FDA Delays Conformance Date to IEC 60101 v3


FDA Extends Deadline for Conformity to IEC 60601-1 3rd Edition medical device electrical standard compliance to December 31, 2013.  The original date to demonstrate conformance was July 30, 2013.  This standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment.  After Dec 31, 2013, all submissions to the U.S. FDA for device approval must conform to version 3 of the standard.
Intertek has provided a guide that describes the changes from version 2, and includes a clause by clause review of the new standard.