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
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
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
PROJECT
nkSRPS EN IEC 61010-2-101:2023/AB:2023
30.99
CD approved for registration as DIS
Aug 22, 2024
PROJECT
prSRPS EN IEC 61010-2-101:2025