Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

dnaSRPS EN 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, cosmetic and aesthetic use

General information

50.60     Jun 30, 2023

ISS

N062

European Norm

11.040.50     11.040.60  

English  

Scope

IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).

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.

93/42/EEC

Medical devices

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

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN 60601-2-57:2012

NOW

PROJECT
dnaSRPS EN IEC 60601-2-57:2023
50.60 Close of voting. Proof returned by secretariat
Jun 30, 2023

CORRIGENDA / AMENDMENTS

PROJECT
naSRPS EN IEC 60601-2-57:2023/AA:2025

Related project

Adopted from FprEN IEC 60601-2-57:2023

Adopted from IEC 60601-2-57:2023 ED2 IDENTICAL