2004 CFR Title 10, Volume 1

Title 10--Energy CHAPTER I--NUCLEAR REGULATORY COMMISSION PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
	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.
	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 user, and 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.
	35.67	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.
	35.200	Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
	35.204	Permissible molybdenum-99 concentration.
	35.290	Training for imaging and localization studies.
	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.
	35.392	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).
	35.400	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.
	35.500	Use of sealed sources for diagnosis.
	35.590	Training for use of sealed sources for diagnosis.
	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.
	35.900	Radiation Safety Officer.
	35.910	Training for uptake, dilution, and excretion studies.
	35.920	Training for imaging and localization studies.
	35.930	Training for therapeutic use of unsealed byproduct material.
	35.932	Training for treatment of hyperthyroidism.
	35.934	Training for treatment of thyroid carcinoma.
	35.940	Training for use of brachytherapy sources.
	35.941	Training for ophthalmic use of strontium-90.
	35.950	Training for use of sealed sources for diagnosis.
	35.960	Training for use of therapeutic medical devices.
	35.961	Training for authorized medical physicist.
	35.980	Training for an authorized nuclear pharmacist.
	35.981	Training for experienced nuclear pharmacists.
	35.1000	Other medical uses of byproduct material or radiation from byproduct material.
	35.2024	Records of authority and responsibilities for radiation protection programs.
	35.2026	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 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.
	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.
	35.4001	Violations.
	35.4002	Criminal penalties.