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U.S. Department of Health and Human Services

About FDA

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Research Project: Electromagnetic Compatibility (EMC)

Immunity testing measures the ability of a medical device to withstand an electromagnetic source that is intentional or unintentionally present in the device operation environment.  Testing is accomplished by exposing a medical device to a highly characterized and calibrated electromagnetic (EM) source.  To minimize reflections, the tests are conducted in specially prepared environments (i.e. anechoic chambers) where EM source reflections are absorbed.  More than 70 medical devices were tested in recent years in the Electromagnetics and Wireless Laboratory.  The devices were exposed to a wide range of field strengths and frequencies to characterize the effects of electromagnetic interference.  This testing provides key information about the potential electromagnetic interference effects that may occur and how these may impact the risks for device users that might encounter such exposure.  The results of this testing are directly applied to the development of standard test methodologies, safety limits, and are an integral part of the regulatory review process.  DP coordinates this activity amongst FDA/CDRH, and works closely with medical device manufacturers and other government agencies.

 


An FDA engineer performs electromagnetic compatibility testing with radio waves,
exposing a medical device in a special anechoic chamber.