10 CFR 32.62

Same: Quality assurance; prohibition of transfer

a

(a) Each person licensed under § 32.61 shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

b

(b) Each person licensed under § 32.61 shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

c

(c) Each person licensed under § 32.61 shall:

(1) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (d) of this section and in the license issued under § 32.61, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

d

(d) Each person licensed under § 32.61 shall subject each inspection lot to:

(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria for defective: A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device and any other criteria specified in the license issued under § 32.61.

e

(e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter, or under an equivalent general license of an Agreement State:

(1) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under § 32.61, unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (c)(2) of this section, unless:

(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.61; and

(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (c)(2) and (e)(2)(i) of this section and any other criteria as may be required as a condition of the license issued under § 32.61.

Federal Register

[[[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=1965_register&page=9905&position=1%7C 30 FR 9905, Aug. 10, 1965]], as amended at [[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=1974_register&page=22130&position=1%7C 39 FR 22130, June 20, 1974]]; [[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=1974_register&page=26397&position=1%7C 39 FR 26397, July 19, 1974]]; [[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=1978_register&page=6923&position=1%7C 43 FR 6923, Feb. 17, 1978]]; [[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2012_register&page=43694&position=1%7C 77 FR 43694, Jul. 25, 2012]]]

External Links

[[URL::http://www.nrc.gov/reading-rm/doc-collections/cfr/part032/part032-0062.html%7CNRC website 10 CFR 32.62]]

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 32.62

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d

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10 CFR 32.62

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b

c

d

e

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