# 10 C.F.R. § 32.55 (2026): Same: Quality assurance, prohibition of transfer

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_55

## Section

- **Citation:** 10 C.F.R. § 32.55 (2026)
- **Heading:** Same: Quality assurance, prohibition of transfer
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 10 CFR: Energy / Chapter I: NUCLEAR REGULATORY COMMISSION / Part 32: SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL / Subpart B: Generally Licensed Items / § 32.55: § 32.55   Same: Quality assurance, prohibition of transfer.

## Text

(a) Each person licensed under § 32.53 shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147.
(b) Each person licensed under § 32.53 shall:
(1) Maintain quality assurance systems in the manufacture of the luminous safety device 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 (c) of this section and in the license issued under § 32.53, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.
(c) The licensee 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 adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.
(2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective:
(i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device;
(ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and
(iii) Any other criteria specified in the license issued under § 32.53.
ing in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device;
(ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and
(iii) Any other criteria specified in the license issued under § 32.53.
(d) No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter, or under an equivalent general license of an Agreement State:
(1) Any luminous safety device tested and found defective under any condition of a license issued under § 32.53, or paragraph (b) of this section, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or
(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (b)(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 § 32.53; and
(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.53.
[77 FR 43693, July 25, 2012]

## Nearby sections

- [10 C.F.R. § 32.51 (2026) § 32.51   Byproduct material contained in devices for use under § 31.5; requirements for license to manufacture, or initially transfer.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_51.md)
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- [10 C.F.R. § 32.52 (2026) § 32.52   Same: material transfer reports and records.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_52.md)
- [10 C.F.R. § 32.53 (2026) § 32.53   Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_53.md)
- [10 C.F.R. § 32.54 (2026) § 32.54   Same: Labeling of devices.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_54.md)
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- [10 C.F.R. § 32.56 (2026) § 32.56   Same: Material transfer reports.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_56.md)
- [10 C.F.R. § 32.57 (2026) § 32.57   Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_57.md)
- [10 C.F.R. § 32.58 (2026) § 32.58   Same: Labeling of devices.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_58.md)
- [10 C.F.R. § 32.59 (2026) § 32.59   Same: Leak testing of each source.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_59.md)
- [10 C.F.R. § 32.61 (2026) § 32.61   Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_61.md)
- [10 C.F.R. § 32.62 (2026) § 32.62   Same: Quality assurance; prohibition of transfer.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_62.md)
- [10 C.F.R. § 32.71 (2026) § 32.71   Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license.](https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_71.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T10_P32_S32_55. Check the current official text before relying on it. Not legal advice.
