MEDICAL USE OF BYPRODUCT MATERIAL
===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, 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.
- 35.310 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 [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.
- 35.2060 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, 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.
- 35.2605 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: 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.
- 77 FR 39906, Jul. 6, 2012]
External Links
NRC website 10 CFR 35
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