EN 60601-2-3-2015 en Medical electrical equipment - Part 2-3 Particular requirements for the basic safety and essential performance of short-wave therapy equipment (Incorporates Am.pdf

1、Medical electrical equipmentPart 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipmentBS EN 60601-2-3:2015BS EN 60601-2-3:2015+A1:2016(IEC 60601-2-3:2012)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN ST

2、ANDARDNORME EUROPENNEEUROPISCHE NORMEN 60601-2-3May 2015ICS 11.040.60 Supersedes EN 60601-2-3:1993English VersionMedical electrical equipment - Part 2-3: Particular requirementsfor the basic safety and essential performance of short-wavetherapy equipment(IEC 60601-2-3:2012)Appareils lectromdicaux -

3、Partie 2-3: Exigencesparticulires pour la scurit de base et les performancesessentielles des appareils de thrapie ondes courtes(IEC 60601-2-3:2012)Medizinische elektrische Gerte - Teil 2-3: BesondereFestlegungen fr die Sicherheit einschlielich derwesentlichen Leistungsmerkmale von Kurzwellen-Therapi

4、egerten(IEC 60601-2-3:2012)This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELECInternal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.-to-date lis

5、ts and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELECUpManagement 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 translationun

6、der the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has thesame status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,Latvia,Denmar

7、k, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,Turkey and the United Kingdom.European Committee for

8、Electrotechnical StandardizationComit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

9、Ref. No. EN 60601-2-3:2015 EBS EN 60601-2-3:2015BS EN 60601-2-3:2015+A1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 60601-2-3:2015+A1:2016. It is identical to IEC 60601-2-3:2012,incorporating amendment 1:2016. It supersedes BS EN 60601-2-3:2015 which wi

10、ll be withdrawn on 30 September 2019.The start and finish of text introduced or altered by amendment isindicated in the text by tags. Tags indicating changes to IEC text carrythe number of the IEC amendment. For example, text altered by IECamendment 1 is indicated by .The UK participation in its pre

11、paration was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of organizations represented on this subcommittee can beobtained on request to its secretary.This publication does not purport to include all the nece

12、ssary provisionsof a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 90074 7ICS 11.040.60Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was

13、 published under the authority of the StandardsPolicy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affected31 October 2016 Implementation of IEC amendment 1:2016 withCENELEC endorsement A1:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 6060

14、1-2-3 May 2015 ICS 11.040.60 Supersedes EN 60601-2-3:1993 English Version Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (IEC 60601-2-3:2012) Appareils lectromdicaux - Partie 2-3: Exigences particulires

15、pour la scurit de base et les performances essentielles des appareils de thrapie ondes courtes (IEC 60601-2-3:2012) Medizinische elektrische Gerte - Teil 2-3: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Kurzwellen-Therapiegerten (IEC 60601-2-3:2012)

16、This European Standard was approved by CENELEC on 2015-04-14. 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

17、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

18、 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, Forme

19、r 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. European Committee for Electrotechnica

20、l Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN

21、 60601-2-3:2015 E BS EN 60601-2-3:2015EN 60601-2-3:2015+A1September 2016EN 60601-2-3:2015 (E) 2 Foreword The text of document 62D/977/FDIS, future edition 3 of IEC 60601-2-3, prepared by SC 62D, “Electromedical equipment“, of IEC TC 62, “Electrical equipment in medical practice“ was submitted to the

22、 IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-3:2015. 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) 2016-01-14 latest date by which the national stan

23、dards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-3:1993 + A1:1998. 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 i

24、dentifying 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 see informative Annex ZZ, whic

25、h is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-3:2012 was approved by CENELEC as a European Standard without any modification. BS EN 60601-2-3:2015 2 BS EN 60601-2-3:2015+A1:2016EN 60601-2-3:3015+A1:2016 (E)EN 60601-2-3:2015 (E) 2 Forewo

26、rd The text of document 62D/977/FDIS, future edition 3 of IEC 60601-2-3, prepared by SC 62D, “Electromedical equipment“, of IEC TC 62, “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-3:2015. The following dates are fixed

27、: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN

28、60601-2-3:1993 + A1:1998. 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 CEN

29、ELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC

30、60601-2-3:2012 was approved by CENELEC as a European Standard without any modification. BS EN 60601-2-3:2015 3 BS EN 60601-2-3:2015+A1:2016EN 60601-2-3:3015+A1:2016 (E)EN 60601-2-3:2015/A1:2016 2 European foreword The text of document 62D/1330/FDIS, future IEC 60601-2-3:2012/A1, prepared by SC 62D “

31、Electromedical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-3:2015/A1:2016. The following dates are fixed: latest date by which the document has to be implemented at national level by publicat

32、ion of an identical national standard or by endorsement (dop) 2017-03-30 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2019-09-30 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent right

33、s. 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 rela

34、tionship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-3:2015. Endorsement notice The text of the International Standard IEC 60601-2-3:2012/A1:2016 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1EN 60601-2-3:2015 (E) 3

35、 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 given

36、 in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products fa

37、lling within the scope of this standard. BS EN 60601-2-3:2015 2 60601-2-3 IEC:2012 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 7 201.3 Terms and definitions 7 201.4 General requirements 8 201.5 General requirements for testing of ME

38、 EQUIPMENT . 8 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 8 201.7 ME EQUIPMENT identification, marking and documents 8 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 10 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against u

39、nwanted and excessive radiation HAZARDS 14 201.11 Protection against excessive temperatures and other HAZARDS 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs 14 201.13 HAZARDOUS SITUATIONS and fault conditions. 15 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

40、 (PEMS) 16 201.15 Construction of ME EQUIPMENT . 16 201.16 ME SYSTEMS 16 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16 Annexes . 16 ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 17 Annex AA (informative) Particular guidan

41、ce and rationale 18 Index of defined terms used in this particular standard 20 Figure 201.101 Dielectric strength test for capacitive APPLICATORS . 12 Figure 201.102 Test probe . 13 Figure 201.103 Dielectric strength test for inductive APPLICATORS 14 BS EN 60601-2-3:2015 4 BS EN 60601-2-3:2015+A1:20

42、16EN 60601-2-3:3015+A1:2016 (E) 2 60601-2-3 IEC:2012 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 7 201.3 Terms and definitions 7 201.4 General requirements 8 201.5 General requirements for testing of ME EQUIPMENT . 8 201.6 Classific

43、ation of ME EQUIPMENT and ME SYSTEMS 8 201.7 ME EQUIPMENT identification, marking and documents 8 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 10 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against unwanted and excessive radiatio

44、n HAZARDS 14 201.11 Protection against excessive temperatures and other HAZARDS 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs 14 201.13 HAZARDOUS SITUATIONS and fault conditions. 15 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 16 201.15 Construction

45、 of ME EQUIPMENT . 16 201.16 ME SYSTEMS 16 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16 Annexes . 16 ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 17 Annex AA (informative) Particular guidance and rationale 18 Index of d

46、efined terms used in this particular standard 20 Figure 201.101 Dielectric strength test for capacitive APPLICATORS . 12 Figure 201.102 Test probe . 13 Figure 201.103 Dielectric strength test for inductive APPLICATORS 14 BS EN 60601-2-3:2015BS EN 60601-2-3:2015+A1:2016IEC 60601-2-3:2012+A1:2016 5 Ha

47、zardous situations and fault conditions for me equipment689101011111111131717171718191919191920212315161760601-2-3 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therap

48、y 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 standardiz

49、ation 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-gover