IEC 60601-2-41-2009 Medical electrical equipment - Part 2-41 Particular requirements for basic safety and essential performance of surgical luminaires and lumin.pdf

1、 IEC 60601-2-41Edition 2.0 2009-08INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis Appareils lectromdicaux Partie 2-41: Exigences particulires

2、pour la scurit de base et les performances essentielles des clairages chirurgicaux et des clairages de diagnostic IEC60601-2-41:2009 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be rep

3、roduced 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 about obt

4、aining 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 que ce

5、 soit et par aucun procd, lectronique ou mcanique, y compris 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 publicati

6、on, utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organi

7、zation 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 edition, a corrigenda or an amendme

8、nt might have been published. Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: w

9、ww.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing mo

10、re than 20 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need furthe

11、r assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des normes internationales pour tou

12、t ce qui a trait llectricit, llectronique et aux technologies apparentes. 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. Catalogue des

13、publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications retires ou remplaces. Just Pub

14、lished CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnaire en ligne au monde de term

15、es lectroniques et lectriques. Il contient plus de 20 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-

16、f.htm Si vous dsirez nous donner des commentaires sur 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 60601-2-41Edition 2.0 2009-08INTERNATIONAL STANDARD NORME INTERNATIONALEMedical

17、 electrical equipment Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis Appareils lectromdicaux Partie 2-41: Exigences particulires pour la scurit de base et les performances essentielles des clairages chirurgicaux e

18、t des clairages de diagnostic INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE WICS 11.040.20; 11.040.55; 11.040.99 PRICE CODECODE PRIXISBN 2-8318-1054-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotec

19、hnique Internationale 2 60601-2-41 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.6 201.1 Scope, object and related standards7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements12 201.5 General requirements for testing of ME EQUIPMENT .13 201.6 Classification of ME EQUI

20、PMENT and ME SYSTEMS 13 201.7 ME EQUIPMENT Identification, marking and documents.14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT15 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS .15 201.10 Protection against unwanted and excessive radiation HAZARDS 18 201

21、11 Protection against excessive temperatures and other HAZARDS 18 201.12 Accuracy of controls and instruments and protection against hazardous outputs 19 201.13 HAZARDOUS SITUATIONS and fault conditions .33 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)33 201.15 Construction of ME EQUIPMENT

22、33 201.16 ME SYSTEMS .33 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS33 Annex AA (informative) Guidance and rationale for particular clauses and subclauses.35 Bibliography38 Index of defined terms 39 Figure 201.101 Example of power supplies for SURGICAL LUMINAIRES 10 Figure 2

23、01.102 DETACHABLE HANDLE attachment and detachment tests.16 Figure 201.103 Test for ease of motion17 Figure 201.104 Light distribution22 Figure 201.105 CENTRAL ILLUMINANCE measurement.24 Figure 201.106 Measurements of LIGHT FIELD DIAMETER and diameter at 50 % of CENTRAL ILLUMINANCE 24 Figure 201.107

24、 Illuminance measurement with one mask.25 Figure 201.108 Illuminance measurement with two masks .25 Figure 201.109 Illuminance measurement with four different positions of the two masks.26 Figure 201.110 Tube for illuminance measurement 27 Figure 201.111 Detail of the inner surface of the tube (exam

25、ple) .27 Figure 201.112 Illuminance measurement at the bottom of a cavity, with one mask .28 Figure 201.113 Illuminance measurement at the bottom of a cavity, with two masks 29 Figure 201.114 Illuminance measurement at the bottom of a cavity, with four different positions of the two masks30 Figure 2

26、01.115 Measurement of DEPTH OF ILLUMINATION .31 Figure AA.1 Changeover cycle to an emergency backup system 36 60601-2-41 IEC:2009 3 Table 201.101 Classification of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS12 Table 201.102 Distributed ESSENTIAL PERFORMANCE requirements 13 Table 201.103 Allowab

27、le maximum temperatures for ME EQUIPMENT parts that are likely to be touched.19 4 60601-2-41 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for d

28、iagnosis 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 standardizati

29、on in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC

30、 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 International Organization for Standardizati

31、on (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 representa

32、tion 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 cann

33、ot 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 publication

34、s. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC P

35、ublication. 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 any personal injury,

36、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 Normative references cited

37、 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 responsible for identifying

38、 any or all such patent rights. International standard IEC 60601-2-41 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 2000. This edition c

39、onstitutes a technical revision to be consistent with the third edition of the IEC 60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/773/FDIS 62D/787/RVD Full information on the voting for the approval of this particular standard can be foun

40、d in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 60601-2-41 IEC:2009 5 In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informa

41、tive 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 CAPITALS. In referring to the structure of this st

42、andard, 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 and 7.2.1 are all subclauses of Clause 7). Refer

43、ences to clauses within this standard are preceded by the term “Clause” followed 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 con

44、ditions 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 mandatory for compliance with this standard; “should”

45、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 character of a title or at the beginning of a paragraph

46、 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 has decided that the contents of this publicatio

47、n will remain unchanged until the maintenance result 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 amended. 6 60601-2-41 IEC:2009 INTROD

48、UCTION This particular standard concerns the basic safety and essential performance of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS. It amends and supplements IEC 60601-1 (third Edition 2005), hereinafter referred to as the general standard. The requirements of this particular standard take prio

49、rity over those of the general standard, entitled “Medical electrical equipment Part 1: General requirements for basic safety and essential performance. 60601-2-41 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis 201.1 Scope, object and re