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CAN CSA-CEI IEC 62304-2014 Medical device software - Software life cycle processes (First Edition).pdf

1、CAN/CSA-CEI/IEC 62304:14Medical device software Software life cycle processes(CEI/IEC 62304:2006, IDT)CAN/CSA-CEI/IEC 62304:14Logiciels de dispositifs mdicaux Processus du cycle de vie du logiciel(CEI/IEC 62304:2006, IDT)CAN/CSA-CEI/IEC 62304:14(CEI/IEC 62304:2006, IDT)National Standard of CanadaNor

2、me nationale du Canada IEC 2006. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited. CEI 2006. Groupe CSA 2014. Tous droits rservs. Toute reproduction sans autorisation est strictement interdite.Standards Update ServiceCAN/CSA-CEI/IEC 62304:14January 2014Title: Med

3、ical device software Software life cycle processesPagination: 166 pages (CSA/1CSA/11 and 155 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 2422975

4、.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 jour des normesCAN/CSA-CEI/IEC 62304:14Janvier 2014Titre : Logiciels de dispositifs mdi

5、caux Processus du cycle de vie du logicielNombre de pages : 166 pages (CSA/1 CSA/11 et 155 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 Service de mises jourLe numro didentification

6、dont vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 2422975.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/

7、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 the Standards Council of Canada. This process brings together vo

8、lunteers 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 test, evaluate, or verify the content of standards.Disclaimer and

9、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 a particular purpose or use, its merchantability, or its non-i

10、nfringement 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 regarding this documents compliance with any applicable statute, rul

11、e, 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 EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECI

12、AL 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 RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT

13、, 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 behalf of any person or entity or to perform any duty owed by an

14、y 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 in any way from any and all use of or reliance on the informat

15、ion 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 standards or other documents it publishes. Intellectual property right

16、s 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 trade-marks (except as otherwise noted to the contrary), and all in

17、ventions 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, or disclosure of this document may violate laws that protect CSA

18、 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 reserves all intellectual property rights in this document.Patent righ

19、tsAttention 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 expressly advised that determination of the validity of any such p

20、atent 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:If this document is in electronic form:sLOADTHISDOCUMENTONTOAC

21、OMPUTERFORTHESOLEPURPOSEOFREVIEWINGITsSEARCHANDBROWSETHISDOCUMENTANDsPRINTTHISDOCUMENTIFITISIN0$consulter et parcourir ce document ;imprimer ce document si cest une version PDF.modifier ce document de quelque faon que ce soit ou retirer le prsent avis juridique joint ce document ;vendre ce document

22、sans lautorisation du Groupe CSA ;fCanadian Standards Association (operatingas “CSA Group”), 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, nonsta

23、tutory, voluntary membership association engaged in standards development and certification activities. CSA Group standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standar

24、ds are used widely by industry and commerce 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 su

25、pport for CSA Groups standards development by volunteering their time and skills to Committee work and supporting CSA Groups objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSA Groups total membership from which its

26、 Directors are chosen. Sustaining memberships represent a major source of income for CSA Groups standards development activities. CSA Group offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certificatio

27、n process, CSA Group regularly and continually audits and inspects products that bear the CSA Group Mark. In addition to its head office and laboratory complex in Toronto, CSA Group has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Sin

28、ce 1919, CSA Group has developed the necessary expertise to meet its corporate mission: CSA Group 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

29、and related services to meet national and international needs.For further information on CSA Group services, write toCSA Group5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is the coordinating body of the Canadian standardization network, which i

30、s composed of people and organizations involved in the development, promotion and implementation of standards. Through the collaborative efforts of Canadian standardization network members, standardization is helping to advance the social and economic well-being of Canada and to safeguard the health

31、 and safety of Canadians. The networks efforts are overseen by SCC. The principal objectives of SCC are to foster and promote voluntary standardization as a means of advancing the national economy, supporting sustainable development, benefiting the health, safety and welfare of workers and the publi

32、c, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation in relation to standardization. An important facet of the Canadian standards development system is the use of the following principles: consensus; equal access and effect

33、ive participation by concerned interests; respect for diverse interests and identification of those who should be afforded access to provide the needed balance of interests; mechanism for dispute resolution; openness and transparency; open access by interested parties to the procedures guiding the s

34、tandards development process; clarity with respect to the processes; and Canadian interest consideration as the initial basis for the development of standards. A National Standard of Canada (NSC) is a standard prepared or reviewed by an SCC-accredited SDO and approved by the SCC according to NSC app

35、roval requirements. Approval does not refer to the technical content of the standard, as this remains the 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 g

36、eneral interests, producers, regulators, users (including consumers) and others with relevant interests, as may be appropriate to the subject at hand. NSCs are intended to make a significant and timely contribution to the Canadian interest. Those who have a need to apply standards are encouraged to

37、use NSCs. These standards are subject to periodic review. Users of NSCs are cautioned to obtain the latest edition from the SDO that publishes the standard. The responsibility for approving standards as NSCs rests withStandards Council of Canada 270 Albert Street, Suite 200 Ottawa, Ontario, K1P 6N7C

38、anadaAlthough 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 Association, operating as “CSA Group”Cette Nor

39、me Nationale du Canada est disponible en versions franaise et anglaise.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

40、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 llaborationde normes et la certification. Les normes du Groupe CSA refltent le consensus de producteurs et dusagers de partout au pay

41、s, au nombredesquels se trouvent des 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

42、, 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 Canadiens dun bout lautre du pays tmoignent de leur appui au travail de normalisation men par leGroupe CSA en participant bn

43、volement 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 les 2000 membres de soutien constituent lensemble des membres du Groupe CSA parmi lesquels ses administrateurssont choisis.

44、 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 certification et demise lessai qui appuient et compltent ses activits dans ledomaine de llaboration de normes. De manire ass

45、urer 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 sige social et ses laboratoires Toronto, le Groupe CSA possde des bureaux rgionaux dans descentres vitaux partout au Canada

46、, 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 dentreprise, savoir le Groupe CSA est un organisme de services indpendantdont la mission est doffrir une tribune libre et efficace

47、 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 clients, tant lchelle nationale quinternationale.Pour plus de renseignements sur les services du Groupe CSA, sadresser a

48、uGroupe CSA5060, Spectrum Way, bureau 100Mississauga (Ontario) L4W 5N6CanadaLe Conseil canadien des normes (CCN) est le coordonnateur du rseau canadien de normalisation, lequel est compos de personnes et dorganismes qui participent llaboration, la promotion et la mise en uvre des normes. Grce aux efforts conjugus des membres du rseau canadien de normalisation, les travaux de normalisation contribuent amliorer le bien-tre collectif et conomique du Canada et protger la sant et la scurit des Canadiens. Le CCN veille au bon droul

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