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本文(CAN CSA-C22 2 NO 60601-2-25-2012 Medical electrical equipment - Part 2-25 Particular requirements for the basic safety and essential performance of electrocardiographs (Second Edit.pdf)为本站会员(diecharacter305)主动上传,麦多课文库仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文库(发送邮件至master@mydoc123.com或直接QQ联系客服),我们立即给予删除!

CAN CSA-C22 2 NO 60601-2-25-2012 Medical electrical equipment - Part 2-25 Particular requirements for the basic safety and essential performance of electrocardiographs (Second Edit.pdf

1、Medical electrical equipment Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographsAppareils lectromdicaux Partie 2-25 : Exigences particulires pour la scurit de base et les performances essentielles des lectrocardiographesCAN/CSA-C22.2 No. 60601-2-2

2、5:12(IEC 60601-2-25:2011, MOD)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE. / PUBLICATION NON DESTINE LA REVENTE.Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-25:12July 2012Title: Medical electrical equipment Part 2-25: Particular requirements for the basic safety and essen

3、tial performance of electrocardiographsPagination: 210 pages (CSA/1CSA/14 and 196 text)To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2421821.If you req

4、uire assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.Service de mise jour desnormesCAN/CSA-C22.2 n 60601-2-25:12Juillet 2012Titre : Appareils lectromdicaux Partie 2-25

5、 : Exigences particulires pour la scurit de base et les performances essentielles des lectrocardiographesNombre de pages : 210 pages (CSA/1 CSA/14 et 196 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.c

6、sa.cacliquez sur Service de mises jourLe numro didentification dont vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 2421821.Si vous avez besoin daide, veuillez nous contacter par courriel au techsupportcsagroup.org ou par tlphone au 416-747-2233.Consultez la polit

7、ique du Groupe CSA en matire de confidentialit au csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.Legal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by t

8、he Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus, it does not independently tes

9、t, 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 documents fitness for

10、 a particular purpose or use, its merchantability, or its non-infringement of any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA Group makes no representations or warranties regar

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

12、 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 OF LIABILITY, ARISING OUT OF OR

13、 RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA GROUP HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA Group is not undertaking to render professional or other services for or on b

14、ehalf 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 Group accepts no responsibility whatsoever arising

15、 in any way from any and all use of or reliance on the information contained in this document. CSA Group is a private not-for-profit company that publishes voluntary standards and related documents. CSA Group has no power, nor does it undertake, to enforce compliance with the contents of the standar

16、ds or other documents it publishes. Intellectual property rights and ownershipAs between CSA Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trad

17、e-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 unauthorized use, modification, copying, o

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

19、s 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 Group shall not be held responsible for identifying any or all such patent rights. Users of this standard are exp

20、ressly 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 Group for informational and non-commercial use only. The user of this document is authorized to do only the following

21、:If this document is in electronic form:sLOADTHISDOCUMENTONTOACOMPUTERFORTHESOLEPURPOSEOFREVIEWINGITsSEARCHANDBROWSETHISDOCUMENTANDsPRINTTHISDOCUMENTIFITISIN0$ this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of capable individuals whose collective inter

22、ests provide, to the greatest practicable extent, a balance of representation of general interests, producers, regulators, users (including consumers), and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant

23、 and timely contribution to the national interest.Those who have a need to apply standards areencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO which publishes the standard.The responsibility for approving stan

24、dards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard is stated in its Scope, it is impor

25、tantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”exerce ses activits sous le nom Groupe CSA),sous les auspices de laquelle cette Norme nationale a LAssociati

26、on canadienne de normalisation (quit prpare, a reu ses lettres patentes en 1919 et son accrditation au sein du Systme de Normes nationales par le Conseil canadien des normes en 1973. Association daffiliation libre, sans but lucratif ni pouvoir de rglementation, le Groupe CSA se consacre llaborationd

27、e normes et la certification. Les normes du Groupe CSA refltent le consensus de producteurs et dusagers de partout au pays, au nombredesquels se trouvent des fabricants, des consommateurs, des dtaillants et des reprsentants de syndicats, de corps professionnels et dagences gouvernementales. Lutilisa

28、tion des normes du Groupe CSA est trs rpandue dans lindustrie et le commerce, et leur adoption diversordres de lgislation, tant municipal et provincial quefdral, est chose courante, particulirement dans lesdomaines de la sant, de la scurit, du btiment, de laconstruction et de lenvironnement. Les Can

29、adiens dun bout lautre du pays tmoignent de leur appui au travail de normalisation men par leGroupe CSA en participant bnvolement aux travaux descomits du Groupe CSA et en appuyant ses objectifs par leurs cotisations de membres de soutien. Les quelque 7000 volontaires faisant partie des comits et le

30、s 2000 membres de soutien constituent lensemble des membres du Groupe CSA parmi lesquels ses administrateurssont choisis. Les cotisations des membres de soutienreprsentent une source importante de revenu pour lesservices de soutien la normalisation volontaire. Le Groupe CSA offre des services de cer

31、tification et demise lessai qui appuient et compltent ses activits dans ledomaine de llaboration de normes. De manire assurer lintgrit de son processus de certification, le Groupe CSA procde de faon rgulire et continue lexamen et linspection des produits portant la marque du Groupe CSA. Outre son si

32、ge social et ses laboratoires Toronto, le Groupe CSA possde des bureaux rgionaux dans descentres vitaux partout au Canada, de mme que des agences dinspection et dessai dans huit pays. Depuis 1919, le Groupe CSA a parfait les connaissances techniques qui lui permettent de remplir sa mission dentrepri

33、se, savoir le Groupe CSA est un organisme de services indpendantdont la mission est doffrir une tribune libre et efficace pourla ralisation dactivits facilitant lchange de biens et de services par lintermdiaire de services de normalisation, de certification et autres, pour rpondre aux besoins de nos

34、 clients, tant lchelle nationale quinternationale.Pour plus de renseignements sur les services du Groupe CSA, sadresser auGroupe CSA5060, Spectrum Way, bureau 100Mississauga (Ontario) L4W 5N6CanadaLe Conseil canadien des normes (CCN) coordonne le Systme national de normes, une coalition dorganismes

35、indpendants et autonomes qui se consacrent au dveloppement et lamlioration de la normalisation volontaire dans lintrt national.Les principaux buts du CCN sont dencourager et de favoriser la normalisation volontaire en vue de dvelopper lconomie nationale, damliorer la sant, la scurit et le bien-tre d

36、u public, daider et de protger le consommateur, de faciliter le commerce intrieur et extrieur et de promouvoir la coopration internationale dans le domaine des normes.Une Norme nationale du Canada (NNC) est une norme prpare ou examine par un organisme dlaboration de normes (OEN) accrdit et approuve

37、par le CCN selon les exigences de CAN-P-2. Lapprobation ne porte pas sur laspect technique de la norme ; cet aspect demeurant la responsabilit permanente de lOEN. Toute NNC reflte un consensus raisonnable parmi les points de vue dun certain nombre de personnes comptentes dont les intrts runis formen

38、t, au degr le plus lev possible, une reprsentation quilibre des intrts des producteurs, des organismes de rglementation, des utilisateurs (y compris les consommateurs) et dautres personnes intresses, selon le domaine envisag. Il sagit gnralement dune norme qui peut apporter une contribution apprciab

39、le, en temps opportun, lintrt national.Il est recommand aux personnes qui ont besoin de normes de se servir des Normes nationales du Canada. Ces normes font lobjet dexamens priodiques; cest pourquoi lon recommande aux utilisateurs de se procurer ldition la plus rcente de la norme auprs de lorganisme

40、 qui la publie.La responsabilit dapprouver les normes en tant que Normes nationales du Canada incombe au :Conseil canadien des normes270, rue Albert, bureau 200Ottawa (Ontario) K1P 6N7CanadaThis National Standard of Canada is available in English and French.Bien que le but premier vis par cette norm

41、e soit nonc sous sa rubrique Domainedapplication, il est important de retenir quil incombe lutilisateur de juger si la normeconvient ses besoins particuliers.MCUne marque de commerce de lAssociation canadienne de normalisation,qui exerce ses activits sous le nom Groupe CSA. National Standard of Cana

42、daPublished in July 2012 by CSA GroupA 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 shop.csa.caPrepared byInternational Electrotechnical CommissionApproved byStandards Council of Canad

43、aCAN/CSA-C22.2 No. 60601-2-25:12Medical electrical equipment Part2-25: Particular requirements for the basic safety and essential performance of electrocardiographsReviewed byTMA trade-mark of the Canadian Standards Association, operating as “CSA Group”CAN/CSA-C22.2 No. 60601-2-25:12Medical electric

44、al equipment Part 2-25: Particularrequirements for the basic safety and essentialperformance of electrocardiographsCSA/8 2012 CSA Group July 2012CAN/CSA-C22.2 No. 60601-2-25:12Medical electrical equipment Part2-25: Particular requirements for the basic safety and essential performance of electrocard

45、iographsCSA PrefaceThis is the second edition of CAN/CSA-C22.2 No. 60601-2-25, Medical electrical equipment Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs, which is an adoption, with Canadian deviations, of the identically titled IEC (Interna

46、tional Electrotechnical Commission) Standard 60601-2-25 (second edition, 2011-10). It supersedes the previous edition, published in 1994 as CAN/CSA-C22.2 No. 601.2.25 under the title Medical electrical equipment Part 2: Particular requirements for the safety of electrocardiographs (adopted IEC 601-2

47、-25:1993). It also replaces CAN/CSA-C22.2 No. 60601-2-51, published in 2004 under the title Medical electrical equipment Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (adopted IEC 60601-2

48、-51:2003; replaced by IEC bilingual edition, 2005). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.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

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