1、 INTERNATIONAL STANDARD IECCEINORME INTERNATIONALE60601-2-22Third editionTroisime dition2007-05Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Appareils lectromdicaux Partie 2
2、22: Rgles particulires pour la scurit de base et les performances essentielles des appareils chirurgicaux, esthtiques, thrapeutiques et de diagnostic laser Reference number Numro de rfrence IEC/CEI 60601-2-22:2007 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All r
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15、ARD IECCEINORME INTERNATIONALE60601-2-22Third editionTroisime dition2007-05Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Appareils lectromdicaux Partie 2-22: Rgles particuli
16、res pour la scurit de base et les performances essentielles des appareils chirurgicaux, esthtiques, thrapeutiques et de diagnostic laser For price, see current cataloguePour prix, voir catalogue en vigueur PRICE CODE CODE PRIX U Commission Electrotechnique InternationaleInternational Electrotechnica
17、l Commission 2 60601-2-22 IEC:2007 CONTENTS FOREWORD.3 INTRODUCTION.5 201.1 Scope, object and related standards6 201.2 Normative references 8 201.3 Terms and definitions 8 201.4 General requirements10 201.5 General requirements for testing ME EQUIPMENT.10 201.6 Classification of ME EQUIPMENT and ME
18、SYSTEMS 10 201.7 ME EQUIPMENT identification, marking and documents10 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS13 201.10 Protection against unwanted and excessive radiation HAZARDS13 201.11 Protection a
19、gainst excessive temperatures and other HAZARDS15 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 S
20、YSTEMS.18 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS19 Annexes .19 Annex D (informative) Symbols on marking19 Annex AA (informative) Particular guidance and rationale22 Bibliography24 Index of defined terms used in this particular standard25 Table D.1 General symbols19 60601
21、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
22、 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
23、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 t
24、he 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 conditi
25、ons 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 Nation
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27、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 P
28、ublication and the corresponding national or regional publication shall be clearly indicated in the latter. 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 ens
29、ure 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
30、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 re
31、ferenced 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. Int
32、ernational 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
33、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
34、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
35、 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. T
36、ERMS 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 includ
37、es 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 st
38、andard 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
39、 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 per
40、missible 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 public
41、ation 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 IEC:2007 5 IN
42、TRODUCTION This particular standard amends and supplements IEC 60601-1 (third edition, 2005: Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance). This standard also refers to IEC 60825-1 (2007). The requirements of this standard are the minimum that
43、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 re
44、lated to that item in Annex AA. Understanding of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revisions necessitated by changes in clinical practice or by developments in technology. 6 60601-2-22 IEC:2007 MED
45、ICAL 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:
46、This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by
47、3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT. Throughout this International Standard, light emitting diodes (LED) are included whenever the word “laser” is used. NOTE 1 Refer to Definition 3.49 in IEC 60825-1. NOTE 2 Laser products for these applications classified as a CLA
48、SS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1 and IEC 60601-1. 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
49、 subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the General Standard. NOTE See also 4.2 of the General Standard. This standard can also
