Home/CFR/Title 10/Part 35
FEDERAL · 10 CFR

Part 35 — Medical Use of Byproduct Material

111 sections · Title 10: Energy

§ 35.1Purpose and scope.
§ 35.2Definitions.
§ 35.5Maintenance of records.
§ 35.6Provisions for the protection of human research subjects.
§ 35.7FDA, other Federal, and State requirements.
§ 35.8Information collection requirements: OMB approval.
§ 35.10Implementation.
§ 35.11License required.
§ 35.12Application for license, amendment, or renewal.
§ 35.13License amendments.
§ 35.14Notifications.
§ 35.15Exemptions regarding Type A specific licenses of broad scope.
§ 35.18License issuance.
§ 35.19Specific exemptions.
§ 35.24Authority and responsibilities for the radiation protection program.
§ 35.26Radiation protection program changes.
§ 35.27Supervision.
§ 35.40Written directives.
§ 35.41Procedures for administrations requiring a written directive.
§ 35.49Suppliers for sealed sources or devices for medical use.
§ 35.50Training for Radiation Safety Officer and Associate Radiation Safety Officer.
§ 35.51Training for an authorized medical physicist.
§ 35.55Training for an authorized nuclear pharmacist.
§ 35.57Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
§ 35.59Recentness of training.
§ 35.60Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.
§ 35.61Calibration of survey instruments.
§ 35.63Determination of dosages of unsealed byproduct material for medical use.
§ 35.65Authorization for calibration, transmission, and reference sources.
§ 35.67Requirements for possession of sealed sources and brachytherapy sources.
§ 35.69Labeling of vials and syringes.
§ 35.70Surveys of ambient radiation exposure rate.
§ 35.75Release of individuals containing unsealed byproduct material or implants containing byproduct material.
§ 35.80Provision of mobile medical service.
§ 35.92Decay-in-storage.
§ 35.100Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
§ 35.190Training for uptake, dilution, and excretion studies.
§ 35.200Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
§ 35.204Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
§ 35.290Training for imaging and localization studies.
§ 35.300Use of unsealed byproduct material for which a written directive is required.
§ 35.310Safety instruction.
§ 35.315Safety precautions.
§ 35.390Training for use of unsealed byproduct material for which a written directive is required.
§ 35.392Training 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).
§ 35.394Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).
§ 35.396Training for the parenteral administration of unsealed byproduct material requiring a written directive.
§ 35.400Use of sources for manual brachytherapy.
§ 35.404Surveys after source implant and removal.
§ 35.406Brachytherapy sources accountability.
§ 35.410Safety instruction.
§ 35.415Safety precautions.
§ 35.432Calibration measurements of brachytherapy sources.
§ 35.433Strontium-90 sources for ophthalmic treatments.
§ 35.457Therapy-related computer systems.
§ 35.490Training for use of manual brachytherapy sources.
§ 35.491Training for ophthalmic use of strontium-90.
§ 35.500Use of sealed sources and medical devices for diagnosis.
§ 35.590Training for use of sealed sources and medical devices for diagnosis.
§ 35.600Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
§ 35.604Surveys of patients and human research subjects treated with a remote afterloader unit.
§ 35.605Installation, maintenance, adjustment, and repair.
§ 35.610Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§ 35.615Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§ 35.630Dosimetry equipment.
§ 35.632Full calibration measurements on teletherapy units.
§ 35.633Full calibration measurements on remote afterloader units.
§ 35.635Full calibration measurements on gamma stereotactic radiosurgery units.
§ 35.642Periodic spot-checks for teletherapy units.
§ 35.643Periodic spot-checks for remote afterloader units.
§ 35.645Periodic spot-checks for gamma stereotactic radiosurgery units.
§ 35.647Additional technical requirements for mobile remote afterloader units.
§ 35.652Radiation surveys.
§ 35.655Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
§ 35.657Therapy-related computer systems.
§ 35.690Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§ 35.1000Other medical uses of byproduct material or radiation from byproduct material.
§ 35.2024Records of authority and responsibilities for radiation protection programs.
§ 35.2026Records of radiation protection program changes.
§ 35.2040Records of written directives.
§ 35.2041Records for procedures for administrations requiring a written directive
§ 35.2060Records of calibrations of instruments used to measure the activity of unsealed byproduct material.
§ 35.2061Records of radiation survey instrument calibrations.
§ 35.2063Records of dosages of unsealed byproduct material for medical use.
§ 35.2067Records of leaks tests and inventory of sealed sources and brachytherapy sources.
§ 35.2070Records of surveys for ambient radiation exposure rate.
§ 35.2075Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.
§ 35.2080Records of mobile medical services.
§ 35.2092Records of decay-in-storage.
§ 35.2204Records of molybdenum-99, strontium-82, and strontium-85 concentrations.
§ 35.2310Records of safety instruction.
§ 35.2404Records of surveys after source implant and removal.
§ 35.2406Records of brachytherapy source accountability.
§ 35.2432Records of calibration measurements of brachytherapy sources.
§ 35.2433Records of decay of strontium-90 sources for ophthalmic treatments.
§ 35.2605Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§ 35.2610Records of safety procedures.
§ 35.2630Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§ 35.2632Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.
§ 35.2642Records of periodic spot-checks for teletherapy units.
§ 35.2643Records of periodic spot-checks for remote afterloader units.
§ 35.2645Records of periodic spot-checks for gamma stereotactic radiosurgery units.
§ 35.2647Records of additional technical requirements for mobile remote afterloader units.
§ 35.2652Records of surveys of therapeutic treatment units.
§ 35.2655Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
§ 35.3045Report and notification of a medical event.
§ 35.3047Report and notification of a dose to an embryo/fetus or a nursing child.
§ 35.3067Report of a leaking source.
§ 35.3204Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
§ 35.4001Violations.
§ 35.4002Criminal penalties.