IEC 60601-2-22-2007 Medical electrical equipment - Part 2-22 Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic.pdf
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1、 INTERNATIONAL STANDARD IECCEINORME INTERNATIONALE60601-2-22Third editionTroisime dition2007-05Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Appareils lectromdicaux Partie 2
2、-22: Rgles particulires pour la scurit de base et les performances essentielles des appareils chirurgicaux, esthtiques, thrapeutiques et de diagnostic laser Reference number Numro de rfrence IEC/CEI 60601-2-22:2007 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All r
3、ights 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 from either IEC or IECs member National Committee in the country of the req
4、uester. 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 information. Droits de reproduction rservs. Sauf indication contraire, aucune parti
5、e 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 de la CEI du pays du demandeur. Si vous avez des questions sur le copyright
6、 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-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IE
7、C 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 technical content of IEC publications is kept under constant review by the
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15、ARD IECCEINORME INTERNATIONALE60601-2-22Third editionTroisime dition2007-05Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Appareils lectromdicaux Partie 2-22: Rgles particuli
16、res pour la scurit de base et les performances essentielles des appareils chirurgicaux, esthtiques, thrapeutiques et de diagnostic laser For price, see current cataloguePour prix, voir catalogue en vigueur PRICE CODE CODE PRIX U Commission Electrotechnique InternationaleInternational Electrotechnica
17、l Commission 2 60601-2-22 IEC:2007 CONTENTS FOREWORD.3 INTRODUCTION.5 201.1 Scope, object and related standards6 201.2 Normative references 8 201.3 Terms and definitions 8 201.4 General requirements10 201.5 General requirements for testing ME EQUIPMENT.10 201.6 Classification of ME EQUIPMENT and ME
18、SYSTEMS 10 201.7 ME EQUIPMENT identification, marking and documents10 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS13 201.10 Protection against unwanted and excessive radiation HAZARDS13 201.11 Protection a
19、gainst excessive temperatures and other HAZARDS15 201.12 Accuracy of controls and instruments and protection against hazardous outputs .15 201.13 HAZARDOUS SITUATIONS and fault conditions.16 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .18 201.15 Construction of ME EQUIPMENT .18 201.16 ME S
20、YSTEMS.18 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS19 Annexes .19 Annex D (informative) Symbols on marking19 Annex AA (informative) Particular guidance and rationale22 Bibliography24 Index of defined terms used in this particular standard25 Table D.1 General symbols19 60601
21、-2-22 IEC:2007 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is
22、 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. To this end and in addition to
23、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 National Committee interested in t
24、he 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 (ISO) in accordance with conditi
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