SIST EN IEC 60601-2-22:2020/A11:2026

SLOVENSKI STANDARD
01-marec-2026
Medicinska električna oprema - 2-22. del: Posebne varnostne zahteve ter bistvene
lastnosti kirurške, kozmetične, terapevtske in diagnostične laserske opreme -
Dopolnilo A11
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: Exigences 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/A11:2026
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 60601-2-22:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2026
ICS 11.040.01; 31.260
English Version
Medical electrical equipment - Part 2-22: Particular requirements
for basic safety and essential performance of surgical, cosmetic,
therapeutic and diagnostic laser equipment
Appareils électromédicaux - 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 kosmetische, therapeutische und diagnostische
Lasergeräte
This amendment A11 modifies the European Standard EN IEC 60601-2-22:2020; it was approved by CENELEC on 2025-12-17. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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,
Türkiye 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
© 2026 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/A11:2026 E

Contents Page
European foreword . 3
Annex ZA (normative) Normative references to international publications with their corresponding
European publications . 4
Annex ZZ (informative) Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 5
European foreword
This document (EN IEC 60601-2-22:2020/A11:2026) has been prepared by CLC/TC 76 "Optical radiation safety
and laser equipment”.
The following dates are fixed:
• latest date by which this document has to be (dop) 2027-01-31
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) 2029-01-31
conflicting with this document have to be
withdrawn
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.
This document has been prepared under a standardization request addressed to CENELEC by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part of this document.
Collateral standards in the IEC 60601 series are numbered IEC 60601-1-xx. The IEC maintains a catalogue of
valid International Standards. Users of this document can consult this catalogue at "http://webstore.iec.ch" to
determine which collateral standards have been published.
Any feedback and questions on this document should be directed to the users’ national committee. A complete
listing of these bodies can be found on the CENELEC website.
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.cencenelec.eu.
The Annex ZA of EN 60601-1:2006/A13:2024 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: General EN 60601-1 2006
requirements for basic safety and essential
performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
+ A1:2013/AC 2014
- - + A12 2014
+ A2 2021
+ AC 2022-
+ A13 2024
IEC 60825-1 2014 Safety of laser products - Part 1: Equipment EN 60825-1 2014
classification and requirements
- - + AC 2017-
+ A11 2021
+ A11:2021/AC 2022-
SIST EN IEC 60601-2-22:2020/A11:2
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