Acceptance Mark
IEC 60601-1, A2:2020
IEC 60601-1, A2:2020 Comparable Product Design Influencing Key Differences

IEC 60601-1, Edition A2 improves upon the requirements of previous editions by updating outdated material, providing additional definitions and correcting or clarifying technical issues. It incorporates a number of minor amendments (see table) that may cause previously certified equipment not to comply with the new edition.

IEC 60601-1, version A2 incorporates the standard requirements of IEC 62368-1:2018 as an alternative to IEC 60950-1:2005+AMD1:2009+AMD: 2013 as a means of electrical protection for operators (MOOP). This version of the standard replaces IEC 60950-1, which is no longer maintained, and will eventually lead to the discontinuation of IEC 60950-1 approved components in the market.


Other updated standard references include the following:

Risk Management: ISO 14971:2019
Medical device software: IEC 62304: 2006+AMD1: 2015 (IEC International Electrotechnical Society/International Electrotechnical Commission)
Rechargeable lithium batteries and battery packs: IEC 62133-2
Laser Laser Products: IEC 60825-1:2014
Parallel Standards: 2020 Edition