1、BSI Standards PublicationMedical electrical equipmentPart 2-25: Particular requirements for the basic safety and essential performance of electrocardiographsBS EN 60601-2-25:2015National forewordThis British Standard is the UK implementation of EN 60601-2-25:2015. It is identical to IEC 60601-2-25:2
2、011. It supersedes BS EN 60601-2-25:1996 and BS EN 60601-2-51:2003, which will be withdrawn on 15 September 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice,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 org
3、anizations represented 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 201
4、5ISBN 978 0 580 59597 4ICS 11.040.55; 11.040.99Compliance 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 November 2015.Amendments/corrigenda issued since publicationDate
5、Text affectedBRITISH STANDARDBS EN 60601-2-25:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-25 October 2015 ICS 11.040.55; 11.040.99 Supersedes EN 60601-2-25:1995, EN 60601-2-51:2003 English Version Medical electrical equipment - Part 2-25: Particular requirements for the basic sa
6、fety and essential performance of electrocardiographs (IEC 60601-2-25:2011) Appareils lectromdicaux - Partie 2-25: Exigences particulires pour la scurit de base et les performances essentielles des lectrocardiographes (IEC 60601-2-25:2011) Medizinische elektrische Gerte - Teil 2-25: Besondere Festle
7、gungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Elektrokardiographen (IEC 60601-2-25:2011) This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givi
8、ng 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 three
9、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 electro
10、technical 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, Roman
11、ia, 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 Brussels
12、 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-25:2015 E BS EN 60601-2-25:2015EN 60601-2-25:2015 2 European foreword The text of document 62D/944/FDIS, future edition 2 of IEC 60601-2-25, prepared by SC 62D “Electrome
13、dical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-25:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identi
14、cal national standard or by endorsement (dop) 2016-06-15 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-09-15 This document supersedes EN 60601-2-25:1995 and EN 60601-2-51:2003. Attention is drawn to the possibility that some of the elements
15、 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, and supports ess
16、ential requirements of EU Directive(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 60601-2-25:2011 was approved by CENELEC as a European Standard without any mod
17、ification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-2-27 NOTE Harmonized as EN 60601-2-27. IEC 60601-2-47 NOTE Harmonized as EN 60601-2-47. BS EN 60601-2-25:2015EN 60601-2-25:2015 3 Annex ZA (normative) Normative reference
18、s 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, only the edition cited applies. For undated references, the latest
19、 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 on the latest versions of the European Standards listed in this an
20、nex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replacement in Annex ZA of EN 60601-1:2006: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performan
21、ce - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 - - + corrigendum Mar. 2010 Addition to Annex ZA of EN 60601-1:2006: IEC 60601-2-2 2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance o
22、f high frequency surgical equipment and high frequency surgical accessories EN 60601-2-2 2009 - - + A11 2011 BS EN 60601-2-25:2015EN 60601-2-25:2015 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC
23、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 with
24、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 60601-2-25:2015 2 60601-2-25 IEC:2011 CONTENTS FOREWORD . 5 INTRODUCTION . 7 201.1 Scope, object and re
25、lated standards 8 201.2 Normative references 10 201.3 Terms and definitions 10 201.4 General requirements 12 201.5 General requirements for testing of ME EQUIPMENT . 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 13 201.7 ME EQUIPMENT identification, marking and documents 13 201.8 Protection
26、 against electrical HAZARDS from ME EQUIPMENT 16 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 21 201.10 Protection against unwanted and excessive radiation HAZARDS 21 201.11 Protection against excessive temperatures and other HAZARDS 21 201.12 Accuracy of controls and i
27、nstruments and protection against hazardous outputs 22 201.13 HAZARDOUS SITUATIONS and fault conditions . 37 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 37 201.15 Construction of ME EQUIPMENT . 37 201.16 ME SYSTEMS. 37 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 3
28、7 202 Electromagnetic compatibility Requirements and tests . 38 Annexes . 43 Annex AA (informative) Particular guidance and rationale 44 Annex BB (informative) ELECTRODES, their positions, identifications and colour codes . 51 Annex CC (informative) LEADS, their identification and colour codes (othe
29、r than those specified in 201.12.4.102) . 53 Annex DD (informative) Polarity of PATIENT LEADS (other than those specified in 201.12.4.102) . 54 Annex EE (informative) Additional marking of ELECTRODES . 55 Annex FF (informative) Definitions and rules for the measurement of ELECTROCARDIOGRAMS . 56 Ann
30、ex GG (informative) Calibration and test data sets . 61 Annex HH (informative) CTS test atlas . 63 Bibliography 94 Index of defined terms used in this particular standard 95 Figure 201.101 ELECTRODE position according to Frank . 14 Figure 201.102 Test of protection against the effects of defibrillat
31、ion (differential mode) (see 201.8.5.5.1) 19 Figure 201.103 Test of protection against the effects of defibrillation (common mode) (see 201.8.5.5.1) 20 Figure 201.104 Application of the test voltage between LEAD WIRES to test the energy delivered by the defibrillator 21 BS EN 60601-2-25:201560601-2-
32、25 IEC:2011 3 Figure 201.105 Test circuit for COMMON MODE REJECTION and NOISE level . 28 Figure 201.106 General test circuit 30 Figure 201.107 Triangular waveforms for test E of Table 201.107 32 Figure 201.108 Input impulse signal and ELECTROCARDIOGRAPH response 32 Figure 201.109 Circuit for test of
33、 linearity. 34 Figure 201.110 Result of linearity test 34 Figure 201.111 Pacemaker overload test circuit . 36 Figure 202.101 Set-up for radiated and conducted emission test . 39 Figure 202.102 Set-up for radiated immunity test . 40 Figure 202.103 Test circuit for HF surgery protection measurement .
34、42 Figure 202.104 Test setup for HF surgery protection measurement 43 Figure BB.1a LEADS and colours for fetal ECG (see Table BB.2) . 52 Figure BB.1b Positions of the ELECTRODES on the fetus for fetal ECG (see Table BB.2) . 52 Figure BB.2 LEAD positions and colours for fetal scalp ECG (see Table BB.
35、2) . 52 Figure FF.1 Normal ELECTROCARDIOGRAM . 56 Figure FF.2 Determination of global intervals (example) 57 Figure FF.3 Waveform durations, isoelectric segments 58 Figure FF.4 QRS complex with small R-wave(s) (see Figure FF.5, FF.6) . 59 Figure FF.5 Detail of small accepted R-wave . 60 Figure FF.6
36、Detail of small rejected R-wave . 60 Figure HH.1 Nomenclature of calibration ECGS . 66 Figure HH.2 Nomenclature of analytical ECGs 69 Table 201.101 ESSENTIAL PERFORMANCE requirements . 12 Table 201.102 ELECTRODES, their position, identification and colour code . 14 Table 201.103 Protection against t
37、he effect of defibrillation (test conditions) 18 Table 201.104 Acceptable mean differences and standard deviations for global intervals and Q-, R-, S-durations on calibration and analytical ECGS . 23 Table 201.105 Acceptable mean differences and standard deviations for global durations and intervals
38、 for biological ECGs 23 Table 201.106 LEADS and their identification (nomenclature and definition) 25 Table 201.107 Frequency response . 31 Table 201.108 PATIENT ELECTRODE connection for pacemaker pulse display test 37 Table AA.1 ELECTRODE positions and electrical strength requirements . 46 Table BB
39、.1 ELECTRODES, their positions, identifications and colour codes (other than described in 201.7.4.101, Table 201.106) . 51 Table BB.2 Other ELECTRODE-positions, identifications and colour codes not covered by this particular standard . 51 Table DD.1 ELECTRODE polarities . 54 Table EE.1 Recommended i
40、dentification and colour code for a 14-wire PATIENT CABLE . 55 Table GG.1 CALIBRATION and analytical ECGS . 61 Table GG.2 Data set for testing of measurement and wave recognition accuracy of biological data 100 selected ECGS of the CSE-study with their numbering in the CSE database, to be used in 20
41、1.12.1.101.3.2 . 62 Table HH.1 Naming of signals (calibration ECGS) . 67 BS EN 60601-2-25:2015 4 60601-2-25 IEC:2011 Table HH.2 Naming of signals (analytical ECGs) . 68 BS EN 60601-2-25:201560601-2-25 IEC:2011 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-25: Part
42、icular requirements for the basic safety and essential performance of electrocardiographs 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 i
43、s to promote international co-operation on all questions concerning standardization 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) an
44、d 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-governmental organizations liaising with the
45、 IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (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
46、as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation 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 se
47、nse. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC 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 un
48、dertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. 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 a
49、ttestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, 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 including individual exp
