IEC 60601-2-57-2011 Medical electrical equipment - Part 2-57 Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for.pdf

1、 IEC 60601-2-57 Edition 1.0 2011-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic u

2、se Appareils lectromdicaux Partie 2-57: Exigences particulires pour la scurit de base et les performances essentielles des appareils source de lumire non-laser prvus pour des utilisations thrapeutiques, de diagnostic, de surveillance et de cosmtique/esthtique IEC60601-2-57:2011 colourinsideTHIS PUBL

3、ICATION IS COPYRIGHT PROTECTED Copyright 2011 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 in writing

4、 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 further informa

5、tion. 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 la CEI ou du Comit national

6、 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 Comit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH

7、-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: 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 technologies. About IEC publications The

8、 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. Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety

9、 of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released.

10、 Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Ele

11、ctrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further 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 prop

12、os 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. A propos des publications CEI Le contenu technique des publications

13、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 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

14、diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications retires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois l

15、es nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 20 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans

16、les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-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 co

17、ntactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60601-2-57 Edition 1.0 2011-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment

18、 intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use Appareils lectromdicaux Partie 2-57: Exigences particulires pour la scurit de base et les performances essentielles des appareils source de lumire non-laser prvus pour des utilisations thrapeutiques, de diagnostic, de surve

19、illance et de cosmtique/esthtique INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE V ICS 11.040.50; 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-88912-344-5 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotec

20、hnique Internationale colourinside 2 60601-2-57 IEC:2011 CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards 8 201.2 Normative references 10 201.3 Terms and definitions 10 201.4 General requirements 13 201.5 General requirements for testing ME EQUIPMENT . 13 201.6 Classi

21、fication of ME EQUIPMENT and ME SYSTEMS . 13 201.7 ME EQUIPMENT identification, marking and documents 15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 19 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 20 201.10 Protection against unwanted and excessive rad

22、iation HAZARDS 20 201.11 Protection against excessive temperatures and other HAZARDS 21 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 21 201.13 HAZARDOUS SITUATIONS and fault conditions . 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23 201.15 Co

23、nstruction of ME EQUIPMENT . 23 201.16 ME SYSTEMS. 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 23 Annexes . 23 Annex AA (informative) Particular guidance and rationale 24 Annex BB (informative) Exposure limit values 26 Annex CC (informative) Protective eyewear for LS EQUIP

24、MENT 30 Annex DD (informative) Summary of MANUFACTURERS requirements 31 Annex EE (informative) Symbols on marking 32 Bibliography 33 Index of defined terms used in this particular standard 34 Figure 201.101 Example of explanatory label for a device with multiple HAZARD spectral regions 18 Figure 201

25、.102 Warning label HAZARD symbol . 19 Table 201.101 EMISSION LIMITS for risk groups of LS EQUIPMENT 14 Table 201.102 Risk group time base criteria for classification of LS EQUIPMENT 15 Table 201.103 Applicable ANGLE OF ACCEPTANCE for the assessment of accessible emission from LS EQUIPMENT . 15 Table

26、 201.104 Requirements for labelling of LS EQUIPMENT according to risk group classification . 17 Table BB.1 EXPOSURE LIMIT values for non-coherent OPTICAL RADIATION . 26 Table BB.2 S() dimensionless, 200 nm to 400 nm 28 Table BB.3 B (), R () dimensionless, 300 nm to 1 400 nm . 29 60601-2-57 IEC:2011

27、3 Table DD.1 Summary of MANUFACTURERS requirements . 31 Table EE.1 Symbols, references and descriptions 32 4 60601-2-57 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-57: Particular requirements for the basic safety and essential performance of non-laser lig

28、ht source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of

29、 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, Technical Specifications, Technical Reports, Publicly Available Specifications (P

30、AS) 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 preparatory work. International, governmental and non-governmental organizations liaising wi

31、th 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 organizations. 2) The formal decisions or agreements of IEC on technical matters express, as n

32、early 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 recommendations for international use and are accepted by IEC National Committees in t

33、hat 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 any end user. 4) In order to promote international uniformity, IEC National Committ

34、ees 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 publication shall be clearly indicated in the latter. 5) IEC itself does not provide

35、 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 independent certification bodies. 6) All users should ensure that they have the latest

36、 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, property damage or other damage of any nature whatsoever, whethe

37、r 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 in this publication. Use of the referenced publications is indi

38、spensable 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 any or all such patent rights. International Standard IEC 60601

39、-2-57 has been prepared by IEC technical committee TC 76: Optical radiation safety and laser equipment The text of this standard is based on the following documents: FDIS Report on voting 76/438/FDIS 76/441/RVD Full information on the voting for the approval of this standard can be found in the repo

40、rt on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: 60601-2-57 IEC:2011 5 Requirements and definitions: roman type. Test specifications: italic type. Informative material

41、 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 standard, the t

42、erm “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). References to clau

43、ses 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 conditions is tr

44、ue. 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” means that co

45、mpliance 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 or table tit

46、le 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. 6 60601-2-57 IEC:2011 The committee has decided that the contents of this p

47、ublication 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 amended. IMPORTANT The colour inside

48、logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer. 60601-2-57 IEC:2011 7 INTRODUCTION This particular standard amends and sup

49、plements IEC 60601-1:2005 (third edition): Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance. The requirements of this particular standard should be taken as the minimum to comply with, in order to achieve a reasonable level of safety and reliability during operation and application of non-laser light source equ