10:1.0.1.1.25.1 | SUBPART A
| Subpart A - General Information | |
10:1.0.1.1.25.1.94.1 | SECTION 35.1
| 35.1 Purpose and scope. | |
10:1.0.1.1.25.1.94.2 | SECTION 35.2
| 35.2 Definitions. | |
10:1.0.1.1.25.1.94.3 | SECTION 35.5
| 35.5 Maintenance of records. | |
10:1.0.1.1.25.1.94.4 | SECTION 35.6
| 35.6 Provisions for the protection of human research subjects. | |
10:1.0.1.1.25.1.94.5 | SECTION 35.7
| 35.7 FDA, other Federal, and State requirements. | |
10:1.0.1.1.25.1.94.6 | SECTION 35.8
| 35.8 Information collection requirements: OMB approval. | |
10:1.0.1.1.25.1.94.7 | SECTION 35.10
| 35.10 Implementation. | |
10:1.0.1.1.25.1.94.8 | SECTION 35.11
| 35.11 License required. | |
10:1.0.1.1.25.1.94.9 | SECTION 35.12
| 35.12 Application for license, amendment, or renewal. | |
10:1.0.1.1.25.1.94.10 | SECTION 35.13
| 35.13 License amendments. | |
10:1.0.1.1.25.1.94.11 | SECTION 35.14
| 35.14 Notifications. | |
10:1.0.1.1.25.1.94.12 | SECTION 35.15
| 35.15 Exemptions regarding Type A specific licenses of broad scope. | |
10:1.0.1.1.25.1.94.13 | SECTION 35.18
| 35.18 License issuance. | |
10:1.0.1.1.25.1.94.14 | SECTION 35.19
| 35.19 Specific exemptions. | |
10:1.0.1.1.25.2 | SUBPART B
| Subpart B - General Administrative Requirements | |
10:1.0.1.1.25.2.94.1 | SECTION 35.24
| 35.24 Authority and responsibilities for the radiation protection program. | |
10:1.0.1.1.25.2.94.2 | SECTION 35.26
| 35.26 Radiation protection program changes. | |
10:1.0.1.1.25.2.94.3 | SECTION 35.27
| 35.27 Supervision. | |
10:1.0.1.1.25.2.94.4 | SECTION 35.40
| 35.40 Written directives. | |
10:1.0.1.1.25.2.94.5 | SECTION 35.41
| 35.41 Procedures for administrations requiring a written directive. | |
10:1.0.1.1.25.2.94.6 | SECTION 35.49
| 35.49 Suppliers for sealed sources or devices for medical use. | |
10:1.0.1.1.25.2.94.7 | SECTION 35.50
| 35.50 Training for Radiation Safety Officer and Associate Radiation Safety Officer. | |
10:1.0.1.1.25.2.94.8 | SECTION 35.51
| 35.51 Training for an authorized medical physicist. | |
10:1.0.1.1.25.2.94.9 | SECTION 35.55
| 35.55 Training for an authorized nuclear pharmacist. | |
10:1.0.1.1.25.2.94.10 | SECTION 35.57
| 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. | |
10:1.0.1.1.25.2.94.11 | SECTION 35.59
| 35.59 Recentness of training. | |
10:1.0.1.1.25.3 | SUBPART C
| Subpart C - General Technical Requirements | |
10:1.0.1.1.25.3.94.1 | SECTION 35.60
| 35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material. | |
10:1.0.1.1.25.3.94.2 | SECTION 35.61
| 35.61 Calibration of survey instruments. | |
10:1.0.1.1.25.3.94.3 | SECTION 35.63
| 35.63 Determination of dosages of unsealed byproduct material for medical use. | |
10:1.0.1.1.25.3.94.4 | SECTION 35.65
| 35.65 Authorization for calibration, transmission, and reference sources. | |
10:1.0.1.1.25.3.94.5 | SECTION 35.67
| 35.67 Requirements for possession of sealed sources and brachytherapy sources. | |
10:1.0.1.1.25.3.94.6 | SECTION 35.69
| 35.69 Labeling of vials and syringes. | |
10:1.0.1.1.25.3.94.7 | SECTION 35.70
| 35.70 Surveys of ambient radiation exposure rate. | |
10:1.0.1.1.25.3.94.8 | SECTION 35.75
| 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material. | |
10:1.0.1.1.25.3.94.9 | SECTION 35.80
| 35.80 Provision of mobile medical service. | |
10:1.0.1.1.25.3.94.10 | SECTION 35.92
| 35.92 Decay-in-storage. | |
10:1.0.1.1.25.4 | SUBPART D
| Subpart D - Unsealed Byproduct Material - Written Directive Not Required | |
10:1.0.1.1.25.4.94.1 | SECTION 35.100
| 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required. | |
10:1.0.1.1.25.4.94.2 | SECTION 35.190
| 35.190 Training for uptake, dilution, and excretion studies. | |
10:1.0.1.1.25.4.94.3 | SECTION 35.200
| 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. | |
10:1.0.1.1.25.4.94.4 | SECTION 35.204
| 35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations. | |
10:1.0.1.1.25.4.94.5 | SECTION 35.290
| 35.290 Training for imaging and localization studies. | |
10:1.0.1.1.25.5 | SUBPART E
| Subpart E - Unsealed Byproduct Material - Written Directive Required | |
10:1.0.1.1.25.5.94.1 | SECTION 35.300
| 35.300 Use of unsealed byproduct material for which a written directive is required. | |
10:1.0.1.1.25.5.94.2 | SECTION 35.310
| 35.310 Safety instruction. | |
10:1.0.1.1.25.5.94.3 | SECTION 35.315
| 35.315 Safety precautions. | |
10:1.0.1.1.25.5.94.4 | SECTION 35.390
| 35.390 Training for use of unsealed byproduct material for which a written directive is required. | |
10:1.0.1.1.25.5.94.5 | SECTION 35.392
| 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). | |
10:1.0.1.1.25.5.94.6 | SECTION 35.394
| 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). | |
10:1.0.1.1.25.5.94.7 | SECTION 35.396
| 35.396 Training for the parenteral administration of unsealed byproduct material requiring a written directive. | |
10:1.0.1.1.25.6 | SUBPART F
| Subpart F - Manual Brachytherapy | |
10:1.0.1.1.25.6.94.1 | SECTION 35.400
| 35.400 Use of sources for manual brachytherapy. | |
10:1.0.1.1.25.6.94.2 | SECTION 35.404
| 35.404 Surveys after source implant and removal. | |
10:1.0.1.1.25.6.94.3 | SECTION 35.406
| 35.406 Brachytherapy sources accountability. | |
10:1.0.1.1.25.6.94.4 | SECTION 35.410
| 35.410 Safety instruction. | |
10:1.0.1.1.25.6.94.5 | SECTION 35.415
| 35.415 Safety precautions. | |
10:1.0.1.1.25.6.94.6 | SECTION 35.432
| 35.432 Calibration measurements of brachytherapy sources. | |
10:1.0.1.1.25.6.94.7 | SECTION 35.433
| 35.433 Strontium-90 sources for ophthalmic treatments. | |
10:1.0.1.1.25.6.94.8 | SECTION 35.457
| 35.457 Therapy-related computer systems. | |
10:1.0.1.1.25.6.94.9 | SECTION 35.490
| 35.490 Training for use of manual brachytherapy sources. | |
10:1.0.1.1.25.6.94.10 | SECTION 35.491
| 35.491 Training for ophthalmic use of strontium-90. | |
10:1.0.1.1.25.7 | SUBPART G
| Subpart G - Sealed Sources for Diagnosis | |
10:1.0.1.1.25.7.94.1 | SECTION 35.500
| 35.500 Use of sealed sources and medical devices for diagnosis. | |
10:1.0.1.1.25.7.94.2 | SECTION 35.590
| 35.590 Training for use of sealed sources and medical devices for diagnosis. | |
10:1.0.1.1.25.8 | SUBPART H
| Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units | |
10:1.0.1.1.25.8.94.1 | SECTION 35.600
| 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit. | |
10:1.0.1.1.25.8.94.2 | SECTION 35.604
| 35.604 Surveys of patients and human research subjects treated with a remote afterloader unit. | |
10:1.0.1.1.25.8.94.3 | SECTION 35.605
| 35.605 Installation, maintenance, adjustment, and repair. | |
10:1.0.1.1.25.8.94.4 | SECTION 35.610
| 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.8.94.5 | SECTION 35.615
| 35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.8.94.6 | SECTION 35.630
| 35.630 Dosimetry equipment. | |
10:1.0.1.1.25.8.94.7 | SECTION 35.632
| 35.632 Full calibration measurements on teletherapy units. | |
10:1.0.1.1.25.8.94.8 | SECTION 35.633
| 35.633 Full calibration measurements on remote afterloader units. | |
10:1.0.1.1.25.8.94.9 | SECTION 35.635
| 35.635 Full calibration measurements on gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.8.94.10 | SECTION 35.642
| 35.642 Periodic spot-checks for teletherapy units. | |
10:1.0.1.1.25.8.94.11 | SECTION 35.643
| 35.643 Periodic spot-checks for remote afterloader units. | |
10:1.0.1.1.25.8.94.12 | SECTION 35.645
| 35.645 Periodic spot-checks for gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.8.94.13 | SECTION 35.647
| 35.647 Additional technical requirements for mobile remote afterloader units. | |
10:1.0.1.1.25.8.94.14 | SECTION 35.652
| 35.652 Radiation surveys. | |
10:1.0.1.1.25.8.94.15 | SECTION 35.655
| 35.655 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.8.94.16 | SECTION 35.657
| 35.657 Therapy-related computer systems. | |
10:1.0.1.1.25.8.94.17 | SECTION 35.690
| 35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.9 | SUBPART I
| Subparts I-J [Reserved] | |
10:1.0.1.1.25.10 | SUBPART K
| Subpart K - Other Medical Uses of Byproduct Material or Radiation From Byproduct Material | |
10:1.0.1.1.25.10.94.1 | SECTION 35.1000
| 35.1000 Other medical uses of byproduct material or radiation from byproduct material. | |
10:1.0.1.1.25.11 | SUBPART L
| Subpart L - Records | |
10:1.0.1.1.25.11.94.1 | SECTION 35.2024
| 35.2024 Records of authority and responsibilities for radiation protection programs. | |
10:1.0.1.1.25.11.94.2 | SECTION 35.2026
| 35.2026 Records of radiation protection program changes. | |
10:1.0.1.1.25.11.94.3 | SECTION 35.2040
| 35.2040 Records of written directives. | |
10:1.0.1.1.25.11.94.4 | SECTION 35.2041
| 35.2041 Records for procedures for administrations requiring a written directive | |
10:1.0.1.1.25.11.94.5 | SECTION 35.2060
| 35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct material. | |
10:1.0.1.1.25.11.94.6 | SECTION 35.2061
| 35.2061 Records of radiation survey instrument calibrations. | |
10:1.0.1.1.25.11.94.7 | SECTION 35.2063
| 35.2063 Records of dosages of unsealed byproduct material for medical use. | |
10:1.0.1.1.25.11.94.8 | SECTION 35.2067
| 35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources. | |
10:1.0.1.1.25.11.94.9 | SECTION 35.2070
| 35.2070 Records of surveys for ambient radiation exposure rate. | |
10:1.0.1.1.25.11.94.10 | SECTION 35.2075
| 35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material. | |
10:1.0.1.1.25.11.94.11 | SECTION 35.2080
| 35.2080 Records of mobile medical services. | |
10:1.0.1.1.25.11.94.12 | SECTION 35.2092
| 35.2092 Records of decay-in-storage. | |
10:1.0.1.1.25.11.94.13 | SECTION 35.2204
| 35.2204 Records of molybdenum-99, strontium-82, and strontium-85 concentrations. | |
10:1.0.1.1.25.11.94.14 | SECTION 35.2310
| 35.2310 Records of safety instruction. | |
10:1.0.1.1.25.11.94.15 | SECTION 35.2404
| 35.2404 Records of surveys after source implant and removal. | |
10:1.0.1.1.25.11.94.16 | SECTION 35.2406
| 35.2406 Records of brachytherapy source accountability. | |
10:1.0.1.1.25.11.94.17 | SECTION 35.2432
| 35.2432 Records of calibration measurements of brachytherapy sources. | |
10:1.0.1.1.25.11.94.18 | SECTION 35.2433
| 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments. | |
10:1.0.1.1.25.11.94.19 | SECTION 35.2605
| 35.2605 Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.11.94.20 | SECTION 35.2610
| 35.2610 Records of safety procedures. | |
10:1.0.1.1.25.11.94.21 | SECTION 35.2630
| 35.2630 Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.11.94.22 | SECTION 35.2632
| 35.2632 Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations. | |
10:1.0.1.1.25.11.94.23 | SECTION 35.2642
| 35.2642 Records of periodic spot-checks for teletherapy units. | |
10:1.0.1.1.25.11.94.24 | SECTION 35.2643
| 35.2643 Records of periodic spot-checks for remote afterloader units. | |
10:1.0.1.1.25.11.94.25 | SECTION 35.2645
| 35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.11.94.26 | SECTION 35.2647
| 35.2647 Records of additional technical requirements for mobile remote afterloader units. | |
10:1.0.1.1.25.11.94.27 | SECTION 35.2652
| 35.2652 Records of surveys of therapeutic treatment units. | |
10:1.0.1.1.25.11.94.28 | SECTION 35.2655
| 35.2655 Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units. | |
10:1.0.1.1.25.12 | SUBPART M
| Subpart M - Reports | |
10:1.0.1.1.25.12.94.1 | SECTION 35.3045
| 35.3045 Report and notification of a medical event. | |
10:1.0.1.1.25.12.94.2 | SECTION 35.3047
| 35.3047 Report and notification of a dose to an embryo/fetus or a nursing child. | |
10:1.0.1.1.25.12.94.3 | SECTION 35.3067
| 35.3067 Report of a leaking source. | |
10:1.0.1.1.25.12.94.4 | SECTION 35.3204
| 35.3204 Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations. | |
10:1.0.1.1.25.13 | SUBPART N
| Subpart N - Enforcement | |
10:1.0.1.1.25.13.94.1 | SECTION 35.4001
| 35.4001 Violations. | |
10:1.0.1.1.25.13.94.2 | SECTION 35.4002
| 35.4002 Criminal penalties. | |