EN IEC 60601-2-22:2020

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

IEC 60601-2-22:2019 is available as IEC 60601-2-22:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-22:2019 applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as Laser Product of Class 1C where the Enclosed Laser is of Class 3B or 4, or Class 3B, or Class 4. Medical Electrical Equipment or Medical Electrical Systems which incorporate lasers as sources of energy being transferred to the Patient or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. Laser Products for these applications classified as a Class 1, Class 1M, Class 2, Class 2M or Class 3R Laser Product, are covered by IEC 60825-1:2014 and by the general standard. If a clause or subclause is specifically intended to be applicable to ME Equipment only, or to ME Systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies to ME Equipment and to ME Systems, as relevant. Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. If the laser equipment is Class 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition; b) it addresses technical and safety issues which have arisen since publication of the third edition; c) the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4; d) LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57.

Medizinische elektrische Geräte - Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, kosmetische, therapeutische und diagnostische Lasergeräte

Appareils electromedicaux - Partie 2-22: Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laser

IEC 60601-2-22:2019 est disponible sous forme de IEC 60601-2-22:2019 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-22:2019 s'applique à la Sécurité de Base et aux Performances Essentielles des appareils à laser pour applications chirurgicales, thérapeutiques, de diagnostic médical, esthétiques ou vétérinaires destinés à être utilisés sur les personnes ou les animaux; ils sont classés comme Appareils à Laser de Classe 1C, le Laser Enfermé étant de Classe 3B ou 4, ou de Classe 3B, ou de Classe 4. Les Appareils Electromédicaux ou les Systèmes Electromédicaux intégrant des lasers comme sources d’énergie transférées au Patient ou à l’animal, les lasers étant conformes aux spécifications ci-dessus, sont désignés par le terme “appareils à laser” dans le présent document. Les Appareils à Laser pour ces applications, classés Appareils à Laser de Classe 1, Classe 1M, Classe 2, Classe 2M ou Classe 3R, sont couverts par l’IEC 60825-1:2014 et par la norme générale. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux Appareils EM ou uniquement aux Systèmes EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique aux Appareils EM et aux Systèmes EM, selon le cas. Les Dangers inhérents à la fonction physiologique prévue des appareils à laser dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document à l'exception de 7.2.13, Effets physiologiques, de la norme générale. Si les appareils à laser sont de la Classe 1C selon l’IEC 60825-1:2014 et sont utilisés en tant qu’appareil à laser pour un usage domestique, ils sont couverts par l’IEC 60335-2-113:2016. Cette quatrième édition annule et remplace la troisième édition parue en 2007 et l'Amendement 1:2012. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) elle prend en compte l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60825-1:2014, qui ont été publiés depuis la publication de la troisième édition; b) elle traite des questions techniques et de sécurité soulevées depuis la publication de la troisième édition; c) le domaine d’application de cette quatrième édition diffère de celui de la troisième édition. Il inclut désormais les appareils à laser de Classe 1C, tels que définis dans l’IEC 60825-1:2014, alors que le laser enfermé est un laser de Classe 3B ou 4; d) les appareils à LED (diode électroluminescente) sont à présent exclus du présent document étant donné que les appareils médicaux à LED peuvent être couverts par l’IEC 60601-2-57.

Medicinska električna oprema - 2-22. del: Posebne varnostne zahteve ter bistvene lastnosti kirurške, kozmetične, terapevtske in diagnostične laserske opreme

General Information

• Status: Published
• Publication Date: 29-Oct-2020
• ICS: 11.040.01 - Medical equipment in general
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: CLC/TC 76 - Optical radiation safety and laser equipment
• Drafting Committee: IEC/TC 76 - IEC_TC_76
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 30-Oct-2020
• Completion Date: 30-Oct-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN IEC 60601-2-22:2020 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Relations

• Replaces: 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
• Effective Date: 03-Nov-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2020
Nadomešča:
SIST EN 60601-2-22:2013
Medicinska električna oprema - 2-22. del: Posebne varnostne zahteve ter bistvene
lastnosti kirurške, kozmetične, terapevtske in diagnostične laserske opreme
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and
essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Medizinische elektrische Geräte - Teil 2-22: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für chirurgische, kosmetische,
therapeutische und diagnostische Lasergeräte
Appareils électromédicaux - Partie 2-22: Règles particulières pour la sécurité de base et
les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et
de diagnostic à laser
Ta slovenski standard je istoveten z: EN IEC 60601-2-22:2020
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
11.040.60 Terapevtska oprema Therapy equipment
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-22

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2020
ICS 11.040.01; 31.260 Supersedes EN 60601-2-22:2013 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-22: Particular requirements
for basic safety and essential performance of surgical, cosmetic,
therapeutic and diagnostic laser equipment
(IEC 60601-2-22:2019)
Appareils electromedicaux - Partie 2-22: Exigences Medizinische elektrische Geräte - Teil 2-22: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils chirurgicaux, esthétiques, wesentlichen Leistungsmerkmale für chirurgische,
thérapeutiques et de diagnostic à laser therapeutische und diagnostische Lasergeräte
(IEC 60601-2-22:2019) (IEC 60601-2-22:2019)
This European Standard was approved by CENELEC on 2019-12-25. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-22:2020 E

European foreword
The text of document 76/580/CDV, future edition 4 of IEC 60601-2-22, prepared by IEC/TC 76 "Optical
radiation safety and laser equipment" was submitted to the IEC-CENELEC parallel vote and approved
by CENELEC as EN IEC 60601-2-22:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-04-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-10-30
document have to be withdrawn
This document supersedes EN 60601-2-22:2013 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60601-2-22:2019 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60335-2-113:2016 NOTE Harmonized as EN 60335-2-113:—
IEC 61010-1 NOTE Harmonized as EN 61010-1
IEC 60947-3 NOTE Harmonized as EN 60947-3

Under preparation. Stage at time of publication: FprEN 60335-2-113:2019.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006/A12:2014 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
IEC 60825-1 2014 Safety of laser products - Part 1: EN 60825-1 2014
Equipment classification and requirements
- -  /AC 2017
IEC 60601-2-22 ®
Edition 4.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-22: Particular requirements for basic safety and essential performance

of surgical, cosmetic, therapeutic and diagnostic laser equipment

Appareils electromedicaux –
Partie 2-22: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils chirurgicaux, esthétiques,

thérapeutiques et de diagnostic à laser

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50; 11.040.60; 31.260 ISBN 978-2-8322-7586-3

– 2 – IEC 60601-2-22:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 20
201.12 Accuracy of controls and instruments and protection against HAZARDOUS
OUTPUTS . 20
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS . 23
Annexes . 24
Annex D (informative) Symbols on marking . 24
Annex AA (informative) Particular guidance and rationale . 26
Bibliography . 28
Index of defined terms used in this document . 29

Table D.1 – General symbols . 24

IEC 60601-2-22:2019 © IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-22: Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic
laser equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-22 has been prepared by IEC subcommittee 76: Optical
radiation safety and laser equipment.
This fourth edition cancels and replaces the third edition published in 2007 and
Amendment 1:2012. This edition constitutes a technical revision.
This edition includes
...