IEC 60601-2-22:2007

INTERNATIONAL IEC
STANDARD
CEI
60601-2-22
NORME
Third edition
INTERNATIONALE
Troisième édition
2007-05
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:
Règles particulières pour la sécurité de base
et les performances essentielles des appareils
chirurgicaux, esthétiques, thérapeutiques et de
diagnostic à laser
Reference number
Numéro de référence
IEC/CEI 60601-2-22:2007
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INTERNATIONAL IEC
STANDARD
CEI
60601-2-22
NORME
Third edition
INTERNATIONALE
Troisième édition
2007-05
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:
Règles particulières pour la sécurité de base
et les performances essentielles des appareils
chirurgicaux, esthétiques, thérapeutiques et de
diagnostic à laser
PRICE CODE
U
CODE PRIX
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
Pour prix, voir catalogue en vigueur

– 2 – 60601-2-22 © IEC:2007
CONTENTS
FOREWORD.3

INTRODUCTION.5

201.1 Scope, object and related standards.6

201.2 Normative references .8

201.3 Terms and definitions .8

201.4 General requirements.10

201.5 General requirements for testing ME EQUIPMENT.10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .10
201.7 ME EQUIPMENT identification, marking and documents.10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.13
201.10 Protection against unwanted and excessive radiation HAZARDS.13
201.11 Protection against excessive temperatures and other HAZARDS.15
201.12 Accuracy of controls and instruments and protection against hazardous outputs .15
201.13 HAZARDOUS SITUATIONS and fault conditions .16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .18
201.15 Construction of ME EQUIPMENT .18
201.16 ME SYSTEMS.18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.19

Annexes .19
Annex D (informative) Symbols on marking.19
Annex AA (informative) Particular guidance and rationale.22

Bibliography.24
Index of defined terms used in this particular standard.25

Table D.1 – General symbols.19

60601-2-22 © IEC:2007 – 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
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5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
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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 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.
– 4 – 60601-2-22 © IEC:2007
The text of this particular standard is based on the following documents:

FDIS Report on voting
76/359/FDIS 76/363/RVD
Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

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

In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
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
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
60601-2-22 © I
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