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
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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
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