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IEC 60601-2-22
Edition 4.0 2019-11
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-22: Particular requirements for basic safety and essential performance
of surgical, cosmetic, therapeutic and diagnostic laser equipment
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IEC 60601-2-22
Edition 4.0 2019-11
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-22: Particular requirements for basic safety and essential performance
of surgical, cosmetic, therapeutic and diagnostic laser equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50; 11.040.60; 31.260 ISBN 978-2-8322-7650-1
– 2 – IEC 60601-2-22:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 Accuracy of controls and instruments and protection against HAZARDOUS
OUTPUTS . 23
201.13 HAZARDOUS SITUATIONS and fault conditions for me equipment . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
201.15 Construction of ME EQUIPMENT . 27
201.16 ME SYSTEMS . 28
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS . 28
Annexes . 29
Annex D (informative) Symbols on marking . 29
Annex AA (informative) Particular guidance and rationale . 30
Bibliography . 33
Index of defined terms used in this document . 34
Table D.1 – General symbols . 29
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
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
– 4 – IEC 60601-2-22:2019 RLV © IEC 2019
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;
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.
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.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-22:2019 RLV © 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 60825-1:20072014. 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
...