EN 60601-2-22:2013

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, therapeutische und diagnostische LasergeräteAppareils électromédicaux - Partie 2-22: Règles particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laserMedical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment31.260Optoelektronika, laserska opremaOptoelectronics. Laser equipment11.040.60Terapevtska opremaTherapy equipment11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-22:2013SIST EN 60601-2-22:2013en01-marec-2013SIST EN 60601-2-22:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD EN 60601-2-22 NORME EUROPÉENNE
EUROPÄISCHE NORM January 2013
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2013 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-22:2013 E
ICS 11.040.01; 31.260 Supersedes EN 60601-2-22:1996
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 60601-2-22:2007 + A1:2012)
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 (CEI 60601-2-22:2007 + A1:2012)
Medizinische elektrische Geräte -
Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, kosmetische, therapeutische
und diagnostische Lasergeräte (IEC 60601-2-22:2007 + A1:2012)
This European Standard was approved by CENELEC on 2012-11-29. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Foreword The texts of document 76/359/FDIS, future edition 3 of IEC 60601-2-22, and document 76/444/CDV, future amendment 1 to edition 3 of IEC 60601-2-22, prepared by IEC/TC 76 "Optical radiation safety and laser equipment" were submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-22:2013, based on IEC 60601-2-22:2007 + A1:2012.
The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-08-29 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2015-11-29
This document supersedes EN 60601-2-22:1996.
This standard is to be read in conjunction with EN 60601-1:2006.
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. SIST EN 60601-2-22:2013

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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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standards IEC 60601-2-22:2007 + A1:2012 were approved by CENELEC as a European Standard without any modification. The Bibliography of EN 60601-1:2006 applies, except as follows:
In the Bibliography of EN 60601-1:2006, the following note has to be added for the standard indicated:
IEC 60664-3:2003 NOTE Harmonised as EN 60664-3:2003 (not modified).
Annex ZA
(normative)
Normative references to international publications with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE
When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year Add to Annex ZA of EN 60601-1:2006 the following new references: IEC 60825-1 2007 Safety of laser products -
Part 1: Equipment classification
and requirements EN 60825-1 2007
IEC 60947-3 - Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors,
switch-disconnectors and fuse-combination units EN 60947-3 -
IEC 61010-1 - Safety requirements for electrical
equipment for measurement, control
and laboratory use -
Part 1: General requirements EN 61010-1 -
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Annex ZZ (informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EU Directive 93/42/EEC, except the following:
- ER 1 to ER 7.1 - ER 7.4 - ER 7.5, Paragraph 2 and 3 - ER 13.6 (q)
Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive[s] concerned.
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard.
IEC 60601-2-22 Edition 3.1 2012-10 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 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
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.01, 31.260 ISBN 978-2-8322-0443-6
– 2 – 60601-2-22  IEC:2007+A1:2012 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 . 11 201.5 General requirements for testing ME EQUIPMENT . 11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11 201.7 ME EQUIPMENT identification, marking and documents . 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against unwanted and excessive radiation HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16 201.13 HAZARDOUS SITUATIONS and fault conditions . 17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18 201.15 Construction of ME EQUIPMENT . 18 201.16 ME SYSTEMS. 19 201.17 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+A1:2012 – 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 mi
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