CAN CSA-C22 2 NO 60601-2-22-2008 Medical electrical equipment – Part 2-22 Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and di.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 National Standard of CanadaCAN/CSA-C22.2 No. 60601-2-22:08(IEC 60601-2-22:2007)Norme

3、nationale du CanadaInternational Standard IEC 60601-2-22:2007 (third edition, 2007-05) has been adopted withoutmodification (IDT) as CSA Standard CAN/CSA-C22.2 No. 60601-2-22:08, which has been approved as aNational Standard of Canada by the Standards Council of Canada.ISBN 978-1-55491-043-4 Decembe

4、r 2008La Norme internationale IEC 60601-2-22:2007 (troisime dition, 2007-05) adopte sans modifications(IDT) porte la dsignation CAN/CSA-C22.2 n 60601-2-22:08. Elle a t approuve en tant que Normenationale du Canada par le Conseil canadien des normes.ISBN 978-1-55491-043-4 Dcembre 2008 International E

5、lectrotechnical Commission (IEC), 2007. All rights reserved. NOT FOR RESALE. Commission lectrotechnique Internationale (CEI), 2007. Tous droits rservs. PUBLICATION NON DESTINE LA REVENTE.THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All rights reserved. Unless other

6、wise 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 requester. If you have any ques

7、tions 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 partie de cette publication ne pe

8、ut 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 de la CEI ou si vous dsirez

9、 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 IEC The International Electrot

10、echnical 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 IEC. Please make sure that y

11、ou 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 of criteria (reference number, text, technical committee,). It also gives information on projects, with

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18、sociation (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA administers the proces

19、s and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, incl

20、uding, without limitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringement of any third partys intellectual property rights. CSA does not warrant the accuracy, completeness, or currency of any of the inf

21、ormation published in this document. CSA makes no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE

22、LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, T

23、ORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA is n

24、ot undertaking to render professional or other services for or on behalf of any person or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its c

25、ontents, and CSA accepts no responsibility whatsoever arising in any way from any and all use of or reliance on the information contained in this document. CSA is a private not-for-profit company that publishes voluntary standards and related documents. CSA has no power, nor does it undertake, to en

26、force compliance with the contents of the standards or other documents it publishes. Intellectual property rights and ownershipAs between CSA and the users of this document (whether it be in printed or electronic form), CSA is the owner, or the authorized licensee, of all works contained herein that

27、 are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and all inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unaut

28、horized use, modification, copying, or disclosure of this document may violate laws that protect CSAs and/or others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or

29、by law, CSA reserves all intellectual property rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA shall not be held responsible for identifying any or all such patent rights. Users of this sta

30、ndard are expressly advised that determination of the validity of any such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA for informational and non-commercial use only. The user of this document is authorized to do only the fo

31、llowing:If this document is in electronic form:.load this document onto a computer for the sole purpose of reviewing it;.search and browse this document; and.print this document if it is in PDF format. Limited copies of this document in print or paper form may be distributed only to persons who are

32、authorized by CSA to have such copies, and only if this Legal Notice appears on each such copy.In addition, users may not and may not permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an

33、electronic copy of this document.If you do not agree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this documen

34、t constitutes your acceptance of the terms and conditions of this Legal Notice.Avis juridique concernant les normesLes normes de lAssociation canadienne de normalisation (CSA) sont labores selon un processus consensuel approuv par le Conseil canadien des normes. Ce processus rassemble des volontaire

35、s reprsentant diffrents intrts et points de vue dans le but datteindre un consensus et dlaborer une norme. Bien que la CSA assure ladministration de ce processus et dtermine les rgles qui favorisent lquit dans la recherche du consensus, elle ne met pas lessai, ni nvalue ou vrifie de faon indpendante

36、 le contenu de ces normes.Exclusion de responsabilitCe document est fourni sans assertion, garantie ni condition explicite ou implicite de quelque nature que ce soit, y compris, mais non de faon limitative, les garanties ou conditions implicites relatives la qualit marchande, ladaptation un usage pa

37、rticulier ainsi qu labsence de violation des droits de proprit intellectuelle des tiers. La CSA ne fournit aucune garantie relative lexactitude, lintgralit ou la pertinence des renseignements contenus dans ce document. En outre, la CSA ne fait aucune assertion ni ne fournit aucune garantie quant la

38、conformit de ce document aux lois et aux rglements pertinents.LA CSA, SES VOLONTAIRES, SES MEMBRES, SES FILIALES OU SES SOCITS AFFILIES DE MME QUE LEURS EMPLOYS, LEURS DIRIGEANTS ET LEURS ADMINISTRATEURS NE PEUVENT EN AUCUN CAS TRE TENUS RESPONSABLES DE TOUTE BLESSURE, PERTE OU DPENSE OU DE TOUT PRJ

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42、ettre en application ce contenu. La CSA rejette toute responsabilit dcoulant de quelque faon que ce soit de toute utilisation des renseignements contenus dans ce document ou de toute confiance place en ceux-ci.La CSA est un organisme priv sans but lucratif qui publie des normes volontaires et des do

43、cuments connexes. La CSA nentend pas imposer la conformit au contenu des normes et des autres documents quelle publie et ne possde pas lautorit ncessaire pour ce faire. Proprit et droits de proprit intellectuelleTel que convenu entre la CSA et les utilisateurs de ce document (quil soit imprim ou sur

44、 support lectronique), la CSA est propritaire ou titulaire de permis de toutes les marques de commerce ( moins dindication contraire) et de tous les documents contenus dans ce document, ces derniers tant protgs par les lois visant les droits dauteur. La CSA est galement propritaire ou titulaire de p

45、ermis de toutes les inventions et de tous les secrets commerciaux que pourrait contenir ce document, quils soient ou non protgs par des brevets ou des demandes de brevet. Sans que soit limite la porte gnrale du paragraphe, lutilisation, la modification, la copie ou la divulgation non autorise de ce

46、document pourrait contrevenir aux lois visant la proprit intellectuelle de la CSA ou dautres parties et donner ainsi droit lorganisme ou autre partie dexercer ses recours lgaux relativement une telle utilisation, modification, copie ou divulgation. Dans la mesure prvue par le permis ou la loi, la CS

47、A conserve tous les droits de proprit intellectuelle relatifs ce document.Droits de brevetVeuillez noter quil est possible que certaines parties de cette norme soient vises par des droits de brevet. La CSA ne peut tre tenue responsable didentifier tous les droits de brevet. Les utilisateurs de cette

48、 norme sont aviss que cest eux quil incombe de vrifier la validit de ces droits de brevet.Utilisations autorises de ce documentCe document est fourni par la CSA des fins informationnelles et non commerciales seulement. Lutilisateur de ce document nest autoris qu effectuer les actions dcrites ci-dessous.Si le document est prsent sur support lectronique, lutilisateur est autoris :.tlcharger ce document sur un ordinateur dans le seul but de le consulter ;.consulter et parcourir ce document ;.imprimer ce document si cest une version PDF.Un nombre limit dexemplaires imprims ou lectroniques

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