IEC60601-1 在2012年又有補充規範 改為3.1版

http://60601-1.com/information.html

US FDA deadline for compliance with AAMI ES 60601-1:2005(R)2012+A1:2012
    (Third Edition with Amendment 1) 2016-08-01, per FDA
    Required for new medical equipment and existing equipment requiring FDA re-submission

European Union deadline for compliance with EN 60601-1, Ed.3 + Am.1    (Third Edition with Amendment 1) 2018-01-01, per EU OJ
    Required for all medical equipment on the market (no grandfathering)

依照網頁說明FDA最快在2016/8/1 就要強制實施,CE則是要到2018/1/1才會要求