IEC 60601-2-4-2010 Medical electrical equipment - Part 2-4 Particular requirements for basic safety and essential performance of cardiac defibrillators《医用电气设备.第2-4部分 心脏除颤器基本安全性和必要性能的详细要求》.pdf

《IEC 60601-2-4-2010 Medical electrical equipment - Part 2-4 Particular requirements for basic safety and essential performance of cardiac defibrillators《医用电气设备.第2-4部分 心脏除颤器基本安全性和必要性能的详细要求》.pdf》由会员分享，可在线阅读，更多相关《IEC 60601-2-4-2010 Medical electrical equipment - Part 2-4 Particular requirements for basic safety and essential performance of cardiac defibrillators《医用电气设备.第2-4部分 心脏除颤器基本安全性和必要性能的详细要求》.pdf（160页珍藏版）》请在麦多课文档分享上搜索。

1、 IEC 60601-2-4 Edition 3.0 2010-12 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators Appareils lectromdicaux Partie 2-4: Exigences particulires pour la scurit de base et

2、les performances essentielles des dfibrillateurs cardiaques IEC 60601-2-4:2010 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2010 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elect

3、ronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please c

4、ontact the address below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y c

5、ompris la photocopie et les microfilms, sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Co

6、mit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Stand

7、ards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Catalogue of IEC publica

8、tions: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all n

9、ew IEC publications. Just Published details twice a month all new publications released. Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and Fr

10、ench, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre

11、 FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des normes internationales pour tout ce qui a trait llectricit, llectronique et aux techn

12、ologies apparentes. A propos des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f

13、.htm Le Catalogue en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications retires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez info

14、rm sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 20

15、000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm Si vous dsirez nous donner des commentaires sur

16、cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60601-2-4 Edition 3.0 2010-12 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-4: Particular requireme

17、nts for the basic safety and essential performance of cardiac defibrillators Appareils lectromdicaux Partie 2-4: Exigences particulires pour la scurit de base et les performances essentielles des dfibrillateurs cardiaques INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNAT

18、IONALE XC ICS 11.040.10 PRICE CODE CODE PRIX ISBN 978-2-88912-254-7 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-2-4 IEC:2010 CONTENTS FORE WORD 4 201.1 Scope, object and related standards 7 201.2 Normativ

19、e 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 13 201.8 Protection against electrical HAZARDS fro

20、m ME EQUIPMENT 17 201.9 Protection against MECAHNICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 23 201.10 Protection against unwanted and excessive radiation HAZARDS . 23 201.11 Protection against excessive temperatures and other HAZARDS . 23 201.12 * Accuracy of controls and instruments and protection

21、 against hazardous outputs . 25 201.13 HAZARDOUS SITUATIONS and fault conditions 27 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27 201.15 Construction of ME EQUIPMENT . 27 201.16 ME SYSTEMS 32 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 32 201.101 * Charging tim

22、e . 32 201.102 Internal electrical power source . 35 201.103 * Endurance 36 201.104 * Synchronizer . 37 201.105 * Recovery of the MONITOR and/or ECG input after defibrillation 37 201.106 * Disturbance to the MONITOR from charging or internal discharging 41 201.107 * Requirements for RHYTHM RECOGNITI

23、ON DETECTOR . 42 201.108 D EFIBRILLATOR ELECTRODES . 43 201.109 * External pacing (U.S.) 45 202 * Electromagnetic compatibility Requirements and tests 49 Annexes 52 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS . 53 Annex AA (informative) Particula

24、r guidance and rationale 55 Annex BB (informative) Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 68 Bibliography . 73 Index of defined terms used in this particular standard . 74 Figure 201.101 Dynamic test for limitation of energy from different parts of

25、 the ME EQUIPMENT 18 Figure 201.102 Allowed current versus applied test voltage . 22 Figure 201.103 Examples of cord anchorages that require testing . 31 Figure 201.104 Test apparatus for flexible cords and their anchorages 32 60601-2-4 IEC:2010 3 Figure 201.105 Arrangement for test of recovery afte

26、r defibrillation . 39 Figure 201.106 Arrangement of monitoring electrodes on sponge . 40 Figure 201.107 Arrangement for recovery test after defibrillation 40 Figure 201.108 Arrangement for test of disturbance from charging and internal discharging 42 Figure 201.109 Test circuit for offset instabilit

27、y/internal noise determination 49 Figure 201.110 Test circuit for DEFIBRILLATOR overload test of pacing output circuitry 49 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements . 12 Table 201.102 Rhythm recognition detector categories 42 Table 201.C.101 Marking on the outside of a CARDIAC DE

28、FIBRILLATOR or its parts 53 Table 201.C.102 Marking of controls and instruments of a CARDIAC DEFIBRILLATOR 53 Table 201.C.103 ACCOMPANYING DOCUMENTS, general 53 Table 201.C.104 ACCOMPANYING DOCUMENTS, instructions for use . 54 Table 201.C.105 ACCOMPANYING DOCUMENTS, technical description . 54 Table

29、BB.1 Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 . 68 4 60601-2-4 IEC:2010 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillator

30、s 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 standardization in t

31、he 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

32、 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 IEC also participate in this preparation. IEC collaborates closely with the Internatio

33、nal 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 as possible, an international consensus of opinion on the relevant subjects since each

34、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 sense. While all reasonable efforts are made to ensure that the technical content of IEC

35、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 undertake to apply IEC Publications transparently to the maximum extent possible in their

36、 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 attestation of conformity. Independent certification bodies provide conformity assessmen

37、t 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

38、, servants or agents including 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 pub

39、lication, use of, or reliance 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 possi

40、bility that some of the elements 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 60601-2-4 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical co

41、mmittee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause number

42、ing structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and

43、technical changes. The principle technical changes are as follows: 201.8.8.3, test 4: added additional test options; 60601-2-4 IEC:2010 5 Figure 201.105: provided example of stainless steel plates. Added note for 10 Hz generator or shockable rhythm generator; Figure 201.101: Changed orientation of t

44、he lower diode at the oscilloscope connection; 202.6.1, .2, .4: “Additions“ and “Replacements“ corrected to be as originally intended; 201.101.1: Clarified preconditioning of a non-rechargeable battery; 201.3.207: Clarified definition of DUMMY COMPONENT; 201.15.4.101: In paragraph b), added reduced

45、flex requirements for sterilizable internal paddles with specified limit on sterilization cycles; 201.15.4.3.103: Added an option for devices having non-changeable pre-programmed energy-setting sequences; 201.102.3.1, 2: Changed from specified defibrillation cycles to use of pre-programmed defibrill

46、ation sequence; 202.6.2.2.1: Changed ESD discharge sequence to match IEC 60601-1-2, third edition. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/857/FDIS 62D/878/RVD Full information on the voting for the approval of this particular standard can

47、be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material a

48、ppearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. T ERMS 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 te

49、rm “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). References to clauses within this standard are preceded by the term “Clause” followed by the clause n