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БДС EN 60601-2-22:2013

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Feb 15, 2013
Oct 17, 2016

General information

90.93     Oct 26, 2022

99.60    Oct 30, 2023

October 2023



European Standard

11.040.01     31.260     11.040.50     11.040.60     31.26  

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Applies to the basic safety and essential performance of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a class 3B or class 4 laser product as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as laser equipment. Throughout this International Standard, light emitting diodes (LED) are included whenever the word 'laser' is used. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition of IEC 60601-2-22, published in 1995. This edition constitutes a technical revision. This third edition takes account of the recently published new editions of the General Standard IEC 60601-1 and Group safety publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.

Directives and Regulations

When the standard is harmonized under a directive or regulation, the word Harmonized appear. When such an inscription does not appear, it means that the standard is related to / supporting the relevant directive or regulation.


Medical devices

Life cycle


БДС EN 60601-2-22:2004


БДС EN 60601-2-22:2013
90.93 Standard confirmed
Oct 26, 2022


prБДС EN 60601-2-22:2007/A1:2011


БДС EN IEC 60601-2-22:2021

Related project

Adopted from EN 60601-2-22:2013

Adopted from IEC 60601-2-22:2007/AMD1:2012 ED3

Adopted from IEC 60601-2-22:2007 ED3