Radiation-Emitting Products

Must a currently certified facility or a facility undergoing certification for the first time have the "final" written report of the equipment evaluation before clinically using a newly added or modified unit?

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No, however, the currently certified facility or a facility undergoing certification for the first time must have, at a minimum, a written document of the test results, provided by the medical physicist, before any clinical use of the new or modified equipment. This initial documentation can simply be a list of all applicable tests performed on the equipment with an indication that the equipment passed all the tests. Mammography equipment evaluations must be performed by qualified medical physicists and must determine whether the new or modified equipment meets the requirements of applicable standards stated in sections 900.12(b) and (e) of the final regulations.

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Page Last Updated: 08/07/2014
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