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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
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, strontium-82, and strontium-85 concentrations. |
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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, strontium-82, and strontium-85 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
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