Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer.

CFR · 2024-01-01 · US · Title 10

Each person licensed under § 32.30 shall: (a) Carry out adequate control procedures in the manufacture of the device to ensure that each production lot meets the quality control standards approved by the Commission; (b) Label or mark each device and its point-of-sale package so that: (1) Each item has a durable, legible, readily visible label or marking on the external surface of the device containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name of the radionuclide(s) and quantity(ies) of activity; (iii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and (iv) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information). (2) The external surface of the point-of-sale package has a legible, readily visible label or marking containing: (i) The name of the radionuclide and quantity of activity; (ii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and (iii) The following or a substantially similar statement: “THIS DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 10 CFR 32.3

official document · source cfr-2024 · id 10:§ 32.32