CAN CSA-C22 2 NO 60601-2-45-2011 Medical electrical equipment Part 2-45 Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and .pdf

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1、Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devicesAppareils lectromdicaux Partie2-45: Exigences particulires pour la scurit de base et les performances essentielles des a

2、ppareils de mammographie rayonnement X et des appareils mammographiques strotaxiquesCAN/CSA-C22.2 No. 60601-2-45:11(IEC 60601-2-45:2011, IDT)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.CSA Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-45:

3、11November 2011Title:Medical electrical equipment Part2-45: Part icular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devicesPagination:116 pages (CSA/1CSA/13 and 103 text)To register for e-mail notification about any update

4、s to this publicationgo on-line to shop.csa.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 publication is 2421435.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs

5、 policy on privacy at csagroup.org/legal to find out how we protect your personal information.Service de mise jour desnormesCSACAN/CSA-C22.2 n 60601-2-45:11Novembre 2011Titre :Appareils lectromdicaux Pa rtie2-45: Exigences particulires pour la scurit de base et les performances essentielles des appa

6、reils de mammographie rayonnement X et des appareils mammographiques strotaxiquesNombre de pages :116 pages (CSA/1 CSA/13 et 103 pages de texte)Vous devez vous inscrire pour recevoir les avis transmis par courriel au sujet des mises jour apportes ce document :allez au shop.csa.cacliquez sur Services

7、 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 2421435.Si vous avez besoin daide, veuillez nous contacter par courriel au techsupportcsa.ca ou par

8、tlphone au 416-747-2233.Consultez la politique de la CSA en matire de confidentialit au csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development

9、 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 achieving consensus, it does not i

10、ndependently 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 or conditions concerning this docum

11、ents 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 no representations or warranties r

12、egarding 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 DAMAGES, INJURY, LOSS, COSTS, OR E

13、XPENSES, 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 OF LIABILITY, ARISING OUT OF OR R

14、ESULTING 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 services for or on behalf of any p

15、erson 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 whatsoever arising in any way from any

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19、ws 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 rights in this document.Patent rig

20、htsAttention 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

21、 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 is in electronic form:.load this document onto a compute

22、r 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 authorized by CSA to have such copies, and only if this Legal Notice appears on e

23、ach 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 electronic copy of this document.If you do not agree with any of the terms and co

24、nditions 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 document constitutes your acceptance of the terms and conditions of this Legal Notice.Av

25、is 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 volontaires reprsentant diffrents intrts et points de vue dans le but datteindre un consens

26、us 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 le contenu de ces normes.Exclusion de responsabilitCe document est fourni sans a

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28、 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 conformit de ce document aux lois et aux rglements pertinents.LA CSA, SES VOLONTA

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30、T PRJUDICE SPCIAL OU CONSCUTIF, TOUTE PERTE DE RECETTES OU DE CLIENTLE, TOUTE PERTE DEXPLOITATION, TOUTE PERTE OU ALTRATION DE DONNES OU TOUT AUTRE PRJUDICE CONOMIQUE OU COMMERCIAL, QUIL SOIT FOND SUR UN CONTRAT, UN DLIT CIVIL (Y COMPRIS LE DLIT DE NGLIGENCE) OU TOUT AUTRE LMENT DE RESPONSABILIT TIR

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32、ir les engagements que de telles personnes ou entits auraient pris auprs de tiers. Les renseignements prsents dans ce document sont destins aux utilisateurs qui possdent le niveau dexprience ncessaire pour utiliser et mettre en application ce contenu. La CSA rejette toute responsabilit dcoulant de q

33、uelque 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 documents connexes. La CSA nentend pas imposer la conformit au contenu des normes e

34、t 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 support lectronique), la CSA est propritaire ou titulaire de permis de toutes le

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36、ntenir 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 document pourrait contrevenir aux lois visant la proprit intellectuelle de la CSA

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38、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 norme sont aviss que cest eux quil incombe de vrifier la validit de ces droits d

39、e 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 :

40、. 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 de ce document peuvent tre distribus aux seules personnes autorises par la CSA possder

41、 de tels exemplaires et uniquement si le prsent avis juridique figure sur chacun deux.De plus, les utilisateurs ne sont pas autoriss effectuer, ou permettre quon effectue, les actions suivantes :.modifier ce document de quelque faon que ce soit ou retirer le prsent avis juridique joint ce document ;

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43、ire toutes les copies. En utilisant ce document, vous confirmez que vous acceptez les dispositions du prsent avis juridique.The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada

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