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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, 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.

[72 FR 55864 Oct. 1, 2007; 77 FR 39906, Jul. 6, 2012]

Page Last Reviewed/Updated Tuesday, March 11, 2014