EN 60601-2-22-2013 en Medical electrical equipment - Part 2-22 Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic la.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipmentBS EN 6

2、0601-2-22:2013National forewordThis British Standard is the UK implementation of EN 60601-2-22:2013. It is identical to IEC 60601-2-22:2007+A1:2012. It supersedes BS EN 60601-2-22:1996, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee EPL/76, Optical ra

3、diation safety and laser equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Insti

4、tution 2013.Published by BSI Standards Limited 2013. ISBN 978 0 580 53695 3 ICS 11.040.55; 11.040.60; 31.260Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 Fe

5、bruary 2013.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60601-2-22:2013EUROPEAN STANDARD EN 60601-2-22 NORME EUROPENNE EUROPISCHE NORM January 2013 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique

6、Europisches Komitee fr 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 Eng

7、lish 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 lectromdicaux - Partie 2-22: Rgles particulires pour la scurit de base

8、 et les performances essentielles des appareils chirurgicaux, esthtiques, thrapeutiques et de diagnostic laser (CEI 60601-2-22:2007 + A1:2012) Medizinische elektrische Gerte - Teil 2-22: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale fr chirurgische, kosmet

9、ische, therapeutische und diagnostische Lasergerte (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 o

10、f 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, Ge

11、rman). 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, Belgi

12、um, 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,

13、 Switzerland, Turkey and the United Kingdom. BS EN 60601-2-22:2013EN 60601-2-22:2013 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 safetyand laser equ

14、ipment“ were submitted to the IEC-CENELEC parallel vote and approved by CENELECas 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 bypublication of an identical nationalstandard or by

15、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. EN 60601-2-22:2013 includes the following significant technical changes with respect toEN 60601-2-22:1996: This th

16、ird edition takes account of the recently published new editions of the General StandardEN 60601-1 and Group safety publication EN 60825-1. Additionally, it addresses technical and safetyissues which have arisen in the time following the previous second edition. This standard is to be read in conjun

17、ction 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 oftables is al

18、so 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 ofall subdivis

19、ions (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 subclausesof Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. References to subclauses

20、 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 anycombination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of theISO/IEC Directives, Part 2.

21、For the purposes of this standard, the auxiliary verb: - “shall” means that compliance with a requirement or a test is mandatory for compliance with thisstandard; - “should” means that compliance with a requirement or a test is recommended but is not mandatoryfor compliance with this standard; - “ma

22、y” is used to describe a permissible way to achieve compliance with a requirement or test. BS EN 60601-2-22:2013EN 60601-2-22:2013 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicatesthat there is guidance or rationale related to that item in

23、Annex AA. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all suchpatent rights. This document has been prepared under a mandate given to CENELEC by the Europe

24、an Commissionand 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 thisdocument. Endorsement notice The text of the International Standards IEC 60601-2-22:2007

25、+ A1:2012 were approved by CENELECas 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 60664-3:200

26、3 (not modified). BS EN 60601-2-22:2013EN 60601-2-22:2013 Annex ZA (normative) Normative references to international publicationswith their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and areindispensable for its appli

27、cation. For dated references, only the edition cited applies. For undatedreferences, 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/HDapplies. Anne

28、x 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 classificationand requirements EN 60825-1 2007 IEC 60947-3 - Low-voltage switchgear and

29、 controlgear - Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units EN 60947-3 - IEC 61010-1 - Safety requirements for electrical equipment for measurement, controland laboratory use - Part 1: General requirements EN 61010-1 - BS EN 60601-2-22:2013EN 60601-2-22:2013 Annex

30、 ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and within its scope the standard covers allrelevant essential requirements as given in An

31、nex I of the EU Directive 93/42/EEC, except thefollowing: - 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 essentialrequirements of the Directives concerned. WARNING: Other requirements and other EU

32、Directives may be applicable to the products fallingwithin the scope of this standard. BS EN 60601-2-22:20136061-2 IEC:2007+A1:2012 CONTENTS 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

33、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 a

34、nd 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 condition

35、s 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 guidan

36、ce and rationale 22 Bibliography . 24 Index of defined terms used in this particular standard. 25 Table D.1 General symbols . 19 BS EN 60601-2-22:2013 6 60601-2-22 IEC:2007+A1:2012 INTRODUCTION This particular standard amends and supplements IEC 60601-1 (third edition, 2005: Medical Electrical Equip

37、ment 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 need to be complied with, in order to achieve a reasonable level of safety and reliability during operation and appli

38、cation 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 of the reasons for these requirements will not only facilitate the prop

39、er application of the standard but will, in due course, expedite any revisions necessitated by changes in clinical practice or by developments in technology. BS EN 60601-2-22:201360601-2-22 IEC:2007+A1:2012 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-22: Particular requirements for basic safety and essent

40、ial 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 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of las

41、er 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 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT. Throughout this

42、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 CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1 and IEC 60601-1. I

43、f 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 both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent

44、 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 be applied to surgic

45、al, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the safety of surgical

46、, cosmetic, therapeutic and diagnostic laser equipment. NOTE Laser classification (IEC 60825-1) must not be confused with electrical classification (IEC 60601-1). BS EN 60601-2-22:2013 8 60601-2-22 IEC:2007+A1:2012 201.1.3 Collateral standards Addition: This particular standard refers to those appli

47、cable collateral standards that are listed in Clause 2 of the General Standard and Clause 2 of this particular standard. IEC 60601-1-3 does not apply. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in this

48、standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the General Standard. For brevity, IEC 60601-1 is referred to in this particular standard as

49、the General Standard. Collateral standards are referred to by their document number. The numbering of sections, clauses and subclauses of this particular standard 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 particular standard. “Addition“ mea