In general, equipment and devices used in EMC test, cable layout and accessories in typical configuration shall be consistent with those in normal use. If the applicant determines that the inactive accessories are not related to the EMC test after analysis, it is not necessary to test them together with the inactive accessories. The EMC test report shall specify these inactive accessories and the analysis conclusion, and the information of these inactive accessories need not be reflected in the test sample composition table. If the applicant determines that the basic performance of the active medical device must be matched with the inactive accessory after analysis, the electromagnetic compatibility test shall be conducted with the inactive accessories.
Strategy Consulting
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