CAN CSA-C22 2 NO 60601-2-54-2011 Medical electrical equipment - Part 2-54 Particular requirements for the basic safety and essential performance of X-ray equipment for radiography .pdf

1、Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyAppareils lectromdicaux Partie2- 54:Exigences particulires pour lascurit de base et les performances essentielles des appareils rayonnement

2、X utiliss pour la radiographie et la radioscopieCAN/CSA-C22.2 No. 60601-2-54:11(IEC 60601-2-54:2009, IDT)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Update No. 1CAN/CSA-C22.2 No. 60601-2-54:11October 2014Note: For information about the Standa

3、rds Update Service, go to shop.csa.ca or e-mail techsupportcsagroup.org.Title: Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy originally published July 2011The following revisions have b

4、een formally approved and are marked by the symbol delta ( in the margin on the attached replacement pages:Revised CSA PrefaceNew NoneDeleted None Update your copy by inserting these revised pages.Keep the pages you remove for reference.Mise jour no1CAN/CSA-C22.2 n 60601-2-54:11Octobre 2014Note : Po

5、ur plus de renseignements sur le service de mise jour des normes, allez au shop.csa.ca ou envoyez un courriel au techsupportcsagroup.org.Titre : Appareils lectromdicaux Partie 2-54 : Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X utiliss po

6、ur la radiographie et la radioscopie publie initialement en juillet 2011Les modifications qui suivent ont t officiellement approuves. Elles sont publies dans les feuilles rvises ci-jointes et sont indiques par le symbole delta ( dans la marge :Modification Prface CSAAjout AucunAbrogation AucuneInsre

7、z les feuilles rvises dans votre exemplaire de la norme pour la tenir jour.Conservez les pages primes titre de rfrence.Blank page Page blancheReviewed byNational Standard of CanadaPublished in July 2011 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, S

8、uite 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 CanadaCAN/CSA-C22.2 No. 60601-2-54:11Medical electrical equipment Part 2-54: Particular requirements fo

9、r the basic safety and essential performance of X-ray equipment for radiography and radioscopyCAN/CSA-C22.2 No. 60601-2-54:11Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyCSA/8 2014 CSA

10、Group (Replaces p. CSA/8, July 2011)October 2014 CAN/CSA-C22.2 No. 60601-2-54:11Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyCSA PrefaceThis is the first edition of CAN/CSA-C22.2 No. 60

11、601-2-54, Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 606

12、01-2-54 (first edition, 2009-06). It replaces CAN/CSA-C22.2 No. 60601-2-7-01 (adopted CEI/IEC 60601-2-7:1998) and CAN/CSA-C22.2 No. 601.2.32-98 (adopted CEI/IEC 601-2-32:1994). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.This Standard is intended to

13、 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 conformity assessment within the state

14、d 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 Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Du

15、e 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 Strategic Steering Committee on Health Care Technology. This Standard has been approved as a National Standard of Canada by the St

16、andards 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 compliance of products with the safety requir

17、ements 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 determine the intended safety principle.”Ju

18、ly 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 Standard” appear in the text, they should

19、 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.caRvise parNorme nationale du Canadaditi

20、on 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 416-747-4044Visitez notre boutique en ligne au www.ShopCSA.caPrpare parla Commission lectr

21、otechnique InternationaleApprouve parle Conseil canadien des normesCAN/CSA-C22.2 n 60601-2-54:11Appareils lectromdicaux Partie 2-54 : Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographie et la radioscopieCAN/CSA-C22.2

22、 n 60601-2-54:11Appareils lectromdicaux Partie 2-54 : Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographie et la radioscopieCSA/12 2014 Groupe CSA (Remplaces p. CSA/12, juillet 2011)Octobre 2014CAN/CSA-C22.2 n 60601-2

23、-54:11Appareils lectromdicaux Partie 2-54 : Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographie et la radioscopiePrface CSACe document constitue la premire dition de la CAN/CSA-C22.2 n 60601-2-54, Appareils lectromdi

24、caux Partie 2-54 : Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographie et la radioscopie. Il sagit de ladoption, sans modifications, de la norme CEI (Commission lectrotechnique Internationale) 60601-2-54 (premire dit

25、ion, 2009-06), qui porte le mme titre. Cette norme remplace la CAN/CSA-C22.2 n 60601-2-7-01 (norme CEI/IEC 60601-2-7:1998 adopte) et la CAN/CSA-C22.2 n 601.2.32-98 (norme CEI/IEC 601-2-32:1994 adopte). Cette norme fait partie dune srie de normes publies par CSA lesquelles constituent le Code canadie

26、n de llectricit, Deuxime partie.Cette norme est conue pour tre utilise de concert avec la norme CAN/CSA-C22.2 n 60601-1:08, Appareils lectromdicaux Partie 1 : Exigences gnrales pour la scurit de base et les performances essentielles (norme CEI 60601-1:2005 adopte, avec exigences propres au Canada).C

27、ette 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 adoption pour le Canada par le Comit technique CSA sur les produits commerciaux et grand public, sous lautorit du Comit directeur stratgique sur les exigenc

28、es en matire de scurit lectricit, et a t officiellement approuve par le Comit technique. Parce que cette norme touche des concepts mdicaux, elle a aussi t approuve par le Comit technique CSA sur les installations lectriques dans les tablissements de sant sous lautorit du Comit directeur stratgique s

29、ur la technologie des soins de sant. Cette norme a t approuve en tant que Norme nationale du Canada par le Conseil canadien des normes.Interprtations : Le Comit directeur stratgique sur les exigences en matire de scurit lectricit a mis la directive qui suit quant linterprtation des normes qui relven

30、t de sa comptence : Il convient de sappuyer sur le texte littral pour juger de la conformit des produits aux exigences de scurit de cette norme. 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 pr

31、oduite par un comit CSA comptent, il convient de consulter les procdures CSA en matire dinterprtation afin de dterminer lintention quant au principe de scurit.Juillet 2011CSA Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-54:11July 2011Title:Medical electrical equipment Part2-54: Part icular requ

32、irements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyPagination:154 pages (CSA/1CSA/13 and 141 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 S

33、tandards Update ServiceThe List ID that you will need to register for updates to this publication is 2421288.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.Ser

34、vice de mise jour desnormesCSACAN/CSA-C22.2 n 60601-2-54:11Juillet 2011Titre :Appareils lectromdicaux Partie2-54:Exigences particulires pour lascurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographie et la radioscopieNombre de pages :154 pages (CSA/1 C

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36、nt vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 2421288.Si vous avez besoin daide, veuillez nous contacter par courriel 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 po

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