CAN CSA-C22 2 NO 60601-2-1-2011 Medical electrical equipment Part 2-1 Particular requirements for the basic safety and essential performance of electron accelerators in the range .pdf

1、Medical electrical equipment Part2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeVAppareils lectromdicaux Partie 2-1: Exigences particulires de scurit de base et de performances essentielles pour les acclrateurs dlectron

2、s dans la gamme de1 MeV 50 MeVCAN/CSA-C22.2 No. 60601-2-1:11(IEC 60601-2-1:2009, IDT)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.CSA Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-1:11July 2011Title:Medical electrical equipment Part2-1: Pa

3、 rticular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeVPagination:141 pages (CSA/1CSA/13 and 128 text)To register for e-mail notification about any updates to this publicationgo to www.ShopCSA.caclick on E-mail Services under MY ACC

4、OUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publication is 2421287.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 person

5、al information.Service de mise jour desnormesCSACAN/CSA-C22.2 n 60601-2-1:11Juillet 2011Titre :Appareils lectromdicaux Pa rtie2-1: Exigences particulires de scurit de base et de performances essentielles pour les acclrateurs dlectrons dans la gamme de1 MeV 50 MeVNombre de pages :141 pages (CSA/1 CSA

6、/13 et 128 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.ShopCSA.cacliquez sur Services par courriel en dessous de MON COMPTEcliquez sur Service de mise jour des normes CSA Le numro didentification dont

7、 vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 2421287.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 pour

8、 savoir comment nous protgeons vos renseignements personnels.Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing vari

9、ed 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 independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis docum

10、ent is provided without any representations, warranties, or conditions of any kind, express or implied, including, 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

11、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 regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS

12、 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 EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINES

13、S 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 RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY

14、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 person or entity or to perform any duty owed by any person or entity to another person or entity. The informatio

15、n 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 and all use of or reliance on the information contained in this document. CSA is a private not-for-profit comp

16、any that publishes voluntary standards and related documents. CSA has no power, nor does it undertake, to enforce 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 p

17、rinted or electronic form), CSA is the owner, or the authorized licensee, of all works contained herein that 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 inven

18、tions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized 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 s

19、eek 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 rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of paten

20、t 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

21、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 computer for the sole purpose of reviewing it;.search and browse this document; and.print this document if it is in PD

22、F 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 each such copy.In addition, users may not and may not permit others to.alter this document in any way or remove

23、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 conditions contained in this Legal Notice, you may not load or use this document or make any copies of the conten

24、ts 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.Avis juridique concernant les normesLes normes de lAssociation canadienne de normalisation (CSA) sont labores sel

25、on 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 consensus et dlaborer une norme. Bien que la CSA assure ladministration de ce processus et dtermine les rgles qui favo

26、risent 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 assertion, garantie ni condition explicite ou implicite de quelque nature que ce soit, y compris, mais non de fa

27、on limitative, les garanties ou conditions implicites relatives la qualit marchande, ladaptation un usage particulier 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

28、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 VOLONTAIRES, SES MEMBRES, SES FILIALES OU SES SOCITS AFFILIES DE MME QUE LEURS EMPLOYS, LEURS DIRIGEANTS ET LEURS ADMI

29、NISTRATEURS NE PEUVENT EN AUCUN CAS TRE TENUS RESPONSABLES DE TOUTE BLESSURE, PERTE OU DPENSE OU DE TOUT PRJUDICE DIRECT, INDIRECT OU ACCESSOIRE, Y COMPRIS, MAIS NON DE FAON LIMITATIVE, TOUT PRJUDICE SPCIAL OU CONSCUTIF, TOUTE PERTE DE RECETTES OU DE CLIENTLE, TOUTE PERTE DEXPLOITATION, TOUTE PERTE

30、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 TIRANT SON ORIGINE DE QUELQUE FAON QUE CE SOIT DE LUTILISATION DE CE DOCUMENT ET CE, MME SI LA CSA A T AVISE DE LV

31、ENTUALIT DE TELS PRJUDICES. En publiant et en offrant ce document, la CSA nentend pas fournir des services professionnels ou autres au nom de quelque personne ou entit que ce soit, ni remplir les engagements que de telles personnes ou entits auraient pris auprs de tiers. Les renseignements prsents d

32、ans 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 quelque faon que ce soit de toute utilisation des renseignements contenus dans ce document ou de toute confiance

33、 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 et des autres documents quelle publie et ne possde pas lautorit ncessaire pour ce faire. Proprit et droits de pr

34、oprit 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 les marques de commerce ( moins dindication contraire) et de tous les documents contenus dans ce document, ces de

35、rniers tant protgs par les lois visant les droits dauteur. La CSA est galement propritaire ou titulaire de permis 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

36、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 ou dautres parties et donner ainsi droit lorganisme ou autre partie dexercer ses recours lgaux relativement un

37、e telle utilisation, modification, copie ou divulgation. Dans la mesure prvue par le permis ou la loi, la CSA 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 b

38、revet. 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 de brevet.Utilisations autorises de ce documentCe document est fourni par la CSA des fins informationnelles et n

39、on 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 documen

40、t ;. 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 de tels exemplaires et uniquement si le prsent avis juridique figure sur chacun deux.De plus, les utilisateurs

41、 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 ;.vendre ce document sans lautorisation de la CSA ;.faire une copie lectronique de ce document.Si vous tes en ds

42、accord avec lune ou lautre des dispositions du prsent avis juridique, vous ntes pas autoris tlcharger ou utiliser ce document, ni en reproduire le contenu, auquel cas vous tes tenu den dtruire toutes les copies. En utilisant ce document, vous confirmez que vous acceptez les dispositions du prsent av

43、is 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 to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership associati

44、on engaged in standards development and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce

45、and often adopted by municipal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, and associations across Canada indicate their support for CSAs standards development by volu

46、nteering their time and skills to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Sustaining memberships

47、represent a major source of income for CSAs standards development activities. The Association offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, the Association regularly and conti

48、nually audits and inspects products that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has developed the necessary

49、 expertise to meet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and internatio