BS EN 60601-2-47-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems《医疗电气设备 动态心电图系统基.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systemsBS EN 60601-2-47:2015National forewordThis British Standard is the UK implementation of EN 60601-2-47:2015. It isidentical

2、to IEC 60601-2-47:2012. It supersedes BS EN 60601-2-47:2001,which will be withdrawn on 14 April 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of organizations r

3、epresented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0

4、580 59726 8ICS 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDA

5、RDBS EN 60601-2-47:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-47 May 2015 ICS 11.040.55 Supersedes EN 60601-2-47:2001 English Version Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiograp

6、hic systems (IEC 60601-2-47:2012) Appareils lectromdicaux - Partie 2-47: Exigences particulires pour la scurit de base et les performances essentielles des systmes dlectrocardiographie ambulatoires (IEC 60601-2-47:2012) Medizinische elektrische Gerte - Teil 2-47: Besondere Festlegungen fr die Sicher

7、heit einschlielich der wesentlichen Leistungsmerkmale von ambulanten elektrokardiographischen Systemen (IEC 60601-2-47:2012) 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

8、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 th

9、ree 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 ele

10、ctrotechnical 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, R

11、omania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brus

12、sels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-47:2015 E BS EN 60601-2-47:2015EN 60601-2-47:2015 2 Foreword The text of document 62D/963/FDIS, future edition 2 of IEC 60601-2-47, prepared by SC 62D “Electromedical

13、 equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-47:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical n

14、ational 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 60601-2-47:2001. Attention is drawn to the possibility that some of the elements of this document may be the

15、 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 Di

16、rective(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-47:2012 was approved by CENELEC as a European Standard without any modification. In the official v

17、ersion, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-2-25 NOTE Harmonized as EN 60601-2-25. IEC 60601-2-27 NOTE Harmonized as EN 60601-2-27. BS EN 60601-2-47:2015EN 60601-2-47:2015 3 Annex ZA (normative) Normative references to international publicati

18、ons 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 d

19、ocument (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 on the latest versions of the European Standards listed in this annex is available here: www.c

20、enelec.eu. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year In Annex ZA of EN 60601-1:2006 replace IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral

21、 standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 - - + corrigendum Mar. 2010 BS EN 60601-2-47:2015EN 60601-2-47:2015 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENEL

22、EC 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 EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity wi

23、th the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-47:2015 2 60601-2-47 IEC:2012 CONTENTS FOREWORD . 4 INTRODUCTION . 6 201.1 Scope, object and

24、 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 of ME EQUIPMENT . 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identification, marking and documents 12 201.8 Protectio

25、n 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 14 201.12 Accuracy of controls and

26、instruments and protection against hazardous outputs . 14 201.13 HAZARDOUS SITUATIONS and fault conditions . 38 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 38 201.15 Construction of ME EQUIPMENT . 38 201.16 ME SYSTEMS. 39 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEM

27、S 39 202 Electromagnetic compatibility Requirements and tests . 40 Annexes . 42 Annex AA (informative) Particular guidance and rationale 43 Bibliography 64 Index of defined terms used in this particular standard 65 Figure 201.101 General test circuit for 201.12.4.4 29 Figure 201.102 Test signal for

28、input dynamic range test according to 201.12.4.4.101 30 Figure 201.103 Test circuit for common mode rejection according to 201.12.4.4.103 . 33 Figure 201.104 Test circuit for pacemaker pulse tolerance according to 201.12.4.4.109 37 Figure 202.101 Test set-up for conductive emission test according to

29、 202.6.1.1.2 and radiated emission and radiated immunity test according to 202.6.1.1.2 and 202.6.2.3.2 41 Table 201.101 Distributed additional ESSENTIAL PERFORMANCE requirements 11 Table 201.102 LEAD WIRE colour codes 13 Table 201.103 Requirements for all arrhythmia algorithms . 17 Table 201.104 Req

30、uirements for algorithms with optional capabilities 18 Table 201.105 Beat label classifications 22 Table 201.106 Example of noise floor calculation results . 24 Table 201.107 Example of HRV test results 25 Table 201.108 Run sensitivity summary matrix 25 Table 201.109 Run positive predictivity summar

31、y matrix 26 BS EN 60601-2-47:201560601-2-47 IEC:2012 3 Table AA.1 Records to be included in a complete test 44 Table AA.2 Example of a line-format, beat-by-beat performance report 48 Table AA.3 Condensed beat-by-beat summary matrix containing 11 elements . 49 Table AA.4 Summary table (matrix format)

32、 of beat-by-beat comparison . 49 Table AA.5 Example of a line-format SHUTDOWN report . 50 Table AA.6 Example of a line-format report 51 Table AA.7 Example of VF performance report . 51 Table AA.8 Example of false VF performance report . 51 Table AA.9 Example of a line-format couplet and run performa

33、nce report 52 Table AA.10 Example of device measurements of synthetic test patterns . 53 Table AA.11 Example of predicted ideal values for synthetic test patterns . 54 Table AA.12 Example of choice of test patterns . 54 Table AA.13 Example of RMS interval differences . 57 Table AA.14 Example of summ

34、ary of frequency components . 58 BS EN 60601-2-47:2015 4 60601-2-47 IEC:2012 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems FOREWORD 1) The Internati

35、onal 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 electroni

36、c 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; a

37、ny 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 Standar

38、dization (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 repr

39、esentation 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, IE

40、C cannot be held responsible for the way 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 publi

41、cations. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some area

42、s, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents includi

43、ng individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or relianc

44、e upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elem

45、ents 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. International standard IEC 60601-2-47 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipmen

46、t in medical practice. This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1. The text of this particular standard is based on the following documents: FDI

47、S Report on voting 62D/963/FDIS 62D/980/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. BS EN 60601-2-47:201560601-2-47 IEC:2012 5 This publication has been drafted in accordance with the ISO/IEC Direc

48、tives, 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 ty

49、pe. 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). Referenc