BS EN 60601-2-8-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MVBS EN 60601-2-8:2015BS EN 60601-2-8:2015+A1:2016BS EN 60601-2-8:2015+A1:2016 BRITISH STANDARDNation

2、al forewordThis British Standard is the UK implementation of EN 60601-2-8:2015+A1:2016. It is identical to IEC 60601-2-8:2010, incorporating amendment 1:2015. It supersedes BS EN 60601-2-8:2015, which will be withdrawn on 3 November 2018.The start and finish of text introduced or altered by amendmen

3、t is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, t

4、o Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are respons

5、ible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 87721 6ICS 11.040.50Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standard

6、s Policy and Strategy Committee on 31 July 2015.Amendments/corrigenda issued since publicationDate Text affected29 February 2016 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2016EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 60601-2-8 June 2015 ICS 11.040.50 Supersedes EN 60

7、601-2-8:1997 English Version Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:2010) Appareils lectromdicaux - Partie 2-8: Exigencesparticulires pour la sc

8、urit de base et les performances essentielles des quipements rayonnement X de thrapie fonctionnant dans la gamme de 10 kV 1 MV (IEC 60601-2-8:2010) Medizinische elektrische Gerte - Teil 2-8: BesondereFestlegungen fr die Sicherheit einschlielich derwesentlichen Leistungsmerkmale von Therapie-Rntgenei

9、nrichtungen im Bereich von 10 kV bis 1 MV (IEC 60601-2-8:2010) 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 standar

10、d 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

11、any other language made by translationunder 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

12、, 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

13、and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches 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

14、any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-8:2015 E EN 60601-2-8:2015+A1January 2016EN 60601-2-8:2015 (E) 2 Foreword The text of document 62C/499/FDIS, future edition 2 of IEC 60601-2-8, prepared by SC 62C, “Equipment for radiotherapy, nuclear medicine and radiation dosime

15、try“, of IEC TC 62, “Electrical equipment in medical practice“, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-8:2015. The following dates are fixed: latest date by which the EN has to be implemented at national level by publication of an identical national

16、standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-8:1997. Attention is drawn to the possibility that some of the elements of this document may be the subject of pat

17、ent rights. CEN and CENELEC 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 th

18、e 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 60601-2-8:2010 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, th

19、e following note has to be added for the standard indicated: IEC 60601-2-17 NOTE Harmonized as EN 60601-2-17. _ BS EN 60601-2-8:2015 2 BS EN 60601-2-8:2015+A1:2016EN 60601-2-8:2015+A1:2016 (E)EN 60601-2-8:2015/A1:2016 2 European foreword The text of document 62C/593/CDV, future IEC 60601-2-8:2010/A1

20、, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-8:2015/A1:2016. The following dates are fixed: latest date by whic

21、h the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-08-03 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-11-03 Attention is drawn to the possibility that some o

22、f 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, an

23、d supports essential requirements of EU Directive(s). For the relationship with EU Directive(s), see informative Annex ZZ, included in EN 60601-2-8:2015. Endorsement notice The text of the International Standard IEC 60601-2-8:2010/A1:2015 was approved by CENELEC as a European Standard without any mo

24、dification. In the Bibliography of EN 60601-2-8:2015, replace the existing reference to IEC 60601-2-17 by the following: IEC 60601-2-17:2013 NOTE Harmonized as EN 60601-2-17:2015 (not modified). EN 60601-2-8:2015 (E) 2 Foreword The text of document 62C/499/FDIS, future edition 2 of IEC 60601-2-8, pr

25、epared by SC 62C, “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“, of IEC TC 62, “Electrical equipment in medical practice“, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-8:2015. The following dates are fixed: latest date by which the

26、 EN 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 EN have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-8:1997. Attention is drawn to

27、the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC 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 Fr

28、ee 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 60601-2-8:2010 was approved by CENELEC as a Europ

29、ean Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: IEC 60601-2-17 NOTE Harmonized as EN 60601-2-17. _ BS EN 60601-2-8:2015 3 BS EN 60601-2-8:2015+A1:2016EN 60601-2-8:2015+A1:2016 (E)EN 60601-2-8:2015/A1:201

30、6 2 European foreword The text of document 62C/593/CDV, future IEC 60601-2-8:2010/A1, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENE

31、LEC as EN 60601-2-8:2015/A1:2016. 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) 2016-08-03 latest date by which the national standards conflicting with the document hav

32、e to be withdrawn (dow) 2018-11-03 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 giv

33、en 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, included in EN 60601-2-8:2015. Endorsement notice The text of the International Standard IEC

34、60601-2-8:2010/A1:2015 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-8:2015, replace the existing reference to IEC 60601-2-17 by the following: IEC 60601-2-17:2013 NOTE Harmonized as EN 60601-2-17:2015 (not modified). Foreword to amendment

35、 A1EN 60601-2-8:2015 (E) 3 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,

36、 only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information

37、 on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies with the following exceptions: Publication Year Title EN/HD Year Addition: IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC

38、60601-2-1 2009 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV - - IEC 61217 - Radiotherapy equipment - Coordinates, movements and scales EN 61217 - ISO/IEC Guide 98-3 2008 Uncertain

39、ty of measurement - Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) - - BS EN 60601-2-8:2015EN 60601-2-8:2015 (E) 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the Eur

40、opean Commission and the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given 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 specif

41、ied essential requirements of the Directive concerned. NOTE Presumption of conformity with Essential Requirements 13.1 to 13.6 should depend on the manufacturer confirming the accuracy of the accompanying documents in all relevant languages. WARNING: Other requirements and other EU Directives can be

42、 applied to the products falling within the scope of this standard. BS EN 60601-2-8:2015 4 BS EN 60601-2-8:2015+A1:2016EN 60601-2-8:2015+A1:2016 (E)EN 60601-2-8:2015 (E) 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The follo

43、wing 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 1 When an I

44、nternational Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies with the foll

45、owing exceptions: Publication Year Title EN/HD Year Addition: IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 60601-2-1 2009 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in

46、the range 1 MeV to 50 MeV - - IEC 61217 - Radiotherapy equipment - Coordinates, movements and scales EN 61217 - ISO/IEC Guide 98-3 2008 Uncertainty of measurement - Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) - - BS EN 60601-2-8:2015EN 60601-2-8:2015 (E) 4 Annex ZZ (info

47、rmative) 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 in Annex I of

48、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. NOTE Presumption of conformity with Essential Requirements 13.1 to 13.6 should depend on the manufac

49、turer confirming the accuracy of the accompanying documents in all relevant languages. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-8:2015 5 BS EN 60601-2-8:2015+A1:2016EN 60601-2-8:2015+A1:2016 (E) 2 60601-2-8 IEC:2010 CONTENTS FOREWORD 3 INTRODUCTION 5 201.1 Scope, object and related standards 6 201.2 Normative references . 7 201.3 Terms and definitions . 8 201.4 General requirements . 8 201.5 G