FDA는 2012년 6월 30일부터 2013년 12월 31일 까지 IEC 60601-1 3rd Edition의 과도기로 정하고,  이후에는 510(k), PMA, IDE, HDE, QSR, Design Controls Input 신청 시 적용되는 IEC 60601-1 Edition 2는 ANSI/AAMI ES60601-1:2005로 대체한다.

Publication Date: 01/14/2014

FDA recognition of Edition 2:1988 (A1:1991 + A2:1995) of IEC 60601-1 and its associated Part 1 collateral and Part 2 particular standards is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.
However, FDA will continue to accept declarations of conformity, in support of premarket submissions, to Edition 2:1988 (A1:1991 + A2:1995) of IEC 60601-1 and all its recognized Part 1 collateral and Part 2 particular standards until December 31, 2013.
Please note that this new transitional period is an extension from a previous date of June 30, 2013. After this extended transitional period, declarations of conformity to Edition 2:1988(A1:1991 + A2:1995) of IEC 60601-1 and all its recognized Part 1 collateral and Part 2 particular standards will not be accepted.