PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
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Subpart A—General Information
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.
35.12 Application for license, amendment, or renewal.
35.15 Exemptions regarding Type A specific licenses of broad scope.
Subpart B—General Administrative Requirements
35.24 Authority and responsibilities for the radiation protection program.
35.26 Radiation protection program changes.
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.
Subpart C—General Technical Requirements
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.
35.80 Provision of mobile medical service.
Subpart D—Unsealed Byproduct Material—Written Directive Not Required
35.190 Training for uptake, dilution, and excretion studies.
35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
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.
35.390 Training for use of unsealed byproduct material for which a written directive is required.
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.
35.432 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
35.604 Surveys of patients and human research subjects treated with a remote afterloader unit.
35.605 Installation, maintenance, adjustment, and repair.
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.
35.655 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.
35.657 Therapy-related computer systems.
Subpart I [Reserved]
Subpart J [Reserved]
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.
35.2061 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.
35.2080 Records of mobile medical services.
35.2092 Records of decay-in-storage.
35.2204 Records of molybdenum-99, strontium-82, and strontium-85 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.
35.2610 Records of safety procedures.
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
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223, 234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy Reorganization Act sec. 201, 206 (42 U.S.C. 5841, 5842, 5846); sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, sec. 651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 U.S.C. 2014, 2021, 2021b, 2111).
Source: 67 FR 20370, Apr. 24, 2002, unless otherwise noted.
[72 FR 55864 Oct. 1, 2007; 77 FR 39906, Jul. 6, 2012]