10 C.F.R. PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
TITLE 10--Energy
CHAPTER I--NUCLEAR REGULATORY COMMISSION
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
Subpart A--GENERAL INFORMATION
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| Provisions for the protection of human research subjects.
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| FDA, other Federal, and State requirements.
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| Information collection requirements: OMB approval.
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| Application for license, amendment, or renewal.
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| Exemptions regarding Type A specific licenses of broad scope.
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Subpart B--GENERAL ADMINISTRATIVE REQUIREMENTS
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| Authority and responsibilities for the radiation protection program.
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| Radiation protection program changes.
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| Procedures for administrations requiring a written directive.
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| Suppliers for sealed sources or devices for medical use.
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| Training for Radiation Safety Officer.
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| Training for an authorized medical physicist.
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| Training for an authorized nuclear pharmacist.
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| Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
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Subpart C--GENERAL TECHNICAL REQUIREMENTS
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| Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.
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| Calibration of survey instruments.
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| Determination of dosages of unsealed byproduct material for medical use.
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| Authorization for calibration, transmission, and reference sources.
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| Requirements for possession of sealed sources and brachytherapy sources.
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| Labeling of vials and syringes.
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| Surveys of ambient radiation exposure rate.
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| Release of individuals containing unsealed byproduct material or implants containing byproduct material.
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| Provision of mobile medical service.
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Subpart D--UNSEALED BYPRODUCT MATERIAL--WRITTEN DIRECTIVE NOT REQUIRED
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| Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
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| Training for uptake, dilution, and excretion studies.
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| Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
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| Permissible molybdenum-99 concentration.
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| Training for imaging and localization studies.
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Subpart E--UNSEALED BYPRODUCT MATERIAL--WRITTEN DIRECTIVE REQUIRED
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| Use of unsealed byproduct material for which a written directive is required.
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| Training for use of unsealed byproduct material for which a written directive is required.
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| 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).
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| Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).
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| Training for the parenteral administration of unsealed byproduct material requiring a written directive.
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Subpart F--MANUAL BRACHYTHERAPY
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| Use of sources for manual brachytherapy.
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| Surveys after source implant and removal.
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| Brachytherapy sources accountability.
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| Calibration measurements of brachytherapy sources.
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| Decay of strontium-90 sources for ophthalmic treatments.
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| Therapy-related computer systems.
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| Training for use of manual brachytherapy sources.
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| Training for ophthalmic use of strontium-90.
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Subpart G--SEALED SOURCES FOR DIAGNOSIS
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| Use of sealed sources for diagnosis.
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| Training for use of sealed sources for diagnosis.
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Subpart H--PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
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| Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
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| Surveys of patients and human research subjects treated with a remote afterloader unit.
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| Installation, maintenance, adjustment, and repair.
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| Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
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| Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
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| Full calibration measurements on teletherapy units.
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| Full calibration measurements on remote afterloader units.
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| Full calibration measurements on gamma stereotactic radiosurgery units.
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| Periodic spot-checks for teletherapy units.
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| Periodic spot-checks for remote afterloader units.
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| Periodic spot-checks for gamma stereotactic radiosurgery units.
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| Additional technical requirements for mobile remote afterloader units.
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| Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.
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| Therapy-related computer systems.
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| Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
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Subparts I-J--[RESERVED]
Subpart K--OTHER MEDICAL USES OF BYPRODUCT MATERIAL OR RADIATION FROM BYPRODUCT MATERIAL
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| Other medical uses of byproduct material or radiation from byproduct material.
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Subpart L--RECORDS
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| Records of authority and responsibilities for radiation protection programs.
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| Records of radiation protection program changes.
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| Records of written directives.
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| Records for procedures for administrations requiring a written directive
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| Records of calibrations of instruments used to measure the activity of unsealed byproduct material.
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| Records of radiation survey instrument calibrations.
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| Records of dosages of unsealed byproduct material for medical use.
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| Records of leaks tests and inventory of sealed sources and brachytherapy sources.
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| Records of surveys for ambient radiation exposure rate.
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| Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.
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| Records of mobile medical services.
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| Records of decay-in-storage.
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| Records of molybdenum-99 concentrations.
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| Records of safety instruction.
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| Records of surveys after source implant and removal.
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| Records of brachytherapy source accountability.
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| Records of calibration measurements of brachytherapy sources.
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| Records of decay of strontium-90 sources for ophthalmic treatments.
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| Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
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| Records of safety procedures.
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| Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
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| Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.
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| Records of periodic spot-checks for teletherapy units.
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| Records of periodic spot-checks for remote afterloader units.
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| Records of periodic spot-checks for gamma stereotactic radiosurgery units.
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| Records of additional technical requirements for mobile remote afterloader units.
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| Records of surveys of therapeutic treatment units.
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| Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units.
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Subpart M--REPORTS
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| Report and notification of a medical event.
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| Report and notification of a dose to an embryo/fetus or a nursing child.
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| Report of a leaking source.
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Subpart N--ENFORCEMENT
