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U.S. Code of Federal Regula...
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Title 10—Energy
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CHAPTER I—NUCLEAR REGULATOR...
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PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
§ 35.1 - Purpose and scope.
§ 35.2 - Definitions.
§ 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.
§ 35.8 - Information collection requirements: OMB approval.
§ 35.10 - Implementation.
§ 35.11 - License required.
§ 35.12 - Application for license, amendment, or renewal.
§ 35.12 - Application for license, amendment, or renewal.
§ 35.13 - License amendments.
§ 35.13 - License amendments.
§ 35.14 - Notifications.
§ 35.14 - Notifications.
§ 35.15 - Exemptions regarding Type A specific licenses of broad scope.
§ 35.15 - Exemptions regarding Type A specific licenses of broad scope.
§ 35.18 - License issuance.
§ 35.19 - Specific exemptions.
§ 35.24 - Authority and responsibilities for the radiation protection program.
§ 35.24 - Authority and responsibilities for the radiation protection program.
§ 35.26 - Radiation protection program changes.
§ 35.27 - Supervision.
§ 35.40 - Written directives.
§ 35.40 - Written directives.
§ 35.41 - Procedures for administrations requiring a written directive.
§ 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.
§ 35.50 - Training for Radiation Safety Officer and Associate Radiation Safety Officer.
§ 35.51 - Training for an authorized medical physicist.
§ 35.51 - Training for an authorized medical physicist.
§ 35.55 - Training for an authorized nuclear pharmacist.
§ 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.
§ 35.57 - 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.
§ 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.
§ 35.65 - 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.
§ 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.
§ 35.190 - 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.
§ 35.204 - Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
§ 35.290 - Training for imaging and localization studies.
§ 35.290 - Training for imaging and localization studies.
§ 35.300 - Use of unsealed byproduct material for which a written directive is required.
§ 35.300 - Use of unsealed byproduct 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.
§ 35.390 - 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).
§ 35.392 - 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).
§ 35.394 - 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.
§ 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written directive.
§ 35.400 - Use of sources for 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.
§ 35.433 - Strontium-90 sources for ophthalmic treatments.
§ 35.457 - Therapy-related computer systems.
§ 35.490 - Training for use of manual brachytherapy sources.
§ 35.490 - Training for use of manual brachytherapy sources.
§ 35.491 - Training for ophthalmic use of strontium-90.
§ 35.491 - Training for ophthalmic use of strontium-90.
§ 35.500 - Use of sealed sources for diagnosis.
§ 35.500 - Use of sealed sources and medical devices for diagnosis.
§ 35.590 - Training for use of sealed sources for diagnosis.
§ 35.590 - Training for use of sealed sources and medical devices for diagnosis.
§ 35.600 - Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
§ 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.
§ 35.610 - 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.
§ 35.655 - Full-inspection servicing 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.
§ 35.690 - Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§ 35.1000 - Other medical uses of byproduct material or radiation from byproduct material.
§ 35.2024 - Records of authority and responsibilities for radiation protection programs.
§ 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 material.
§ 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.
§ 35.2310 - 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.
§ 35.2655 - Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
§ 35.3045 - Report and notification of a medical event.
§ 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.
§ 35.3204 - Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
§ 35.4001 - Violations.
§ 35.4002 - Criminal penalties.