1、 IEC 60601-2-26 Edition 3.0 2012-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs Appareils lectromdicaux Partie 2-26: Exigences particulires pour la scurit de base
2、et les performances essentielles des lectroencphalographes IEC 60601-2-26:2012 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 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 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) is the leading global organization that prepares an
7、d 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 edition, a corrigenda or an amendment might have been publ
8、ished. Useful links: IEC publications search - www.iec.ch/searchpub The advanced search enables you 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 It also gives information on projects, replaced and withdrawn publications.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 - webst
9、ore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available on-line and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more th
10、an 30 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary (IEV) on-line. Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assi
11、stance, please contact the Customer Service Centre: csciec.ch. 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 technologies apparentes.
12、 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. Liens utiles: Recherche de publications CEI - www.iec.ch/searchpub La recherche avance
13、vous permet de trouver des publications CEI en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Elle donne aussi des informations sur les projets et les publications remplaces ou retires. Just Published CEI - webstore.iec.ch/justpublished Restez inform sur les nouvelles publicat
14、ions de la CEI. Just Published dtaille les nouvelles publications parues. Disponible en ligne et aussi une fois par mois par email. Electropedia - www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 30 000 termes et dfinitions en a
15、nglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International (VEI) en ligne. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions cont
16、actez-nous: csciec.ch. IEC 60601-2-26 Edition 3.0 2012-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs Appareils lectromdicaux Partie 2-26: Exigences particulires p
17、our la scurit de base et les performances essentielles des lectroencphalographes INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE U ICS 11.040.55; 11.040.99 PRICE CODE CODE PRIX ISBN 978-2-83220-117-6 Registered trademark of the International Electrotechnical Comm
18、ission Marque 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. 2 60601-2-26 IEC:2012 CONTENTS FOREWORD . 3 INTR
19、ODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 8 201.3 Terms and definitions 8 201.4 General requirements 9 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 10 201.7 ME EQUIPMENT identification, mar
20、king and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 17 201.10 Protection against unwanted and excessive radiation HAZARDS 17 201.11 Protection against excessive temperatures and other HAZARD
21、S 17 201.12 Accuracy of controls and instruments and protection against hazardous outputs 18 201.13 HAZARDOUS SITUATIONS and fault conditions . 23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23 201.15 Construction of ME EQUIPMENT . 23 201.16 ME SYSTEMS 23 201.17 ELECTROMAGNETIC COMPATIBI
22、LITY of ME EQUIPMENT and ME SYSTEMS . 23 202 ELECTROMAGNETIC COMPATIBILITY Requirements and tests 23 Annexes . 26 Annex AA (informative) Particular guidance and rationale 27 Index of defined terms used in this particular standard 29 Figure 201.101 Test of protection against the effects of defibrilla
23、tion (common mode) . 14 Figure 201.102 Test of protection against the effects of defibrillation (differential mode) . 15 Figure 201.103 Application of the test voltage between LEAD WIRES to test the energy delivered by the defibrillator 16 Figure 201.104 General test circuit 20 Figure 201.105 Test c
24、ircuit for COMMON MODE REJECTION 22 Figure 202.101 Test layout for radiated and conducted EMISSION test and radiated immunity test 24 Figure 202.102 Set-up for radiated immunity test according to 202.6.2.3.2 25 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 10 60601-2-26 IEC:2012 3 INT
25、ERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
26、 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. To this end and in addition to other activities, IEC publishes International Standards,
27、 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 National Committee interested in the subject dealt with may participate in this preparator
28、y 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 (ISO) in accordance with conditions determined by agreement between the two organizatio
29、ns. 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 representation from all interested IEC National Committees. 3) IEC Publications have the form of rec
30、ommendations 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 be held responsible for the way in which they are used or for any misinterpretation by
31、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. Any divergence between any IEC Publication and the corresponding national or regional p
32、ublication 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, access to IEC marks of conformity. IEC is not responsible for any services carried out by ind
33、ependent 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 experts and members of its technical committees and IEC National Committees for an
34、y 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, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normati
35、ve 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 be the subject of patent rights. IEC shall not be held responsi
36、ble for identifying any or all such patent rights. International standard IEC 60601-2-26 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition of IEC 606
37、01-2-26 published in 2002. This edition constitutes a technical revision to the new structure of the third edition (2005) of IEC 60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/990/FDIS 62D/1012/RVD Full information on the voting for the a
38、pproval of this particular standard can be found in the report on voting indicated in the above table. 4 60601-2-26 IEC:2012 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
39、type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text 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 CAP
40、ITALS. In referring to the structure of this standard, the term “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 a
41、nd 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 number. References to subclauses within this collateral standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a
42、statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandato
43、ry for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first characte
44、r 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 IEC website. The committee h
45、as decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or
46、 amended. 60601-2-26 IEC:2012 5 INTRODUCTION This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General requirements for basic safety and essential p
47、erformance), hereinafter referred to as the general standard. 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 technical changes. The requirements of this particular standard take priori
48、ty over those of the general standard. A “General guidance and rationale” for the more important requirements of this particular standard is included in Annex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but
49、 will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, Annex AA does not form part of the requirements of this standard. 6 60601-2-26 IEC:2012 MEDICAL ELECTRICAL EQUIPMENT Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs 201.1 Scope, object and related standards
