CAN CSA-C22 2 NO 60601-2-34-2012 Medical electrical equipment - Part 2-34 Particular requirements for the basic safety and essential performance of invasive blood pressure monitori.pdf

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1、Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipmentAppareils lectromdicaux Partie 2-34 : Exigences particulires pour la scurit de base et les performances essentielles des appareils de surveill

2、ance de la pression sanguine prleve directementCAN/CSA-C22.2 No. 60601-2-34:12(IEC 60601-2-34:2011, MOD)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-34:12June 2012Title: Medical electrical equi

3、pment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipmentPagination: 148 pages (CSA/1CSA/14 and 134 text)To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update Service

4、The List ID that you will need to register for updates to this publication is 2421822.If you require 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 jo

5、ur des normesCAN/CSA-C22.2 n 60601-2-34:12Juin 2012Titre : Appareils lectromdicaux Partie 2-34 : Exigences particulires pour la scurit de base et les performances essentielles des appareils de surveillance de la pression sanguine prleve directementNombre de pages : 148 pages (CSA/1 CSA/14 et 134 pag

6、es 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 Service de mises jourLe numro didentification dont vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 24218

7、22.Si vous avez besoin daide, veuillez nous contacter par courriel au techsupportcsagroup.org ou par tlphone au 416-747-2233.Consultez la politique du Groupe CSA en matire de confidentialit au csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.Legal Notice for Standa

8、rdsCanadian Standards Association (operating as “CSA Group”) develops standards through 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 stand

9、ard. Although CSA Group 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 document is provided without any representations, warranties, or co

10、nditions 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 intellectual property rights. CSA Group does not warrant the a

11、ccuracy, completeness, or currency of any of the information published in this document. CSA Group makes no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFIL

12、IATED 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, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY

13、 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 GROUP HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS,

14、OR EXPENSES.In publishing and making this document available, CSA Group 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 information in this document is directed t

15、o those who have the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoever arising 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 v

16、oluntary standards and related documents. CSA Group 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 Group and the users of this document (whether it be in printed o

17、r electronic form), CSA Group 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 inventi

18、ons 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 CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/or o

19、thers to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group 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

20、subject of patent rights. CSA Group 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

21、 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:If this document is in electronic form:sLOADTHISDOCUMENTONTOACOMPUTERFORTHESOLEPURPOSEOFREVIEWINGITsSEARCHANDBROWSETHISDOCUMENTANDsPRINTTHISDOCUMENTIFITISIN

22、0$ this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of capable individuals whose collective interests provide, to the greatest practicable extent, a balance of representation of general interests, producers, regulators, users (including consumers), and o

23、thers with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant and timely contribution to the national interest.Those who have a need to apply standards areencouraged to use NSCs. These standards are subjectto periodic

24、review. Users of NSCs are cautionedto obtain the latest edition from the SDO which publishes the standard.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme national

25、e du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards As

26、sociation, operating as “CSA Group”exerce ses activits sous le nom Groupe CSA),sous les auspices de laquelle cette Norme nationale a LAssociation 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 can

27、adien des normes en 1973. Association daffiliation libre, sans but lucratif ni pouvoir de rglementation, le Groupe CSA se consacre llaborationde 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

28、 fabricants, des consommateurs, des dtaillants et des reprsentants de syndicats, de corps professionnels et dagences gouvernementales. Lutilisation des normes du Groupe CSA est trs rpandue dans lindustrie et le commerce, et leur adoption diversordres de lgislation, tant municipal et provincial quefd

29、ral, est chose courante, particulirement dans lesdomaines de la sant, de la scurit, du btiment, de laconstruction et de lenvironnement. Les Canadiens dun bout lautre du pays tmoignent de leur appui au travail de normalisation men par leGroupe CSA en participant bnvolement aux travaux descomits du Gr

30、oupe CSA et en appuyant ses objectifs par leurs cotisations de membres de soutien. Les quelque 7000 volontaires faisant partie des comits et les 2000 membres de soutien constituent lensemble des membres du Groupe CSA parmi lesquels ses administrateurssont choisis. Les cotisations des membres de sout

31、ienreprsentent une source importante de revenu pour lesservices de soutien la normalisation volontaire. Le Groupe CSA offre des services de certification et demise lessai qui appuient et compltent ses activits dans ledomaine de llaboration de normes. De manire assurer lintgrit de son processus de ce

32、rtification, le Groupe CSA procde de faon rgulire et continue lexamen et linspection des produits portant la marque du Groupe CSA. Outre son sige social et ses laboratoires Toronto, le Groupe CSA possde des bureaux rgionaux dans descentres vitaux partout au Canada, de mme que des agences dinspection

33、 et dessai dans huit pays. Depuis 1919, le Groupe CSA a parfait les connaissances techniques qui lui permettent de remplir sa mission dentreprise, savoir le Groupe CSA est un organisme de services indpendantdont la mission est doffrir une tribune libre et efficace pourla ralisation dactivits facilit

34、ant lchange de biens et de services par lintermdiaire de services de normalisation, de certification et autres, pour rpondre aux besoins de nos clients, tant lchelle nationale quinternationale.Pour plus de renseignements sur les services du Groupe CSA, sadresser auGroupe CSA5060, Spectrum Way, burea

35、u 100Mississauga (Ontario) L4W 5N6CanadaLe Conseil canadien des normes (CCN) coordonne le Systme national de normes, une coalition dorganismes indpendants et autonomes qui se consacrent au dveloppement et lamlioration de la normalisation volontaire dans lintrt national.Les principaux buts du CCN son

36、t dencourager et de favoriser la normalisation volontaire en vue de dvelopper lconomie nationale, damliorer la sant, la scurit et le bien-tre du public, daider et de protger le consommateur, de faciliter le commerce intrieur et extrieur et de promouvoir la coopration internationale dans le domaine d

37、es normes.Une Norme nationale du Canada (NNC) est une norme prpare ou examine par un organisme dlaboration de normes (OEN) accrdit et approuve 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

38、lOEN. Toute NNC reflte un consensus raisonnable parmi les points de vue dun certain nombre de personnes comptentes dont les intrts runis forment, au degr le plus lev possible, une reprsentation quilibre des intrts des producteurs, des organismes de rglementation, des utilisateurs (y compris les cons

39、ommateurs) et dautres personnes intresses, selon le domaine envisag. Il sagit gnralement dune norme qui peut apporter une contribution apprciable, 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

40、lobjet dexamens priodiques; cest pourquoi lon recommande aux utilisateurs de se procurer ldition la plus rcente de la norme auprs de lorganisme qui la publie.La responsabilit dapprouver les normes en tant que Normes nationales du Canada incombe au :Conseil canadien des normes270, rue Albert, bureau

41、200Ottawa (Ontario) K1P 6N7CanadaThis National Standard of Canada is available in English and French.Bien que le but premier vis par cette norme soit nonc sous sa rubrique Domainedapplication, il est important de retenir quil incombe lutilisateur de juger si la normeconvient ses besoins particuliers

42、.MCUne marque de commerce de lAssociation canadienne de normalisation,qui exerce ses activits sous le nom Groupe CSA. National Standard of CanadaPublished in June 2012 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-

43、6727 416-747-4044Visit our Online Store at shop.csa.caPrepared byInternational Electrotechnical CommissionApproved byStandards Council of CanadaCAN/CSA-C22.2 No. 60601-2-34:12Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive bl

44、ood pressure monitoring equipmentReviewed byTMA trade-mark of the Canadian Standards Association, operating as “CSA Group”CAN/CSA-C22.2 No. 60601-2-34:12Medical electrical equipment Part 2-34: Particularrequirements for the basic safety and essential performanceof invasive blood pressure monitoring

45、equipmentCSA/8 2012 CSA Group June 2012CAN/CSA-C22.2 No. 60601-2-34:12Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipmentCSA PrefaceThis is the third edition of CAN/CSA-C22.2 No. 60601-2-34, Me

46、dical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-34

47、(third edition, 2011-05). It supersedes the previous edition, published in 2002 as CAN/CSA-C22.2 No. 60601-2-34 (adopted IEC 60601-2-34:2000; replaced by IEC bilingual edition in 2005). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.This Standard

48、 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 conformity assessment within the stated scope of the Standard.This Standard was reviewed for

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