4th Edition of Electromagnetic Compatibility Standard Accepted

The International Electrotechnical Commission (IEC) introduces the fourth edition of the IEC 60601-1-2:2014 standard, which is a standard specifying electromagnetic compatibility (EMC) requirements. This revision introduces technical changes including new immunity and risk analysis requirements.


The new revision offers higher EMC test levels and a new wireless proximity test that increases radiated immunity test levels. “Additionally, the revision recognizes that RF wireless communications equipment can no longer be prohibited from most patient environments because it is often essential to the healthcare delivery. It acknowledges that for special environments, immunity test levels higher or lower than those specified for the professional healthcare and home environments might be appropriate.”


TÜV Rheinland, a global certification organization, advices medical device manufacturers to note the new EMC requirements.  New devices must comply with this revised standard by April 2017 in the U.S and by August 2017 in Europe. The Food and Drug Administration (FDA) has already accepted the new edition.


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