1、 IEC 60601-2-40 Edition 2.0 2016-08 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment Appareils lectromdicaux Partie 2-40: Exigences particulires
2、 pour la scurit de base et les performances essentielles des lectromyographes et des appareils potentiel voqu IEC 60601-2-40:2016-08(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2016 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may
3、 be reproduced or utilized in any form or by any means, electronic 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 ab
4、out obtaining additional rights to this publication, please contact 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
5、 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 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 publicat
6、ion, utilisez les coordonnes ci-aprs ou contactez le Comit national de lIEC de votre pays de rsidence. IEC Central Office Tel.: +41 22 919 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
7、) is the leading global organization that prepares and publishes International Standards 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 editi
8、on, a corrigenda or an amendment might have been published. IEC Catalogue - webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents. Available for PC, M
9、ac OS, Android Tablets and iPad. IEC publications search - www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Just Published
10、 - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available online and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing
11、20 000 terms and definitions in English and French, with equivalent terms in 15 additional languages. Also known as the International Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/glossary 65 000 electrotechnical terminology entries in English and French extracted from the Term
12、s and Definitions clause of IEC publications issued since 2002. Some entries have been collected from earlier publications 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 con
13、tact the Customer Service Centre: csciec.ch. A propos de lIEC La Commission Electrotechnique Internationale (IEC) est la 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 public
14、ations IEC Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue IEC - webstore.iec.ch/catalogue Application autonome pour consulter tous les renseignements bibliograph
15、iques sur les Normes internationales, Spcifications techniques, Rapports techniques et autres documents de lIEC. Disponible 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 diffren
16、ts critres (numro de rfrence, texte, comit dtudes,). Elle donne aussi des informations sur les projets et les publications remplaces ou retires. IEC Just Published - webstore.iec.ch/justpublished Restez inform sur les nouvelles publications IEC. Just Published dtaille les nouvelles publications paru
17、es. Disponible en ligne et aussi une fois par mois par email. Electropedia - www.electropedia.org Le premier dictionnaire en ligne de termes lectroniques et lectriques. Il contient 20 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans 15 langues additionnelles. E
18、galement appel Vocabulaire Electrotechnique International (IEV) en ligne. Glossaire IEC - std.iec.ch/glossary 65 000 entres terminologiques lectrotechniques, en anglais et en franais, extraites des articles Termes et Dfinitions des publications IEC parues depuis 2002. Plus certaines entres antrieure
19、s extraites des publications des CE 37, 77, 86 et CISPR de lIEC. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-2-40 Edition 2.0 2016-08 INTERNATIONAL STANDARD NORME INTERNATIO
20、NALE Medical electrical equipment Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment Appareils lectromdicaux Partie 2-40: Exigences particulires pour la scurit de base et les performances essentielles des lectromyograph
21、es et des appareils potentiel voqu INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.20; 11.040.55; 11.040.99 ISBN 978-2-8322-3592-8 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Inte
22、rnationale 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. 2 IEC 60601-2-40:2016 IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 6 201.1 Scope, object and related stan
23、dards 7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements 10 201.5 General requirements for testing of ME EQUIPMENT 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11 201.7 ME EQUIPMENT identification, marking and documents . 11 201.8 Protection against e
24、lectrical 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 ins
25、truments and protection against hazardous outputs . 14 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 16 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 16 201.15 Construction of ME EQUIPMENT . 17 201.16 ME SYSTEMS 17 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT an
26、d ME SYSTEMS 17 202 * ELECTROMAGNETIC DISTURBANCES Requirements and tests . 17 Annexes . 22 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 22 Annex AA (informative) Particular guidance and rationale . 23 Bibliography . 29 Index of defined terms used
27、 in this particular standard 30 Figure AA.1 Suggested test layout for EMISSION and IMMUNITY testing 26 Figure AA.2 Example of test setup for protection against the effects of HF SURGICAL ME EQUIPMENT . 27 Figure AA.3 Example of test setup for protection against the effects of HF SURGICAL ME EQUIPMEN
28、T . 28 Table 202.101 Pass/fail criteria for Table 4 of IEC 60601-1-2:2014 . 19 Table 202.102 Pass/fail criteria for Table 7 of IEC 60601-1-2:2014 . 20 Table 202.103 Pass/fail criteria for Table 8 of IEC 60601-1-2:2014 . 20 Table 201.C.101 Marking on the outside of ELECTROMYOGRAPHS and EVOKED RESPONS
29、E EQUIPMENT or its parts . 22 IEC 60601-2-40:2016 IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment FOREWORD 1) The International Elec
30、trotechnical 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 electronic fields.
31、 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; any IEC Na
32、tional 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 Standardization
33、 (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 representati
34、on 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, IEC cannot
35、 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 publications.
36、 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 areas, acces
37、s 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 indiv
38、idual 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 reliance upon,
39、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
40、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 60601-2-40 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in med
41、ical practice. This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) no special test phantom used for EM
42、C testing; b) test method for continuous masking sound pressure level; c) test method for visual stimulators; 4 IEC 60601-2-40:2016 IEC 2016 d) allows use of equipment not intended for continuous operation; e) clarification that audible and visible indicators are not to be considered ALARM SYSTEMS a
43、s per IEC 60601-1-8. The text of this standard is based on the following documents: FDIS Report on voting 62D/1366/FDIS 62D/1394/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted i
44、n 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 appearing outside of tables, such as notes, examples and references: in smaller type. Normative tex
45、t of tables is also in a smaller type. 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 document, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive o
46、f 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 document are preceded by the term “Clause” followed by the clause number. References
47、 to subclauses within this particular standard are by number only. In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC Dir
48、ectives, Part 2. For the purposes of this document, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this document; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this
49、document; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title, or at the beginning of a paragraph or table title, indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the I
