1、 IEC 60601-2-36 Edition 2.0 2014-04 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy Appareils lectromdicaux Partie 2-36: Exigences particul
2、ires pour la scurit de base et les performances essentielles des appareils pour lithotritie cre de faon extracorporelle IEC 60601-2-36:2014-04(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publi
3、cation may 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
4、enquiry about 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 que
5、lque 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 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 cett
6、e 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 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 Commi
7、ssion (IEC) 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 la
8、test edition, 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
9、 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 variety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Just
10、 Published - 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 c
11、ontaining more than 30 000 terms and definitions in English and French, with equivalent terms in 14 additional languages. Also known as the International Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/glossary More than 55 000 electrotechnical terminology entries in English and
12、French extracted from the Terms 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
13、further assistance, please contact 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 a
14、pparentes. A propos des publications 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
15、les renseignements bibliographiques 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 publica
16、tions IEC en utilisant diffrents 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 l
17、es nouvelles publications parues. 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 plus de 30 000 termes et dfinitions en anglais et en franais, ainsi que les termes quival
18、ents dans 14 langues additionnelles. Egalement appel Vocabulaire Electrotechnique International (IEV) en ligne. Glossaire IEC - std.iec.ch/glossary Plus de 55 000 entres terminologiques lectrotechniques, en anglais et en franais, extraites des articles Termes et Dfinitions des publications IEC parue
19、s depuis 2002. Plus certaines entres antrieures 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 60601-2-36 Edition 2.0 2
20、014-04 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy Appareils lectromdicaux Partie 2-36: Exigences particulires pour la scurit de base e
21、t les performances essentielles des appareils pour lithotritie cre de faon extracorporelle INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE S ICS 11.040.01 PRICE CODE CODE PRIX ISBN 978-2-8322-1498-5 Registered trademark of the International Electrotechnical Commi
22、ssion 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 IEC 60601-2-36:2014 IEC 2014 CONTENTS FOREWORD
23、 3 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements 10 201.5 General requirements for testing ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identificatio
24、n, marking 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 . 12 201.10 Protection against unwanted and excessive radiation HAZARDS 13 201.11 Protection against excessive temperatures and othe
25、r HAZARDS 13 201.12 Accuracy of controls and instruments and protection against hazardous outputs 13 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15 201.15 Construction of ME EQUIPMENT . 15 201.16 ME SYSTEMS . 15 201.1
26、7 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 15 202 * ELECTROMAGNETIC COMPATIBILITY Requirements and tests 15 Annexes . 15 Annex AA (informative) Particular guidance and rationale 16 Annex BB (informative) Definition of coordinates, FOCUS and TARGET LOCATION 17 Bibliography 18 In
27、dex of defined terms used in this particular standard 20 Figure BB.1 Geometrical FOCUS distribution . 17 IEC 60601-2-36:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-36: Particular requirements for the basic safety and essential performance of equipm
28、ent for extracorporeally induced lithotripsy 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 al
29、l questions concerning standardization 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 Publi
30、cation(s)”). Their preparation is 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. I
31、EC collaborates closely with the 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 o
32、pinion on the relevant subjects 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 t
33、o 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 any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparen
34、tly to the maximum extent possible 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 certif
35、ication 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 independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shal
36、l attach to IEC or its directors, 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 lega
37、l 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 Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publ
38、ication. 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 responsible for identifying any or all such patent rights. International standard IEC 60601-2-36 has been prepared by IEC subcommittee 62D: E
39、lectromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendmen
40、t 1:2012). 4 IEC 60601-2-36:2014 IEC 2014 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/1109/FDIS 62D/1122/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above
41、 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 appearing outside of tables, such as notes, examples and
42、 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 CAPITALS. In referring to the structure of this standard, the term “clause” means one of the numbered divisions within t
43、he 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
44、 by the clause number. References to subclauses within this particular standard are by number only. In this standard, 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 standard conform to usage describ
45、ed 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 mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not man
46、datory 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 character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that it
47、em 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. IEC 60601-2-36:2014 IEC 2014 5 The committee has decided that the contents of this publication will remain unchanged until the stability date
48、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 amended. 6 IEC 60601-2-36:2014 IEC 2014 INTRODUCTION This particular standard concerns the BASI
49、C SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY. It amends and supplements IEC 60601-1/A1:2012 (Ed. 3.1): Medical electrical equipment Part 1: General requirements for basic safety and essential performance), hereinafter referred to as the general standard. The aim of this second edition is to bring this particular standard up to date with reference to the third edit
