Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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Appendix D: Selected Sections of the Unites States Code of Federal Regulations
Appendix D: Selected Sections of the Unites States Code of Federal Regulations
Pages 201-243
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From page 201... ...
D Selected Sections of the United States Code of Federal Regulationsi ~ 10 CFR Part 20 (Standards for Protection Against Radiation) and 10 CFR Part 35 (Medical Use of Byproduct Material)
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From page 202... ...
20.1203 Determination of external dose from airborne radioactive material. 20.1204 Determination of internal exposure.
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203 §20.tO01 20.Z203 Reports of exposures, radiation levels, and concentrations of radioactive material exceedlag the llmlts. 20.2204 Reports of planned special exam surest 20.2205 "Reserved]
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ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent of 50 rem (0.5 Sv)
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. Dose or radiation dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective do" equivalent, as defined in other paragraphs of this section.
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License means a license issued under the regulations in parts 30 through 36, 39, 40, 50, 60, 61, 70, or 72 of this chapter. Licensed material meam source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general or specific license issued by the Commission.
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From page 207... ...
.2 of §20.1004) that is used to derive dose equivalent from absorbed dose.
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Uranium fuel cycle means the operations of milling of uranium ore, chemical conversion of uranium, isotopic enrichment of uranium, fabrication of uranium fuel, generation of electricity by a light-water-cooled nuclear power plant using uranium fuel, and reprocessing of spent uranium fuel to the extent that these activities directly sum port the production of electrical power for public use. Uranium fuel cycle does not include ruining operations, operations at waste disposal sites, transportation of radioactive material in support of these operations, and the reuse of recovered non-uranium special nuclear and byproduct materials from the cycle.
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The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv=100 rems)
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UALITY FACTORS, (:) , AND FLUENCE PER UNIT DOSE EQUIVALENT FOR MONOENERGETIC NEUTFlONS Fluence per unit case ~UNa.
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The dee~dose equiv 10033 0-94 11 211 § 20.1 202 Blent. eye dose equivalent and shallowdose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring de~rice was not in the region of highest potential exposure.
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as.= Sum. 35.~ Visiting authorized user.
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35.520 Availability of survey instrument. Subpart I-Teletherapy 35.600 Use of a sealed source in a teletherapy unit.
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or podiatrist who is identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material. Brachytherapy source means an individual sealed source or a manufacturerassembled source train that is not designed to be disassembled by the user.
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Mobile nuclear medicine service means the transportation and medical use of byproduct material. Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
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A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10 percent of the prescribed dose. Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.
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From page 217... ...
Before it receives or uses byproduct material for a clinical procedure permitted under this Part but not permitted by the license issued pursuant to this part; (b) Before it permits anyone, except a visiting authorized user described in §35.27, to work as an authorized user under the license (c)
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From page 218... ...
management and all authorzed users must participate in the program as requested by the Radiation Safety Officer. (ci The prog~a..n must include notice to workers of the program's existence and workers' responsibility to help keep dose equip alents ALARA, a review of summaries of the types and amounts of byproduct material used, occupational doses, changes in radiation safety procedures and safety measures, and continuing education and training for all personnel who work with or in the vicinity of byproduct material.
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with the assistance of the Radiation Safety Officer. a summary of the occupational radiation dose records of all personnel working with byproduct material: (5)
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(d) A mobile nuclear medicine service may not order byproduct material to be delivered directly from the manufacturer or distributor to the client's address of use.
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The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management or, in a medical institution, the Radiation Safety Committee's chairman and the management representative. 3632 Quality management program.
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A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (a)
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Byproduct material manufactured, labeled, packaged. and distributed in accordance with a license issued pursuant to the regulations in part 30 and §§32.72, 32.73, or 32.74 of this chapter or the equivalent regulations of an Agreement State; (b)
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Any person authorized by §35.11 of this part for medical use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use: (a) Sealed sources manufactured and distributed by a person licensed pursuant to §32.74 of this chapter or equivalent Agreement State regulations and that do not exceed 15 millicuries each; (b)
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A licensee in possession of a serial number if assigned, of each sealed source or brachytherapy source source tested, the identity of each shall measure the ambient dose rates source radionuclide and its estimated quarterly in all areas where such activity, the measured activity of each sources are stored. This does not apply test sample expressed in microcuries, a to teletherapy sources in teletherapy description of the method used to units or sealed sources in diagnostic measure each test sample, the date of devices.
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(a) A licensee shall keep syringes that contain byproduct material to be administered in a radiation shield.
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of this section for three years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
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From page 228... ...
A licensee authorized to use byproduct material for uptake, dilution, and excretion studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour. Subpart E Imaging and Localization § 35.200 Use of radiopharmaceuticals generators, and reagent kits for imaging and localization studies.
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From page 229... ...
22, 1993] 35.220 Possession of survey instrumenta A licensee authorized to use byproduct material for imaging and localization studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range of 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.
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22, 19931 35e320 Po~emion of survey i~trumente. A licensee authorized to use b~roduct material for radiopharmaceutical therapy shall have in its possession a portable radiation detection survey instrurnent capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.
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From page 231... ...
Authorize visits by individuals under age 18 only on a patient-by-patient basis with the approval of the authorized user after consultation with the Radiation Safety Officer; and (a) Promptly after implanting the material, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement surrey instrument to demonstrate compliance with the requirements of Part 20 of this chapter, and retain for three years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey.
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A licensee authorized to use byproduct material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour. The instrument must have been calibrated in accordance with §35.51 of this part.
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From page 233... ...
35.620 Possession of survey instrument. A licensee authorized to use b~rproduct material in a teletherapy unit shall have in its possession either a portable radiation detection survey instrument capable of detecting dose rate over the range 0.1 millirem per hour to 100 millirem per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1,000 millirem per hour.
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(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit: (1)
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(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-check of each teletherapy facility once in each calendar month that assure proper operation of: 541
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The record must include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, an assessment of timer linearity and constancy, the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the calculated on-off error, the determined accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spotcheck.
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The record must include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the off position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer.
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From page 238... ...
Radiopharmaceutical chemistry; and (2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or (c)
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Supervised clinical experience under the supervision of an authorized user at a medical institution that includes: (i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and (ii)
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Except as provided in §35.970, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic r3.dioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows: (a) 80 hours of classroom and laboratory training that includes: (1)
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35~941 Valuing for ophthalmic use of strontium-8O. Except as provided in §35.970, the licensee shall require the authorized user of only ~trontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows: (a)
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From page 242... ...
35.970 Training for experienced author~zed users. Physicians, dentists, or podiatrists identified as authorized users for the medical, dental, or podiatric use of byproduct material on a Commission or Agreement State license issued before April 1, 1987 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of subpart J
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From page 243... ...
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 1610 of the Act.
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