On July 9, 2014, the FDA added the 4th edition of IEC 60601-1-2, “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests” to the list of standards that can be used to show EMC compliance for medical electrical devices and systems. As of August 1, 2016 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007-03 or ANSI/AAMI/IEC 60601-1-2:2007/(R)2012. In addition it should be noted that the FDA will not accept the Signal Input/Signal Output (Sip/Sop) exemption for disturbances induced by RF fields for cables with a length less than 3-meters.
This recognition affects All Electrical Medical Devices, Except for Active Implanted Devices.
For additional information, please contact G&M Compliance at 714-628-1020.