10 CFR 32.27

Same: Safety criteria An applicant for a license under § 32.26 shall demonstrate that the product is designed and will be manufactured so that:

a

(a) In normal use and disposal of a single exempt unit, and in normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.28.

b

(b) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.

c

(c) In use and disposal of a single exempt unit and in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in § 32.28, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in § 32.28.^[1]

Federal Register

] Low--not more than one such failure per year for each 10,000 exempt units distributed. Negligible--not more than one such failure per year for each one million exempt units distributed.

References

↑ It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria:

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NRC website 10 CFR 32.27

[#N_1_3227-1] It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria:

[1]

v t e Code of Federal Regulations
Title 10 Part 32 - PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
1, Purpose and scope 2, Definitions 3, Maintenance of records 8, Information collection requirements: OMB approval 11, Exempt Concentrations and Items 12, Same: Records and material transfer reports 13, Same: Prohibition of introduction 14, Certain items containing byproduct material; requirements for license to apply or initially transfer 15, Same: Quality assurance, prohibition of transfer, and labeling 16, Certain items containing byproduct material: Records and reports of transfer 17, 18, Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license 19, Same: Conditions of licenses 20, Same: Records and material transfer reports 21, Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for "in vivo" diagnostic use for humans to persons exempt from licensing; Requirements for a license 22, Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer 23, Same: Safety criteria 24, Same: Table of organ doses 25, Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer 26, Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer 27, Same: Safety criteria 28, Same: Table of organ doses 29, Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer 30, Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer 31, Certain industrial devices containing byproduct material: Safety criteria 32, Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer 40, 51, Generally Licensed Items 52, Same: Material transfer reports and records 53, Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer 54, Same: Labeling of devices 55, Same: Quality assurance; prohibition of transfer 56, Same: Material transfer reports 57, Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer 58, Same: Labeling of devices 59, Same: Leak testing of each source 60, 61, Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer 62, Same: Quality assurance; prohibition of transfer 71, Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license 72, Specifically Licensed Items 74, Manufacture and distribution of sources or devices containing byproduct material for medical use 201, Serialization of nationally tracked sources 210, Sealed Source and Device Registration 211, 301, Violations 303, Criminal penalties Appendices:

10 CFR 32.27

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10 CFR 32.27

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