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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 10 - Energy |
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Chapter I - Nuclear Regulatory Commission |
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Part 35 - Medical Use of Byproduct Material |
| Subpart A - General Information |
| § 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. |
| Subpart B - General Administrative Requirements |
| § 35.20 - ALARA program. |
| § 35.21 - Radiation Safety Officer. |
| § 35.22 - Radiation Safety Committee. |
| § 35.23 - Statements of authority and responsibilities. |
| § 35.24 - Authority and responsibilities for the radiation protection program. |
| § 35.25 - Supervision. |
| § 35.26 - Radiation protection program changes. |
| § 35.27 - Supervision. |
| § 35.29 - Administrative requirements that apply to the provision of mobile nuclear medicine service. |
| § 35.31 - Radiation safety program changes. |
| § 35.32 - Quality management program. |
| § 35.33 - Notifications, reports, and records of misadministrations. |
| § 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 and Associate 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 medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. |
| § 35.59 - Recentness of training. |
| Subpart C - General Technical Requirements |
| § 35.52 - Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides. |
| § 35.53 - Measurement of dosages of unsealed byproduct material for medical use. |
| § 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. |
| § 35.90 - Storage of volatiles and gases. |
| § 35.92 - Decay-in-storage. |
| Subpart D - Unsealed Byproduct Material - Written Directive Not Required |
| § 35.100 - Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required. |
| § 35.120 - Possession of survey instrument. |
| § 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. |
| § 35.290 - Training for imaging and localization studies. |
| Subpart E - Unsealed Byproduct Material - Written Directive Required |
| § 35.205 - Control of aerosols and gases. |
| § 35.220 - Possession of survey instruments. |
| § 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). |
| § 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written directive. |
| Subpart F - Manual Brachytherapy |
| § 35.320 - Possession of survey instruments. |
| § 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 - 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. |
| Subpart G - Sealed Sources for Diagnosis |
| § 35.420 - Possession of survey instrument. |
| § 35.500 - Use of sealed sources and medical devices for diagnosis. |
| § 35.590 - Training for use of sealed sources and medical devices for diagnosis. |
| Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units |
| § 35.520 - Availability of survey instrument. |
| § 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 - 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. |
| Subparts I-J - [Reserved] |
| § 35.606 - License amendments. |
| § 35.620 - Possession of survey instrument. |
| § 35.634 - Periodic spot-checks. |
| § 35.636 - Safety checks for teletherapy facilities. |
| § 35.641 - Radiation surveys for teletherapy facilities. |
| Subparts I-J - [Reserved] |
| Subpart J - Training and Experience Requirements |
| § 35.900 - Radiation Safety Officer. |
| § 35.901 - Training for experienced 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. |
| § 35.970 - Training for experienced authorized users. |
| § 35.971 - Physician training in a three month program. |
| § 35.972 - Recentness of training. |
| § 35.980 - Training for an authorized nuclear pharmacist. |
| § 35.981 - Training for experienced nuclear pharmacists. |
| Subpart K - Other Medical Uses of Byproduct Material or Radiation From Byproduct Material |
| § 35.990 - Violations. |
| § 35.991 - Criminal penalties. |
| § 35.999 - Resolution of conflicting requirements during transition period. |
| § 35.1000 - Other medical uses of byproduct material or radiation from byproduct material. |
| Subpart L - Records |
| § 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. |
| § 35.2404 - 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 full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units. |
| Subpart M - Reports |
| § 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 - xxx |
| Subpart N - Enforcement |
| § 35.4001 - Violations. |
| § 35.4002 - Criminal penalties. |