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

This part of IEC 60601 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.
NOTE 1 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.

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

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
19-Nov-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
12-Nov-2020
Due Date
17-Jan-2021
Completion Date
20-Nov-2020

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-22:2020
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
SIST EN IEC 60601-2-22:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-22:2020
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-22:2020
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
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SIST EN IEC 60601-2-22:2020
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.
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SIST EN IEC 60601-2-22:2020
EN IEC 60601-2-22:2020 (E)
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
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SIST EN IEC 60601-2-22:2020
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SIST EN IEC 60601-2-22:2020
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN IEC 60601-2-22:2020
– 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

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SIST EN IEC 60601-2-22:2020
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 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;
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SIST EN IEC 60601-2-22:2020
– 4 – IEC 60601-2-22:2019 © IEC 2019

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.
The text of this International Standard is based on the following documents:
CDV Report on voting
76/580/CDV 76/610/RVC

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:
• requirements and definitions: roman type;
• test specifications: italic type;

• informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type.

• TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term

• “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

• “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this document are preceded by the term “Clause” followed by

the clause number. References to subclauses within this document are by number only.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to usage described in Clause 7 of the

ISO/IEC Directives, Part 2:2018. For the purposes of this document, the auxiliary verb:

• “shall” means that compliance with a requirement or a test is mandatory for compliance

with this document;

• “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this document;

• “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

A list of all parts of the IEC 60601 and IEC 80601 series, published under the general title

Medical electrical equipment, can be found on the IEC website.
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SIST EN IEC 60601-2-22:2020
IEC 60601-2-22:2019 © IEC 2019 – 5 –

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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SIST EN IEC 60601-2-22:2020
– 6 – IEC 60601-2-22:2019 © IEC 2019
INTRODUCTION
This document amends and supplements IEC 60601-1:2005 and IEC 60601-

1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance.

This document also refers to IEC 60825-1:2014. The requirements of this document are the

minimum that need to be complied with, in order to achieve a reasonable level of safety and

reliability during operation and application of medical laser equipment.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA. Understanding

the reasons for these requirements will not only facilitate the proper application of this

document but will, in due course, expedite any revisions necessitated by changes in clinical

practice or by developments in technology.
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SIST EN IEC 60601-2-22:2020
IEC 60601-2-22:2019 © IEC 2019 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-22: Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic
laser equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:

This part of IEC 60601 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.

NOTE 1 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

ME EQUIPMENT and to ME SYSTEMS, as relevant.
case, the clause or subclause applies to

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.
NOTE 2 See also 4.2, RISK MANAGEMENT process, of the general standard.

NOTE 3 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.
201.1.2 Object
Replacement:

The object of this document is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for the safety of surgical, cosmetic, therapeutic and diagnostic

laser equipment.
201.1.3 Collateral standards
Addition:

This document refers to those applicable collateral standards that are listed in Clause 2 of the

general standard and Clause 201.2 of this document.
—————————

In this document, "the general standard" means IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

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SIST EN IEC 60601-2-22:2020
– 8 – IEC 60601-2-22:2019 © IEC 2019
201.1.4 Particular standards
Addition:

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this

document as "the general standard". Collateral standards are referred to by their document

number.

The numbering of sections, clauses and subclauses of this document corresponds to that of

the general standard or applicable collateral standard. The changes to the text of the general

standard are specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this document.

"Addition" means that the text of this document is additional to the requirements of the

general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this document.

Subclauses or figures which are additional to those of the general standard are numbered

starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa),

bb), etc.

Subclauses or figures which are additional to those of a collateral standard are numbered

starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this document" is used to make reference to the general standard, any applicable

collateral standards and this document taken together.

Where there is no corresponding section, clause or subclause in this document, the section,

clause or subclause of the general standard or applicable collateral standard, although

possibly not relevant, applies without modification; where it is intended that any part of the

general standard or applicable collateral standard, although possibly relevant, is not to be

applied, a statement to that effect is given in this document.

Concerning laser radiation safety of laser equipment, IEC 60825-1:2014 applies, except for

the relevant requirements that are specified, changed or amended in this document.

201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Addition:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
IEC 60601-1:2005/AMD1:2012

IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and

requirements
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SIST EN IEC 60601-2-22:2020
IEC 60601-2-22:2019 © IEC 2019 – 9 –
201.3 Terms and definitions
Clause 3 of the general standard applies, except as follows:
Addition:
201.3.201
AEL
ACCESSIBLE EMISSION LIMIT

maximum accessible emission permitted within a particular class where the accessible

emission is the level of radiation determined at a position and with APERTURE stops (when the

AEL is given in units of watts or joules) or limiting APERTURES (when the AEL is given in units

-2 -2
of W·m or J·m )
[SOURCE: IEC 60825-1:2014, 3.2 and 3.3, modified – The two definitions have been
combined into one.]
201.3.202
AIMING BEAM

beam of optical radiation, producing a visible spot, intended for indication of the anticipated

point of impact of the WORKING BEAM
201.3.203
AIMING LASER
laser emitting an AIMING BEAM
201.3.204
APERTURE

opening of the BEAM DELIVERY SYSTEM through which laser radiation is transmitted, thereby

allowing human access to such radiation

[SOURCE: IEC 60825-1:2014, 3.8, modified – In the definition, "any opening in the

protective housing of a laser product" has been replaced by "opening of the BEAM DELIVERY

SYSTEM".]
201.3.205
BEAM DELIVERY SYSTEM

optical system which guides the laser radiation from its origin to the WORKING AREA

201.3.206
CLASS 1C

class of any LASER PRODUCT which is designed explicitly for contact application to the skin or

non-ocular tissue

[SOURCE: IEC 60825-1:2014, 3.19, modified – The list and notes to entry have been

deleted.]
201.3.207
CLASS 2

class of any LASER PRODUCT in the wavelength range from 400 nm to 700 nm which during

operation does not permit human access to laser radiation in excess of the AEL of CLASS 2

[SOURCE: IEC 60825-1:2014, 3.21, modified – In the definition, "for applicable wavelengths

and emission durations" and the text in parentheses have been deleted.]
201.3.208
CLASS 3B

class of any LASER PRODUCT which during operation permits human access to laser radiation

in excess of the AEL of Class 1 and CLASS 2, as applicable, but which does not permit human

access to laser radiation in excess of the AEL of CLASS 3B for any emission duration and

wavelength
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SIST EN IEC 60601-2-22:2020
– 10 – IEC 60601-2-22:2019 © IEC 2019

[SOURCE: IEC 60825-1:2014, 3.23, modified – The term and definition have been modified

to refer only to CLASS 3B. In the definition, the text in parentheses has been deleted.]

201.3.209
CLASS 3R

class of any LASER PRODUCT which during operation permits human access to laser radiation

in excess of the AEL of Class 1 and CLASS 2, as applicable, but which does not permit human

access to laser radiation in excess of the AEL of CLASS 3R for any emission duration and

wavelength

[SOURCE: IEC 60825-1:2014, 3.23, modified – The term and definition have been modified

to refer only to CLASS 3R. In the definition, the text in parentheses has been deleted.]

201.3.210
CLASS 4

class of any LASER PRODUCT which permits human access to laser radiation in excess of the

AEL of CLASS 3B

[SOURCE: IEC 60825-1:2014, 3.24, modified – In the definition, the text in parentheses has

been deleted.]
201.3.211
EMERGENCY LASER STOP

hand- or foot-actuated device intended to stop the LASER OUTPUT immediately in case of

emergency
201.3.212
ENCLOSED LASER
laser which is incorporated in laser equipment of CLASS 1C
201.3.213
GOOD CONTACT

state that is established when the applicator of the laser equipment which is classified laser

CLASS 1C is positioned at the target tissue so that the tissue surface acts to effectively

STRAY OPTICAL RADIATION
prevent hazardous eye exposure to
[SOURCE: IEC 60335-2-113:2016, 3.104, modified]
201.3.214
LASER EMISSION CONTROL SWITCH

hand- or foot-actuated device intended to initiate and stop WORKING BEAM emission

201.3.215
LASER EMISSION INDICATOR

visible and/or audible signal which indicates that the WORKING BEAM is being emitted

Note 1 to entry: Refer to IEC 60825-1:2014, 6.7 Laser radiation emission warning.

201.3.216
LASER ENERGY
LASER OUTPUT

RADIANT ENERGY of the WORKING BEAM, incident on the WORKING AREA, where the RADIANT

ENERGY is the time integral of the radiant flux Φ over a given duration ∆t

Note 1 to entry: LASER OUTPUT is a more general term which covers both LASER POWER and LASER ENERGY.

[SOURCE: IEC 60825-1:2014, 3.72, modified – In the definition, “RADIANT ENERGY of the

WORKING BEAM, incident on the WORKING AREA, where the RADIANT ENERGY is the”]
201.3.217
LASER OPERATOR
person handling the laser equipment.
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Note 1 to entry: In general, the LASER OPERATOR controls the delivery of the laser radiation to the WORKING AREA.

The LASER OPERATOR may appoint other person(s), who assist with the selection and/or setting of the parameters.

[SOURCE: IEC 60601-1:2012, 3.73, modified – The word "laser" has been added in the term

and definition.]
201.3.218
LASER POWER
LASER OUTPUT

RADIANT POWER of the WORKING BEAM, incident on the WORKING AREA where the RADIANT POWER

is the power emitted, transferred, or received in the form of radiation

Note 1 to entry: LASER OUTPUT is a more general term which covers both LASER POWER and LASER ENERGY.

[SOURCE: IEC 60825-1:2014, 3.74, modified – In the term, "radiant" has been replaced by

"laser".
...

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