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SRPS EN IEC 60601-2-57:2026/A11:2026

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

Jul 31, 2026

General information

60.60     Jul 31, 2026

ISS

N062

European Norm

11.040.50     11.040.60  

English  

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Scope

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.

Related directives

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.

2017/745

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

Directive 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN IEC 60601-2-57:2026

NOW

PUBLISHED
SRPS EN IEC 60601-2-57:2026/A11:2026
60.60 Standard published
Jul 31, 2026

REVISED BY

PROJECT
prSRPS EN IEC 60601-2-57:2026

Related project

Adopted from EN IEC 60601-2-57:2026/A11:2026 IDENTICAL