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FprEN IEC 60601-2-57:2023/prAA:2025

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

Draft Public enquiry
Comment end date 2025-08-08
Export comments Read draft and comment

Project stage codes

1. Decision on WI Proposal
2. Viešoji apklausa
From 2025-06-09 till 2025-08-08

Organisation

CENELEC Europos elektrotechnikos standartizacijos komitetas

ICS

11.040.60 - Therapy equipment

ForeignTC'S

CLC/TC 76

Number of comments

0

Comment start date

2025-06-09

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.

Relations

Pagrindinis
FprEN IEC 60601-2-57:2023

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 and cosmetic/aesthetic use