Electromagnetic Compatibility (EMC) is the ability of a device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference), without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices. EMC information in a submission is reviewed based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.
Manufacturers generally refer to International Electrotechnical Commission (IEC) 60601-1-2 or the equivalent US versions for EMC in pre-market submissions in addition to device specific consensus standards or “particular” standards under IEC 60601. In this guidance, FDA has issued a list of information to be submitted with the EMC to facilitate premarket submission and review. The information list is consistent with the specification included in the appropriate standards will help to ensure that clear and consistent information is provided in premarket submission about EMC.
I For more information about the guidance please visit Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.
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