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FIRMS MUST INCLUDE EMC TEST RESULTS AND CRITERIA WHEN DECLARING CONFORMANCE TO IEC 60601-1-2 STANDARD; FDA TO PUBLISH 60601 ADOPTION PROPOSAL IN COMING WEEKS

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers declaring conformity to the International Electrotechnical Commission's 60601-1-2 electromagnetic compatibility standard must include data from the EMC testing performed, FDA says in an Oct. 10 draft Blue Book memo to Office of Device Evaluation review staff. The memo is intended to provide ODE reviewers guidance on the use of the IEC 60601 series of device safety standards during the evaluation of premarket submissions.
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