EMC for Medical Devices: EN/IEC 60601-1-2, 4th Edition

The fourth edition IEC/EN 60601-1-2 (4th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.1,2 As with any new standard edition, there are changes that necessitate additional evaluations of the product beyond those required by the previous edition. Although emission and immunity tests for medical products are very similar to those applied to other product types, such as radio equipment, networking equipment and multimedia equipment, IEC 60601-1-2 requires that basic safety and essential performance of the medical device be maintained as opposed to the EMC compliance for other type of products. This is reflected in the title of 4th edition.