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EN IEC 61010-2-101:2022/prAB

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101 Particular requirements for in vitro diagnostic (IVD) medical equipment

General information

30.99 CD approved for registration as DIS   Aug 22, 2024

CENELEC

CLC/TC 66X Safety of measuring, control, and laboratory equipment

European Norm

11.040.55   Diagnostic equipment | 19.080   Electrical and electronic testing

Scope

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

Related legislation

Legislation related to this standard

2017/746

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

Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN IEC 61010-2-101:2022

NOW

IN_DEVELOPMENT
EN IEC 61010-2-101:2022/prAB
30.99 CD approved for registration as DIS
Aug 22, 2024