Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.

CFR · 2024-01-01 · US · Title 10

An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under § 31.10 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; (b) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of strontium-90 in the device; (2) Details of construction and design of the source of radiation and its shielding; (3) Radiation profile of a prototype device; (4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use; (5) Details of quality control procedures to be followed in manufacture of the device; (6) Description of labeling to be affixed to the device; (7) Instructions for handling and installation of the device; (8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device; (c) Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form; (d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescri

official document · source cfr-2024 · id 10:§ 32.61