10.99 New project approved Apr 12, 2023
CENELEC
CLC/TC 66X Safety of measuring, control, and laboratory equipment
European Norm
The scope of the Amendment A12 is the same as EN 61010-2-101:2022. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
A12 shall include Annex zz to achieve harmonization under the IVD Regulation 746/2017/EU
Legislation related to this standard
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
PUBLISHED
EN IEC 61010-2-101:2022
IN_DEVELOPMENT
EN IEC 61010-2-101:2022/prAB
10.99
New project approved
Apr 12, 2023