New Medical Device EMC Requirements

Implementation of IEC 60601-1-2, 4th edition is on the horizon. This collateral standard to the IEC 60601-1 medical safety standard specifies the electromagnetic compatibility (EMC) requirements for medical devices and systems. The fourth edition was issued by the International Electrotechnical Commission (IEC) in February 2014. The FDA is requiring compliance for new products after April 1, 2017, and in Europe, the EN 60601-1-2:2007 3rd edition withdrawal date is currently set for December 31, 2018. It is expected that the EN 60601-1-2:2015 (4th) edition will be in effect in the EU before that date.