CAN CSA-C22 2 NO 60601-2-13-2007 Medical electrical equipment – Part 2-13 Particular requirements for the safety and essential performance of anaesthetic systems (Third Edition).pdf

1、Medical electrical equipment Part 2-13:Particular requirements for the safety andessential performance of anaesthetic systemsAppareils lectromdicaux Partie 2-13:Rgles particulires de scurit etperformance essentielle pour les systmes danesthsieReference numberIEC 60601-2-13:2003(E) International Elec

2、trotechnical Commission (IEC), 2003. All rights reserved. NOT FOR RESALE. National Standard of CanadaCAN/CSA-C22.2 No. 60601-2-13:06(IEC 60601-2-13:2003)International Standard IEC 60601-2-13:2003 (third edition, 2003-05), including Amendment 1:2006, hasbeen adopted with Canadian deviations (MOD) as

3、CSA Standard CAN/CSA-C22.2 No. 60601-2-13:06, whichhas been approved as a National Standard of Canada by the Standards Council of Canada.ISBN 1-55436-323-3 December 2006National Standard of CanadaCAN/CSA-C22.2 No. 60601-2-13:07International Standard IEC 60601-2-13:2003 (third edition, 2003-05), incl

4、uding Amendment 1:2006, hasbeen adopted with Canadian deviations (MOD) as CSA Standard CAN/CSA-C22.2 No. 60601-2-13:07, whichhas been approved as a National Standard of Canada by the Standards Council of Canada.ISBN 1-55436-323-3 March 2007Publication numberingAs from 1 January 1997 all IEC publicat

5、ions are issued with a designation in the60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.Consolidated editionsThe IEC is now publishing consolidated versions of its publications. For example,edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, thebase

6、publication incorporating amendment 1 and the base publication incorporatingamendments 1 and 2.Further information on IEC publicationsThe technical content of IEC publications is kept under constant review by the IEC,thus ensuring that the content reflects current technology. Information relating to

7、this publication, including its validity, is available in the IEC Catalogue ofpublications (see below) in addition to new editions, amendments and corrigenda.Information on the subjects under consideration and work in progress undertakenby the technical committee which has prepared this publication,

8、 as well as the listof publications issued, is also available from the following: IEC Web Site (www.iec.ch) Catalogue of IEC publicationsThe on-line catalogue on the IEC web site (http:/www.iec.ch/searchpub/cur_fut.htm)enables you to search by a variety of criteria including text searches, technical

9、committees and date of publication. On-line information is also available onrecently issued publications, withdrawn and replaced publications, as well ascorrigenda. IEC Just Published This summary of recently issued publications (http:/www.iec.ch/online_news/justpub/jp_entry.htm) is also available b

10、y email. Please contact the CustomerService Centre (see below) for further information. Customer Service CentreIf you have any questions regarding this publication or need further assistance,please contact the Customer Service Centre:Email: custserviec.chTel: +41 22 919 02 11Fax: +41 22 919 03 00CSA

11、 Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-13:07March 2007Title: Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsPagination: 57 pages (CSA/1CSA/10 and 47 text)To register for e-mail notification about any updates

12、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 2418142.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs p

13、olicy on privacy at csagroup.org/legal to find out how we protect your personal information.Blank pageLegal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by theStandards Council of Canada. This process brin

14、gs together volunteers representing varied viewpoints and interests to achieve consensusand develop a standard. Although CSA administers the process and establishes rules to promote fairness in achieving consensus, it doesnot independently test, evaluate, or verify the content of standards.Disclaime

15、r and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, withoutlimitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or itsn

16、on-infringement of any third partys intellectual property rights. CSA does not warrant the accuracy, completeness, or currency of anyof the information published in this document. CSA makes no representations or warranties regarding this documents compliance withany applicable statute, rule, or regu

17、lation.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 EXPENSES,HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL

18、 DAMAGES, LOST REVENUE, BUSINESSINTERRUPTION, 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 ORPOSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN

19、 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 anyperson or entity or to perform any duty owed by any person or entity to another person

20、 or entity. The information in this document isdirected to those who have the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibilitywhatsoever arising in any way from any and all use of or reliance on the information contained in this document.CSA is a priv

21、ate not-for-profit company that publishes voluntary standards and related documents. CSA has no power, nor does itundertake, 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 documen

22、t (whether it be in printed or electronic form), CSA is the owner, or the authorizedlicensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), andall inventions and trade secrets that may be contained in this document, whethe

23、r or not such inventions and trade secrets are protectedby patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this documentmay violate laws that protect CSAs and/or others intellectual property and may give rise to a right in CSA a

24、nd/or others to seek legalredress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectualproperty rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the s

25、ubject of patent rights. CSA shall not be heldresponsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity ofany such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being

26、 provided by CSA for informational and non-commercial use only. The user of this document is authorized to doonly 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.Li

27、mited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA to have suchcopies, 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 this Legal No

28、tice 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 ormake any copies of the contents hereof, and

29、 if you do make such copies, you are required to destroy them immediately. Use of thisdocument constitutes your acceptance of the terms and conditions of this Legal Notice.The Canadian Standards Association (CSA),under whose auspices this National Standard hasbeen produced, was chartered in 1919 and

30、accredited by the Standards Council of Canadato the National Standards system in 1973. It is anot-for-profit, nonstatutory, voluntary membershipassociation engaged in standards development andcertification activities.CSA standards reflect a national consensus ofproducers and users including manufact

31、urers,consumers, retailers, unions and professionalorganizations, and governmental agencies. Thestandards are used widely by industry and commerceand often adopted by municipal, provincial, andfederal governments in their regulations, particularlyin the fields of health, safety, building andconstruc

32、tion, and the environment.Individuals, companies, and associations acrossCanada indicate their support for CSAs standardsdevelopment by volunteering their time and skillsto CSA Committee work and supporting theAssociations objectives through sustainingmemberships. The more than 7000 committeevolunte

33、ers and the 2000 sustaining membershipstogether form CSAs total membership from whichits Directors are chosen. Sustaining membershipsrepresent a major source of income for CSAsstandards development activities.The Association offers certification and testingservices in support of and as an extension

34、to itsstandards development activities. To ensure theintegrity of its certification process, the Associationregularly and continually audits and inspects productsthat bear the CSA Mark.In addition to its head office and laboratorycomplex in Toronto, CSA has regional branch officesin major centres ac

35、ross Canada and inspection andtesting agencies in eight countries. Since 1919, theAssociation has developed the necessary expertise tomeet its corporate mission: CSA is an independentservice organization whose mission is to provide anopen and effective forum for activities facilitating theexchange o

36、f goods and services through the use ofstandards, certification and related services to meetnational and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (

37、SCC) is thecoordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations working towards the furtherdevelopment and improvement of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary standardiz

38、ation as a meansof advancing the national economy, benefiting thehealth, safety, and welfare of the public, assistingand protecting the consumer, facilitating domesticand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a s

39、tandardprepared or reviewed by an accredited StandardsDevelopment Organization (SDO) and approvedby the SCC according to the requirements of CAN-P-2.Approval does not refer to the technical content of thestandard; this remains the continuing responsibility ofthe SDO. An NSC reflects a consensus of a

40、 number ofcapable individuals whose collective interests provide,to the greatest practicable extent, a balance ofrepresentation of general interests, producers,regulators, users (including consumers), and otherswith relevant interests, as may be appropriate to thesubject in hand. It normally is a st

41、andard which iscapable of making a significant and timely contributionto 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 whichpublishes the st

42、andard.The responsibility for approving standards asNational Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is importantto note that it remain

43、s the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationCette norme est offerte en anglais seulement pour le moment. La CSA publiera la version enfranais ds quelle sera produite par lorganisme rdacteur.Approved by

44、Standards Council of CanadaNational Standard of CanadaPublished in March 2007 by Canadian Standards AssociationA 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 www.ShopCSA.caCAN/CSA-C22.

45、2 No. 60601-2-13:07Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsPrepared by International Electrotechnical CommissionReviewed byCAN/CSA-C22.2 No. 60601-2-13:07Medical electrical equipment Part 2-13: Particular requirem

46、entsfor the safety and essential performance of anaesthetic systemsCSA/4 Canadian Standards Association March 2007CAN/CSA-C22.2 No. 60601-2-13:07Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsCSA PrefaceThis is the third

47、 edition of CAN/CSA-C22.2 No. 60601-2-13, Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standar

48、d 60601-2-13 (third edition, 2003-05), including Amendment 1:2006. It supersedes the previous edition published in 2002 as CAN/CSA-C22.2 No. 60601-2-13, Medical electrical equipment Part 2-13: Particular requirements for the safety of anaesthetic workstations (adopted IEC 60601-2-13:1998). At the ti

49、me of publication, IEC 60601-2-13:2003 and Amendment 1:2006 are available from IEC in English only. CSA will publish the French versions when they become available from IEC.This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Anaesthetic Equipment, under the jurisdiction of the CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Comm