Chapter 2: Scoping
M201.1 Application by Enforcing Authority.
The enforcing authority shall specify the number and type of diagnostic equipment that are required to comply with the MDE Standards.
M201.2 General Exception.
Medical diagnostic equipment shall not be required to comply with one or more applicable requirements in the MDE Standards in the rare circumstances where compliance would alter diagnostically required structural or operational characteristics of the equipment and would prevent the use of the equipment for its intended diagnostic purpose. Diagnostic equipment subject to M201.2 shall comply to the maximum extent practicable.
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