CAN CSA-C22 2 NO 60601-2-52-2011 Medical electrical equipment Part 2-52 Particular requirements for the basic safety and essential performance of medical beds (First Edition Updat.pdf

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1、Medical electrical equipment Part 2-52: Particular requirements for the basic safety and essential performance of medical bedsAppareils lectromdicaux Partie 2-52 : Exigences particulires de scurit de base et de performances essentielles des lits mdicauxCAN/CSA-C22.2 No. 60601-2-52:11(IEC 60601-2-52:

2、2009, IDT/MOD)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE. / PUBLICATION NON DESTINE LA REVENTE.Update No. 1CAN/CSA-C22.2 No. 60601-2-52:11September 2012Note: For information about the Standards Update Service, go to shop.csa.ca or e-mail techsupportcsagroup.org.Title: Medical

3、 electrical equipment Part 2-52: Particular requirements for the basic safety and essential performance of medical beds originally published July 2011The following revisions have been formally approved and are marked by the symbol delta ( in the margin on the attached replacement pages:Revised CSA P

4、refaceNew NoneDeleted None Update your copy by inserting these revised pages.Keep the pages you remove for reference.Mise jour no1CAN/CSA-C22.2 n 60601-2-52:11Septembre 2012Note : Pour plus de renseignements sur le service de mise jour des normes, allez au shop.csa.ca ou envoyez un courriel au techs

5、upportcsagroup.org.Titre : Appareils lectromdicaux Partie 2-52 : Exigences particulires de scurit de base et de performances essentielles des lits mdicaux publie initialement en juillet 2011Les modifications qui suivent ont t officiellement approuves. Elles sont publies dans les feuilles rvises ci-j

6、ointes et sont indiques par le symbole delta ( dans la marge :Modification Prface CSAAjout AucunAbrogation AucuneInsrez les feuilles rvises dans votre exemplaire de la norme pour la tenir jour.Conservez les pages primes titre de rfrence.Reviewed byNational Standard of CanadaPublished in July 2011 by

7、 Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caPrepared byInternational Electrotechnical CommissionApproved byStandards Council of CanadaCA

8、N/CSA-C22.2 No. 60601-2-52:11Medical electrical equipment Part 2-52: Particular requirements for the basic safety and essential performance of medical bedsSeptember 2012 Canadian Standards AssociationCAN/CSA-C22.2 No. 60601-2-52:11Medical electrical equipment Part 2-52: Particular requirements for t

9、he basic safety and essential performance of medical bedsCAN/CSA-C22.2 No. 60601-2-52:11Medical electrical equipment Part 2-52: Particular requirements for the basic safety and essential performance of medical bedsCSA PrefaceThis is the first edition of CAN/CSA-C22.2 No. 60601-2-52, Medical electric

10、al equipment Part 2-52: Particular requirements for the basic safety and essential performance of medical beds, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-52 (first edition, 2009-12). This edition of CAN/CSA-C2

11、2.2 No. 60601-2-52 replaces CAN/CSA-C22.2 No. 60601-2-38:03, Medical electrical equipment Part 2: Particular requirements for the safety of electrically operated hospital beds (adopted CEI/IEC 601-2-38:1996). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical C

12、ode.This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, with Canadian deviations).This Standard is considered suitable for use for confor

13、mity assessment within the stated scope of the standard.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally app

14、roved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology. This Standard has been approved as

15、 a National Standard of Canada by the Standards Council of Canada.Interpretations: The Strategic Steering Committee on Requirements for Electrical Safety has provided the following direction for the interpretations of standards under its jurisdiction: “The literal text shall be used in judging compl

16、iance of products with the safety requirements of this Standard. When the literal text cannot be applied to the product, such as for new materials or construction, and when a relevant committee interpretation has not already been published, CSAs procedures for interpretation shall be followed to det

17、ermine the intended safety principle.”July 2011 Canadian Standards Association 2011All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. IEC material is reprinted with permission. Where the words “this International S

18、tandard” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.csa.

19、ca(Replaces p. CSA/8, July 2011)CSA/8Rvise parNorme nationale du Canadadition franaise publie en juillet 2011 par lAssociation canadienne de normalisation,un organisme sans but lucratif du secteur priv.5060, Spectrum Way, bureau 100, Mississauga (Ontario) Canada L4W 5N61-800-463-6727 416-747-4044Vis

20、itez notre boutique en ligne au www.ShopCSA.caPrpare parla Commission lectrotechnique InternationaleApprouve parle Conseil canadien des normesCAN/CSA-C22.2 n 60601-2-52:11Appareils lectromdicaux Partie 2-52 : Exigences particulires de scurit de base et de performances essentielles des lits mdicauxSe

21、ptembre 2012 Association canadienne de normalisationCAN/CSA-C22.2 n 60601-2-52:11Appareils lectromdicaux Partie 2-52 : Exigences particulires de scurit de base et de performances essentielles des lits mdicauxCAN/CSA-C22.2 n 60601-2-52:11Appareils lectromdicaux Partie 2-52 : Exigences particulires de

22、 scurit de base et de performances essentielles des lits mdicauxPrface CSACe document constitue la premire dition de la CAN/CSA-C22.2 n 60601-2-52, Appareils lectromdicaux Partie 2-52 : Exigences particulires de scurit de base et de performances essentielles des lits mdicaux. Il sagit de ladoption,

23、sans modifications, de la norme CEI (Commission lectrotechnique Internationale) 60601-2-52 (premire dition, 2009-12), qui porte le mme titre. Cette dition de la CAN/CSA-C22.2 n 60601-2-52 remplace la CAN/CSA-C22.2 n 60601-2-38:03, Appareils lectromdicaux Partie 2 : Rgles particulires de scurit des l

24、its dhpital lectriques (norme CEI/IEC 601-2-38:1996 adopte). Cette norme fait partie dune srie de normes publies par CSA lesquelles constituent le Code canadien de llectricit, Deuxime partie.Cette norme est conue pour tre utilise de concert avec la CAN/CSA-C22.2 n 60601-1:08, Appareils lectromdicaux

25、 Partie 1 : Exigences gnrales pour la scurit de base et les performances essentielles (norme CEI 60601-1:2005 adopte, avec exigences propres au Canada).Cette norme est juge convenable lvaluation de la conformit selon le domaine dapplication tabli dans la norme.Cette norme a t rvise en vue de son ado

26、ption pour le Canada par le Comit technique CSA sur les produits commerciaux et grand public, sous lautorit du Comit directeur stratgique CSA sur les exigences en matire de scurit lectricit, et a t officiellement approuve par le Comit technique. Parce que cette norme touche des concepts mdicaux, ell

27、e a aussi t approuve par le Comit technique CSA sur les installations lectriques dans les tablissements de sant sous lautorit du Comit directeur stratgique CSA sur la technologie des soins de sant. Cette norme a t approuve en tant que Norme nationale du Canada par le Conseil canadien des normes.Inte

28、rprtations : Le Comit directeur stratgique sur les exigences en matire de scurit lectricit a mis la directive qui suit quant linterprtation des normes qui relvent de sa comptence : Il convient de sappuyer sur le texte littral pour juger de la conformit des produits aux exigences de scurit de cette n

29、orme. Si le texte littral ne sapplique pas un produit, en raison dun nouveau matriel ou dune nouvelle construction, et si aucune interprtation pertinente na t produite par un comit CSA comptent, il convient de consulter les procdures CSA en matire dinterprtation afin de dterminer lintention quant au

30、 principe de scurit.Juillet 2011 Association canadienne de normalisation 2011Tous droits rservs. Aucune partie de cette publication ne peut tre reproduite par quelque moyen que ce soit sans la permission pralable de lditeur. Limpression du document CEI a t autorise. Si le texte dit cette Norme inter

31、nationale, le lecteur doit comprendre cette Norme nationale du Canada.CSA/12 (Remplace p. CSA/12, juillet 2011) CSA Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-52:11July 2011Title:Medical electrical equipment Part2-52: Part icular requirements for the basic safety and essential performance of

32、medical bedsPagination:181 pages (CSA/1CSA/13 and 168 text)To register for e-mail notification about any updates to this publicationgo to www.ShopCSA.caclick on E-mail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publica

33、tion is 2421303.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs policy on privacy at www.csagroup.org/legal to find out how we protect your personal information.Service de mise jour desnormesCSACAN/CSA-C22.2 n 60601-2-52:11Juillet 2011Titre :Appareils lectr

34、omdicaux Partie2-52:Exigences particulires descurit de base et de performances essentielles des lits mdicauxNombre de pages :181 pages (CSA/1 CSA/13 et 168 pages de texte)Vous devez vous inscrire pour recevoir les avis transmis par courriel au sujet des mises jour apportes ce document :allez au www.

35、ShopCSA.cacliquez sur Services par courriel en dessous de MON COMPTEcliquez sur Service de mise jour des normes CSA Le numro didentification dont vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 2421303.Si vous avez besoin daide, veuillez nous contacter par courrie

36、l au techsupportcsa.ca ou par tlphone au 416-747-2233.Consultez la politique de la CSA en matire de confidentialit au www.csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through

37、 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 process and establishes rules to promote fairness in

38、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, including, without limitation, implied warranties o

39、r 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 information published in this document. CSA makes

40、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 LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL

41、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, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY

42、 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 not undertaking to render professional or other

43、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 contents, and CSA accepts no responsibility what

44、soever 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 enforce compliance with the contents of the stand

45、ards 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 are protected by copyright, all trade-marks (e

46、xcept 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 unauthorized use, modification, copying, or disclosu

47、re 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 by law, CSA reserves all intellectual property

48、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 standard 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 following:If this document i

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