Same: Quality assurance, prohibition of transfer, and labeling.
Each person licensed under § 32.14 shall:
Maintain quality assurance practices in the manufacture of the part or product, or the installation of the part into the product;
Subject inspection lots to such testing as may be required as a condition of the license issued under § 32.14 taking a random sample of the size required by the tables in § 32.110, and for Lot Tolerance Percent Defective of 5.0 percent, accept or reject inspection lots in accordance with the directions of § 32.110; and
Visually inspect each unit, except electron tubes containing byproduct material, in inspection lots. Any unit which has an observable physical defect that could affect containment of the byproduct material shall be considered as a defective unit.
An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (a)(2) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that the operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk of 0.10.
No person licensed under § 32.14 shall transfer to other persons for use under § 30.15 of this chapter or equivalent regulations of an Agreement State:
Any part or product which has been tested and found defective under the criteria and procedures specified in the license issued under § 32.14, unless the defective units have been repaired or reworked and have then met such criteria as may be required as a condition of the license issued under § 32.14; or
Any inspection lot which has been rejected as a result of the procedures in § 32.110 or alternative procedures in paragraph (b) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met such criteria as may be required as a condition of the license issued under § 32.14.
Label or mark each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container so that the manufacturer or initial transferor of the product and the byproduct material in the product can be identified.
For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that:
Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing:
The following statement: “CONTAINS RADIOACTIVE MATERIAL”;
The name of the radionuclide (“americium-241” or “Am-241”) and the quantity of activity; and
An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) of this chapter or equivalent regulations of an Agreement State.
The labeling or marking specified in paragraph (d)(2)(i) of this section is located where it will be readily visible when the detector is removed from its mounting.
The external surface of the point-of-sale package has a legible, readily visible label or marking containing:
The name of the radionuclide and quantity of activity;
An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) or equivalent regulations of an Agreement State; and
The following or a substantially similar statement: “THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.”
Each detector and point-of-sale package is provided with such other information as may be required by the Commission.
[31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 FR 22129, June 20, 1974; 43 FR 6922, Feb. 17, 1978; 72 FR 58487, Oct. 16, 2007; 73 FR 42673, July 23, 2008]