We recently received compliance certification for a medical device from an accredited test lab for EN55011. The requirements are to test the device for radiated electromagnetic emissions at high frequencies. We have had requests as to why the Mil-Std-462, RE101 was not tested. The Mil-Std applies requirements at low frequency from 30Hz up to 30Khz. Does anyone have suggested rationale to why we should be able to justify that testing to EN55011 is sufficient and that testing to the Mil-Std is not a requirement anymore? From my understanding, it may only apply to pulmonary type medical devices. Any input is appreciated.
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