The 4th edition of the medical EMC standard IEC 60601-1-2:2014 becomes mandatory in the United States and the European Union from December 31st 2018 onwards. This new edition will have a major impact to the medical industry and presents several challenges to minimize the risks caused by electromagnetic disturbances. In addition to the more stringent immunity test levels, risk management of electromagnetic disturbances (including reliable wireless connections) has become a mandatory compliance requirement over the operational lifetime of a medical device. In this presentation an overview will be given of the different process steps to manage the risks caused by electromagnetic disturbances.
Marcel van Doorn, Philips Innovation Services – EMC consultancy