20.60 Close of comment period May 14, 2024
CENELEC
CLC/TC 76 Optical radiation safety and laser equipment
European Norm
The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered).
These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
IN_DEVELOPMENT
FprEN IEC 60601-2-57:2023
IN_DEVELOPMENT
FprEN IEC 60601-2-57:2023/prAA
20.60
Close of comment period
May 14, 2024