4731 RADIATION SAFETY

4731.4413 AUTHORIZED NUCLEAR PHARMACIST TRAINING. Subpart 1. Training and education requirements. Except as provided in part 4731.4414, a licensee must require an authorized nuclear pharmacist to be a pharmacist who: A. is certified by a specialty board whose certification proces…

4731.4414 TRAINING; EXPERIENCED RADIATION SAFETY OFFICER, TELETHERAPY OR MEDICAL PHYSICIST, AUTHORIZED USER, AND NUCLEAR PHARMACIST. A. An individual identified as a radiation safety officer, a teletherapy or medical physicist, or a nuclear pharmacist on a license issued by the N…

4731.4415 RECENTNESS OF TRAINING. The training and experience specified under parts 4731.4405 to 4731.4414 and 4731.4432 to 4731.4479 must have been obtained within the seven years preceding the date of application or the individual must have had related continuing education and …

4731.4420 MEASURING ACTIVITY OF UNSEALED RADIOACTIVE MATERIAL; INSTRUMENTS REQUIRED. A. For direct measurements performed according to part 4731.4422, a licensee must possess and use instrumentation to measure the activity of unsealed radioactive material before it is administere…

4731.4421 CALIBRATION OF SURVEY INSTRUMENTS. A. A licensee must calibrate the survey instruments used to show compliance with parts 4731.2000 to 4731.2950 and 4731.4400 to 4731.4527 before first use, intervals not to exceed 12 months, and following a repair that affects the calib…

4731.4422 DETERMINATION OF DOSAGES; UNSEALED RADIOACTIVE MATERIAL. A. A licensee must determine and record the activity of each dosage before medical use. B. For a unit dosage, the determination under item A must be made by: (1) direct measurement of radioactivity; or (2) a decay…

4731.4423 AUTHORIZATION FOR CHECK, CALIBRATION, TRANSMISSION, AND REFERENCE USE. Subpart 1. Check, calibration, transmission, and reference use. A person authorized under part 4731.4403, subpart 1, for medical use of radioactive material may receive, possess, and use the followin…

4731.4424 POSSESSION OF SEALED SOURCES AND BRACHYTHERAPY SOURCES; REQUIREMENTS. A. A licensee in possession of any sealed source or brachytherapy source must follow the radiation safety and handling instructions supplied by the manufacturer. B. A licensee in possession of a seale…

4731.4425 LABELING VIALS AND SYRINGES. Each syringe and vial that contains unsealed radioactive material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded. St…

4731.4426 SURVEYS OF AMBIENT RADIATION EXPOSURE RATE. A. In addition to the surveys required under parts 4731.2000 to 4731.2950, a licensee must survey with a radiation detection survey instrument at the end of each day of use all areas where unsealed radioactive materials requir…

4731.4427 RELEASE OF INDIVIDUALS CONTAINING UNSEALED RADIOACTIVE MATERIAL OR IMPLANTS. A. A licensee may authorize release from licensee control of an individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effec…

4731.4428 MOBILE MEDICAL SERVICE. A. A licensee providing mobile medical service must: (1) obtain a letter signed by the management of each client for which services are rendered that permits the use of radioactive material at the client's address and clearly delineates the autho…

4731.4429 DECAY-IN-STORAGE. A licensee may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity, if the licensee adheres to the requirements of part 4731.2405. Statutory Auth…

4731.4430 CONTROL OF AEROSOLS AND GASES. Subpart 1. Collection system. A licensee who administers radioactive aerosols or gases must do so with a system that will keep airborne concentrations within the limits prescribed by parts 4731.2020 and 4731.2090. Subp. 2. System vented or…

4731.4432 UNSEALED RADIOACTIVE MATERIAL; UPTAKE, DILUTION, AND EXCRETION STUDIES; WRITTEN DIRECTIVE NOT REQUIRED. Except for quantities that require a written directive under part 4731.4408 or 4731.4409, a licensee may use any unsealed radioactive material prepared for medical us…

4731.4433 UPTAKE, DILUTION, AND EXCRETION STUDIES; TRAINING. Subpart 1. Training and education requirements. Except as provided under part 4731.4414, a licensee must require the authorized user of unsealed radioactive material for the uses authorized under part 4731.4432 to be a …

4731.4434 UNSEALED RADIOACTIVE MATERIAL; IMAGING AND LOCALIZATION STUDIES; WRITTEN DIRECTIVE NOT REQUIRED. Except for quantities that require a written directive under part 4731.4408, a licensee may use any unsealed radioactive material prepared for medical use for imaging and lo…

4731.4435 PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATION. A. A licensee may not administer to humans a radiopharmaceutical that contains: (1) more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m (0.15 kilobecquerel of molybdenum-99 …

4731.4436 IMAGING AND LOCALIZATION STUDIES; TRAINING. Subpart 1. Training and education requirements. Except as provided under part 4731.4414, a licensee must require an authorized user of unsealed radioactive material for the uses authorized under part 4731.4434 to be a physicia…

4731.4440 UNSEALED RADIOACTIVE MATERIAL; WRITTEN DIRECTIVE REQUIRED. A licensee may use any unsealed radioactive material identified in part 4731.4443, subpart 1, item B, subitem (1), unit (b), subunit vi, prepared for medical use and for which a written directive is required tha…

4731.4441 SAFETY INSTRUCTIONS. A. In addition to the requirements of part 4731.1020, a licensee must provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under part 4731.4427. To …

4731.4442 SAFETY PRECAUTIONS. A. For each patient or human research subject who cannot be released under part 4731.4427, a licensee must: (1) quarter the patient or the human research subject in: (a) a private room with a private sanitary facility; or (b) a room, with a private s…

4731.4443 UNSEALED RADIOACTIVE MATERIAL; WRITTEN DIRECTIVE REQUIRED; TRAINING. Subpart 1. Training and education requirements. Except as provided under part 4731.4414, a licensee must require an authorized user of unsealed radioactive material for the uses authorized under part 4…

4731.4444 ORAL ADMINISTRATION OF SODIUM IODIDE I-131; QUANTITIES LESS THAN OR EQUAL TO 33 MILLICURIES (1.22 GBq); WRITTEN DIRECTIVE REQUIRED; TRAINING. Except as provided under part 4731.4414, a licensee must require an authorized user for the oral administration of sodium iodide…

4731.4445 ORAL ADMINISTRATION OF SODIUM IODIDE; QUANTITIES GREATER THAN 33 MILLICURIES (1.22 GBq); WRITTEN DIRECTIVE REQUIRED; TRAINING. Except as provided under part 4731.4414, a licensee must require an authorized user for the oral administration of sodium iodide (I-131) requir…

4731.4446 PARENTERAL ADMINISTRATION OF UNSEALED RADIOACTIVE MATERIAL; WRITTEN DIRECTIVE REQUIRED; TRAINING. A. Except as provided in part 4731.4414, the licensee must require an authorized user for the parenteral administration requiring a written directive to be a physician who …

4731.4450 USE OF BRACHYTHERAPY SOURCES. A licensee must use only brachytherapy sources: A. as approved in the sealed source and device registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly…

4731.4451 SURVEYS AFTER SOURCE IMPLANT AND REMOVAL. A. Immediately after implanting sources in a patient or human research subject, a licensee must make a survey to locate and account for all sources that have not been implanted. B. Immediately after removing the last temporary i…

4731.4452 BRACHYTHERAPY SOURCES ACCOUNTABILITY. A. A licensee must maintain accountability at all times for all brachytherapy sources in storage or use. B. As soon as possible after removing sources from a patient or human research subject, a licensee must return brachytherapy so…

4731.4453 BRACHYTHERAPY; SAFETY INSTRUCTIONS. A. In addition to the requirements of part 4731.1020, a licensee must provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy a…

4731.4454 BRACHYTHERAPY; SAFETY PRECAUTIONS. A. For each patient or human research subject who is receiving brachytherapy and cannot be released under part 4731.4427, a licensee must: (1) not quarter the patient or human research subject in the same room as an individual who is n…

4731.4455 BRACHYTHERAPY; CALIBRATION MEASUREMENTS. A. Before the first medical use of a brachytherapy source, a licensee must have: (1) determined the source output or activity using a dosimetry system that meets the requirements of part 4731.4468, subpart 1; (2) determined sourc…

4731.4456 DECAY OF STRONTIUM-90 SOURCES FOR OPHTHALMIC TREATMENTS. A. Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in item B are performed by either: (1) an authorized medical physicist; or (2) an individual who: (a) is…

4731.4457 THERAPY-RELATED COMPUTER SYSTEMS. A licensee must perform acceptance testing on the treatment planning system of therapy-related computer systems according to published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include…

4731.4458 MANUAL BRACHYTHERAPY TRAINING. Subpart 1. Training and education requirements. Except as provided under part 4731.4414, a licensee must require an authorized user of a manual brachytherapy source for the uses authorized under part 4731.4450 to be a physician who: A. is …

4731.4459 OPHTHALMIC USE OF STRONTIUM-90; TRAINING. Except as provided under part 4731.4414, a licensee must require an authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who: A. is an authorized user under part 4731.4458 or equivalent requirements of t…

4731.4460 USE OF SEALED SOURCES AND MEDICAL DEVICES FOR DIAGNOSIS. A. A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the sealed source and device registry for diagnostic medicine. The seale…

4731.4461 USE OF SEALED SOURCES FOR DIAGNOSIS; TRAINING. Except as provided under part 4731.4414, a licensee must require an authorized user of a diagnostic sealed source or a device authorized under part 4731.4460 to be a physician, dentist, or podiatrist who: A. is certified by…

4731.4463 USE OF A SEALED SOURCE; REMOTE AFTERLOADER UNIT, TELETHERAPY UNIT, OR GAMMA STEREOTACTIC RADIOSURGERY UNIT. A. A licensee must only use sealed sources: (1) approved and as provided for in the sealed source and device registry in photon-emitting remote afterloader units,…

4731.4464 TREATMENT WITH REMOTE AFTERLOADER UNIT; SURVEYS. A. Before releasing a patient or human research subject who has been treated with a remote afterloader unit from licensee control, a licensee must survey the patient or human research subject and the remote afterloader un…

4731.4465 INSTALLATION, MAINTENANCE, ADJUSTMENT, AND REPAIR REQUIREMENTS. A. Only a person specifically licensed by the commissioner, the NRC, or an agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radio…

4731.4466 REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS; SAFETY PROCEDURES AND INSTRUCTIONS. A. This part applies to remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. B. A licensee must: (1) secure the…

4731.4467 REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS; SAFETY PRECAUTIONS. A. This part applies to remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. B. A licensee must control access to the treatment…

4731.4468 DOSIMETRY EQUIPMENT. Subpart 1. Required equipment. Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee must have a calibrated dosimetry system available for use. To satisfy this requireme…

4731.4469 TELETHERAPY UNITS; FULL CALIBRATION. Subpart 1. Calibration required. A licensee authorized to use a teletherapy unit for medical use must perform full calibration measurements on each teletherapy unit: A. before the first medical use of the unit; B. before medical use …

4731.4470 REMOTE AFTERLOADER UNITS; FULL CALIBRATION. Subpart 1. Calibration required. A licensee authorized to use a remote afterloader unit for medical use must perform full calibration measurements on each unit: A. before the first medical use of the unit; B. before medical us…

4731.4471 GAMMA STEREOTACTIC RADIOSURGERY UNITS; FULL CALIBRATION. Subpart 1. Calibration required. A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform full calibration measurements on each unit: A. before the first medical use of the …