1、 IEC 62353 Edition 2.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Recurrent test and test after repair of medical electrical equipment Appareils lectromdicaux Essai rcurrent et essai aprs rparation dun appareil lectromdical IEC 62353:2014-09(en-fr) colour inside
2、 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 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, electronic or mechanical, including photocopying and microfilm, without permission
3、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 contact the address below or your local IEC member National Committee for furth
4、er 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 compris la photocopie et les microfilms, sans laccord crit de lIEC ou du Comit
5、national de lIEC du pays du demandeur. Si vous avez des questions sur le copyright de lIEC ou si vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de lIEC de votre pays de rsidence. IEC Central Office Tel.: +41 22 919
6、02 11 3, rue de Varemb Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technol
7、ogies. 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. IEC Catalogue - webstore.iec.ch/catalogue The stand-alone application for consu
8、lting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents. Available for PC, Mac OS, Android Tablets and iPad. IEC publications search - www.iec.ch/searchpub The advanced search enables to find IEC publications by a v
9、ariety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Availab
10、le online and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French, with equivalent terms in 14 additional languages. Also known as the Internati
11、onal Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/glossary More than 55 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002. Some entries have been collected from earlier publicati
12、ons of IEC TC 37, 77, 86 and CISPR. IEC Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. A propos de lIEC La Commission Electrotechnique Internationale (IEC) est l
13、a premire organisation mondiale qui labore et publie des Normes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparentes. A propos des publications IEC Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possdez lditi
14、on la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue IEC - webstore.iec.ch/catalogue Application autonome pour consulter tous les renseignements bibliographiques sur les Normes internationales, Spcifications techniques, Rapports techniques et autres documents de lIEC. Dispon
15、ible pour PC, Mac OS, tablettes Android et iPad. Recherche de publications IEC - www.iec.ch/searchpub La recherche avance permet de trouver des publications IEC en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Elle donne aussi des informations sur les projets et les publicati
16、ons remplaces ou retires. IEC Just Published - webstore.iec.ch/justpublished Restez inform sur les nouvelles publications IEC. Just Published dtaille les nouvelles publications parues. Disponible en ligne et aussi une fois par mois par email. Electropedia - www.electropedia.org Le premier dictionnai
17、re en ligne de termes lectroniques et lectriques. Il contient plus de 30 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans 14 langues additionnelles. Egalement appel Vocabulaire Electrotechnique International (IEV) en ligne. Glossaire IEC - std.iec.ch/glossary P
18、lus de 55 000 entres terminologiques lectrotechniques, en anglais et en franais, extraites des articles Termes et Dfinitions des publications IEC parues depuis 2002. Plus certaines entres antrieures extraites des publications des CE 37, 77, 86 et CISPR de lIEC. Service Clients - webstore.iec.ch/csc
19、Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 62353 Edition 2.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Recurrent test and test after repair of medical electrical equipment Appar
20、eils lectromdicaux Essai rcurrent et essai aprs rparation dun appareil lectromdical INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040 PRICE CODE CODE PRIX ISBN 978-2-8322-1847-1 Registered trademark of the International Electrotechnical Commission Mar
21、que dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colour inside 2 IEC 62353:2014 IEC 2014 CONTENTS FOREWORD
22、 5 1 Scope 7 2 Normative references 8 3 Terms and definitions 8 4 Requirements 16 4.1 * General requirements . 16 4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR 17 4.3 * RECURRENT TEST . 18 5 * Tests . 18 5.1 General . 18 5.2 Visual INSPECTION . 18 5.3 Measurements 1
23、9 5.3.1 General . 19 5.3.2 Measuring of PROTECTIVE EARTH RESISTANCE 19 * Measurement of insulation resistance (not mandatory) 21 5.3.3Leakage currents . 24 5.3.4 5.4 Functional test 31 6 Results of test and evaluation 31 6.1 Reporting of results. 31 6.2 Evaluation . 32 Annex A (informative) General
24、guidance and rationale . 33 A.1 Intended audience 33 A.2 Differences between IEC 60601-1 and IEC 62353 . 34 A.3 Rationale 35 Annex B (informative) Sequence of testing 42 Annex C (normative) Requirements for the measurement equipment and for measurement circuits for PROTECTIVE EARTH RESISTANCE and le
25、akage currents . 44 C.1 Requirements for the measurement equipment . 44 C.2 Measurement equipment for measurement of PROTECTIVE EARTH RESISTANCE 44 C.3 Measurement equipment for measurements of EQUIPMENT LEAKAGE CURRENT 45 C.4 Measurement equipment for measurements of APPLIED PART LEAKAGE CURRENT .
26、45 Annex D (informative) PATIENT ENVIRONMENT 47 Annex E (normative) Allowable values for leakage currents from IEC 60601-1 . 48 Annex F (informative) Testing intervals 51 Annex G (informative) Example of test documentation . 52 Annex H (informative) Notes on testing ME SYSTEMS . 53 H.1 Overview 53 H
27、2 Guidelines for re-testing of an ME SYSTEM 53 H.3 Guidelines on ME SYSTEMS from the rationale annex of IEC 60601- 1:2005 /AMD1:2012 54 H.4 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) 58 Bibliography 60 Index of defined terms 61 IEC 62353:2014 IEC 2014 3 Figure 1 Measuring circuit for
28、the measurement of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT that is disconnected from the SUPPLY MAINS 20 Figure 2 Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT or ME SYSTEMS, which for functional reasons cannot be disconnected from the SUPPLY MAINS, or in M
29、E EQUIPMENT or ME SYSTEMS permanently connected to the SUPPLY MAINS 20 Figure 3 Measuring circuit for the measurement of the insulation resistance between MAINS PART and protective earth for CLASS I ME EQUIPMENT and between MAINS PART and (non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLA
30、SS II ME EQUIPMENT . 22 Figure 4 Measuring circuit for measurement of the insulation resistance between MAINS PART and APPLIED PARTS which make a patient connection for CLASS I or CLASS II ME EQUIPMENT . 23 Figure 5 Measuring circuit for measurement of the insulation resistance between F- TYPE APPLI
31、ED PARTS which make a patient connection and protective earth for CLASS I ME EQUIPMENT and between F-TYPE APPLIED PARTS which make a patient connection and (non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II ME EQUIPMENT 23 Figure 6 Measuring circuit for the measurement of ME EQUIPMEN
32、T leakage current alternative method 26 Figure 7 Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT direct method 27 Figure 8 Measuring circuit for the measurement EQUIPMENT LEAKAGE CURRENT differential method 28 Figure 9 Measuring circuit for the measurement of APPLIED PART LEAKAGE
33、CURRENT “F- TYPE APPLIED PART” alternative method . 29 Figure 10 Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT MAINS VOLTAGE on F-TYPE APPLIED PART direct method 30 Figure 11 Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT for equipment with an INTERNAL
34、ELECTRICAL POWER SOURCE direct method 30 Figure A.1 CLASS I ME EQUIPMENT with no earthed ACCESSIBLE CONDUCTIVE PARTS of the enclosure 37 Figure A.2 Plugged-in CLASS I ME EQUIPMENT 37 Figure A.3 Plugged-in CLASS II ME EQUIPMENT . 38 Figure A.4 Plugged-in CLASS I ME EQUIPMENT with mains on the APPLIED
35、 PART . 38 Figure A.5 Plugged-in CLASS II ME EQUIPMENT with mains on the APPLIED PART 39 Figure B.1 Sequence of testing 42 Figure B.2 Measurement of LEAKAGE CURRENTS (non-PERMANENTLY INSTALLED CLASS I ME EQUIPMENT) 43 Figure C.1 Example of a measuring device and its frequency characteristics . 46 Fi
36、gure D.1 Example of PATIENT ENVIRONMENT . 47 Figure G.1 Example of test documentation . 52 Figure H.1 Example of the construction of a MULTIPLE SOCKET-OUTLET (MSO) (accessible only with the use of a tool) 58 Figure H 2 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) 59 Table 1 Legends of sy
37、mbols 21 Table 2 Insulation resistance values 24 Table 3 Allowable values for leakage currents . 31 Table A.1 Addressees and their possible interest in this standard 33 Table A.2 Reasons for choosing different measuring methods . 40 4 IEC 62353:2014 IEC 2014 Table E.1 Allowable values for continuous
38、 leakage currents from IEC 60601-1:1988 . 48 Table E.2 Allowable values for TOUCH CURRENTS, EARTH LEAKAGE CURRENTS, PATIENT LEAKAGE CURRENTS and patient auxiliary currents under NORMAL CONDITION and SINGLE FAULT CONDITION from IEC 60601-1:2005 . 49 Table E.3 Allowable values for PATIENT LEAKAGE CURR
39、ENTS under the special test conditions identified in 8.7.4.7 of IEC 60601-1:2005 . 50 Table H.1 Some examples of ME SYSTEMS for illustration. 56 IEC 62353:2014 IEC 2014 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRIC
40、AL EQUIPMENT 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 standardi
41、zation 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) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation i
42、s 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 IEC also participate in this preparation. IEC collaborates closely with the
43、 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 as possible, an international consensus of opinion on the relevant subjects
44、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 sense. While all reasonable efforts are made to ensure that the technical cont
45、ent 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 undertake to apply IEC Publications transparently to the maximum extent possib
46、le 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 attestation of conformity. Independent certification bodies provide conformit
47、y 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
48、 employees, 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
49、 of the publication, 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 possibility that some of the elements of this IEC Publication may b
