Radiation protection program changes.
35.27
Supervision.
35.40
Written directives.
35.41
Procedures for administrations requiring a written directive.
35.49
Suppliers for sealed sources or devices for medical use.
35.50
Training for Radiation Safety Officer.
35.51
Training for an authorized medical physicist.
35.55
Training for an authorized nuclear pharmacist.
35.57
Training for experienced Radiation Safety Officer, teletherapy or medical
physicist, authorized medical physicist, authorized user, nuclear
pharmacist, and authorized nuclear pharmacist.
35.59
Recentness of training.
Subpart C--General Technical Requirements
35.60
Possession, use, and calibration of instruments used to measure the
activity of unsealed byproduct material.
35.61
Calibration of survey instruments.
35.63
Determination of dosages of unsealed byproduct material for medical
use.
35.65
Authorization for calibration, transmission, and reference
sources.
35.67
Requirements for possession of sealed sources and brachytherapy
sources.
35.69
Labeling of vials and syringes.
35.70
Surveys of ambient radiation exposure rate.
35.75
Release of individuals containing unsealed byproduct material or implants
containing byproduct material.
35.80
Provision of mobile medical service.
35.92
Decay-in-storage.
Subpart D--Unsealed Byproduct Material--Written Directive Not
Required
35.100
Use of unsealed byproduct material for uptake, dilution, and excretion
studies for which a written directive is not required.
35.190
Training for uptake, dilution, and excretion studies.
35.200
Use of unsealed byproduct material for imaging and localization studies
for which a written directive is not required.
35.204
Permissible molybdenum-99 concentration.
35.290
Training for imaging and localization studies.
Subpart E--Unsealed Byproduct Material--Written Directive
Required
35.300
Use of unsealed by product material for which a written directive is
required.
35.310
Safety instruction.
35.315
Safety precautions.
35.390
Training for use of unsealed byproduct material for which a written
directive is required.
35.392
Training for the oral administration of sodium iodide I-131 requiring a
written directive in quantities less than or equal to 1.22 gigabecquerels
(33 millicuries).
35.394
Training for the oral administration of sodium iodide I–131 requiring a
written directive in quantities greater than 1.22 gigabecquerels (33
millicuries).
35.396
Training for the parenteral administration of unsealed byproduct material
requiring a written directive.
Subpart F--Manual Brachytherapy
35.400
Use of sources for manual brachytherapy.
35.404
Surveys after source implant and removal.
35.406
Brachytherapy sources accountability.
35.410
Safety instruction.
35.415
Safety precautions.
35.432
Calibration measurements of brachytherapy sources.
35.433
Decay of strontium-90 sources for ophthalmic treatments.
35.457
Therapy-related computer systems.
35.490
Training for use of manual brachytherapy sources.
35.491
Training for ophthalmic use of strontium-90.
Subpart G--Sealed Sources for Diagnosis
35.500
Use of sealed sources for diagnosis.
35.590
Training for use of sealed sources for diagnosis.
Subpart H--Photon Emitting Remote Afterloader Units, Teletherapy
Units, and Gamma Stereotactic Radiosurgery Units
35.600
Use of a sealed source in a remote afterloader unit, teletherapy unit, or
gamma stereotactic radiosurgery unit.
35.604
Surveys of patients and human research subjects treated with a remote
afterloader unit.
35.605
Installation, maintenance, adjustment, and repair.
35.610
Safety procedures and instructions for remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units.
35.615
Safety precautions for remote afterloader units, teletherapy units, and
gamma stereotactic radiosurgery units.
35.630
Dosimetry equipment.
35.632
Full calibration measurements on teletherapy units.
35.633
Full calibration measurements on remote afterloader units.
35.635
Full calibration measurements on gamma stereotactic radiosurgery
units.
35.642
Periodic spot-checks for teletherapy units.
35.643
Periodic spot-checks for remote afterloader units.
35.645
Periodic spot-checks for gamma stereotactic radiosurgery units.
35.647
Additional technical requirements for mobile remote afterloader
units.
35.652
Radiation surveys.
35.655
Five-year inspection for teletherapy and gamma stereotactic radiosurgery
units.
35.657
Therapy-related computer systems.
35.690
Training for use of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units.
Subpart I--[Reserved]
Subpart J--Training and Experience Requirements
35.900
Radiation Safety Officer.
35.910
Training for uptake, dilution, and excretion studies.
35.920
Training for imaging and localization studies.
35.930
Training for therapeutic use of unsealed byproduct material.
35.932
Training for treatment of hyperthyroidism.
35.934
Training for treatment of thyroid carcinoma.
35.940
Training for use of brachytherapy sources.
35.941
Training for ophthalmic use of strontium-90.
35.950
Training for use of sealed sources for diagnosis.
35.960
Training for use of therapeutic medical devices.
35.961
Training for authorized medical physicist.
35.980
Training for an authorized nuclear pharmacist.
35.981
Training for experienced nuclear pharmacists.
Subpart K--Other Medical Uses of Byproduct Material or Radiation From
Byproduct Material
35.1000
Other medical uses of byproduct material or radiation from byproduct
material.
Subpart L--Records
35.2024
Records of authority and responsibilities for radiation protection
programs.
35.2026
Records of radiation protection program changes.
35.2040
Records of written directives.
35.2041
Records for procedures for administrations requiring a written
directive.
35.2060
Records of calibrations of instruments used to measure the activity of
unsealed byproduct materials.
35.2061
Records of radiation survey instrument calibrations.
35.2063
Records of dosages of unsealed byproduct material for medical use.
35.2067
Records of leaks tests and inventory of sealed sources and brachytherapy
sources.
35.2070
Records of surveys for ambient radiation exposure rate.
35.2075
Records of the release of individuals containing unsealed byproduct
material or implants containing byproduct material.
35.2080
Records of mobile medical services.
35.2092
Records of decay-in-storage.
35.2204
Records of molybdenum-99 concentrations.
35.2310
Records of safety instruction.
35.2404
Records of surveys after source implant and removal.
35.2406
Records of brachytherapy source accountability.
35.2432
Records of calibration measurements of brachytherapy sources.
35.2433
Records of decay of strontium-90 sources for ophthalmic
treatments.
35.2605
Records of installation, maintenance, adjustment, and repair of remote
afterloader units, teletherapy units, and gamma stereotactic radiosurgery
units.
35.2610
Records of safety procedures.
35.2630
Records of dosimetry equipment used with remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units.
35.2632
Records of teletherapy, remote afterloader, and gamma stereotactic
radiosurgery full calibrations.
35.2642
Records of periodic spot-checks for teletherapy units.
35.2643
Records of periodic spot-checks for remote afterloader units.
35.2645
Records of periodic spot-checks for gamma stereotactic radiosurgery
units.
35.2647
Records of additional technical requirements for mobile remote afterloader
units.
35.2652
Records of surveys of therapeutic treatment units.
35.2655
Records of 5-year inspection for teletherapy and gamma stereotactic
radiosurgery units.
Subpart M--Reports
35.3045
Report and notification of a medical event.
35.3047
Report and notification of a dose to an embryo/fetus or a nursing
child.
35.3067
Report of a leaking source.
Subpart N--Enforcement
35.4001
Violations.
35.4002
Criminal penalties.
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948,
953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88
Stat. 1242, as amended (42 U.S.C. 5841); Sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note).
Source: 67 FR 20370, Apr. 24, 2002, unless otherwise
noted. | 
