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CAN CSA-ISO 11195-2014 Gas mixers for medical use - Stand-alone gas mixers (First Edition).pdf

1、 ISO 1995. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 11195:14(ISO 11195:1995, IDT)National Standard of CanadaCAN/CSA-ISO 11195:14Gas mixers for medicaluse Stand-alonegas mixers(ISO 11195:1995, IDT)LegalNotice for StandardsCanadian Standards Ass

2、ociation (operating as “CSA Group”) develops standards through a consensus standards development process approvedby the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensusand develop a standard. Although CSA Group adm

3、inisters the process and establishes rules to promote fairness in achieving consensus,it doesnot independently test, evaluate, or verify the content of standards.Disclaimerand exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express

4、or implied, including, without limitation,implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringementof any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or curren

5、cy of any of the informationpublished in this document. CSA Group makes no representations or warranties regarding this documents compliancewith any applicablestatute, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES,

6、 DIRECTORS, OROFFICERS, 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 OTHER COMMERCIAL OR ECONOMIC LOSS,WHETHE

7、R BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OFLIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA GROUP HAS BEENADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this do

8、cument available, CSA Group 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 or entity. The information in this document is directedto those who have the appropriate degree of exp

9、erience to use and apply its contents, and CSA Group accepts no responsibility whatsoeverarising 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 Gr

10、oup has no power, nor does itundertake, to enforce compliancewith the contents of the standards or other documents it publishes.Intellectualpropertyrights 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 au

11、thorizedlicensee,of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and allinventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patentsand applic

12、ations for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate lawsthat 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 forsuch use, modification, cop

13、ying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights inthis 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 heldrespons

14、ible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any suchpatent rights is entirely their own responsibility.Authorizeduse of this documentThis document is being provided by CSA Group for informational and non-comme

15、rcial 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 if it is in PDF format.Limited copies of this docu

16、ment in print or paper form may be distributed only to persons who are authorized by CSA Group 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 this Legal Notice from the attac

17、hed standard; sell this document without authorization from CSA Group; 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 anycopies of the contents hereof, and if you do ma

18、ke such copies, you are required to destroy them immediately. Use of this document constitutesyour acceptanceof the terms and conditions of this Legal Notice.Standards UpdateServiceCAN/CSA-ISO 11195:14October 2014Title: Gas mixers for medical use Stand-alone gas mixersTo register for e-mail notifica

19、tion about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2423513.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at cs

20、agroup.org/legalto find out how we protect your personalinformation.CanadianStandards Association (operating as “CSA Group”), underwhose auspicesthis National Standard has been produced, waschartered in 1919 and accredited by the Standards Council of Canadato the National Standards system in 1973. I

21、t is a not-for-profit,nonstatutory, voluntary membership association engaged instandards development and certification activities.CSA Group standards reflect a national consensus of producers andusers including manufacturers, consumers, retailers, unions andprofessional organizations, and government

22、al agencies. Thestandards are used widely by industry and commerce and oftenadopted by municipal, provincial, and federal governments in theirregulations, particularlyin the fields of health, safety, building andconstruction, and the environment.Individuals, companies, and associationsacross Canada

23、indicate theirsupport for CSA Groups standards development by volunteeringtheir time and skills to Committee work and supporting CSA Groupsobjectivesthrough sustaining memberships. The more than 7000committee volunteers and the 2000 sustaining membershipstogether form CSA Groups total membership fro

24、m which itsDirectors are chosen. Sustaining memberships represent a majorsource of income for CSA Groups standards development activities.CSA Group offers certification and testing servicesin support of andas an extension to its standards development activities. To ensurethe integrity of its certifi

25、cation process, CSA Group regularly andcontinually audits and inspects products that bear theCSA Group Mark.In addition to its head office and laboratory complex in Toronto, CSAGroup has regional branch offices in major centres across Canadaand inspection and testing agencies in eight countries. Sin

26、ce 1919,CSA Group has developed the necessaryexpertise to meet itscorporate mission: CSA Group is an independent service organizationwhose mission is to provide an open and effective forum foractivities facilitating the exchange of goods and servicesthrough theuse of standards, certification and rel

27、ated servicesto meet nationaland international needs.For further information on CSA Group services,write toCSA Group5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Councilof Canada (SCC) is the coordinating body ofthe Canadian standardization network, which is composed o

28、f peopleand organizations involved in the development, promotion andimplementation of standards. Through the collaborative efforts ofCanadian standardization network members, standardization ishelping to advance the social and economic well-being of Canada andto safeguard the health and safety of Ca

29、nadians.The networksefforts are overseen by SCC.The principal objectives of SCC are to foster and promote voluntarystandardization as a means of advancing the national economy,supporting sustainable development, benefiting the health, safetyand welfare of workers and the public, assisting and protec

30、ting theconsumer, facilitating domestic and international trade, andfurthering international cooperation in relation to standardization.An important facet of the Canadian standards development system isthe use of the following principles: consensus; equal access andeffective participation by concern

31、ed interests; respect for diverseinterests and identification of those who should be afforded accessto provide the needed balance of interests; mechanismfor disputeresolution; openness and transparency; open access by interestedparties to the procedures guiding the standards developmentprocess; clar

32、ity with respect to the processes; and Canadian interestconsideration as the initial basis for the development of standards.A National Standard of Canada (NSC) is a standard prepared orreviewed by an SCC-accredited SDO and approved by the SCCaccording to NSC approval requirements. Approval does not

33、refer tothe technical content of the standard, as this remains theresponsibility of the SDO. An NSC reflects a consensus of a number ofcapable individuals whose collective interests provide, to the greatestpracticable extent, a balance of representation of general interests,producers, regulators, us

34、ers (including consumers) and others withrelevant interests, as may be appropriate to the subject at hand.NSCs are intended to make a significant and timely contribution tothe Canadian interest.Those who have a need to apply standards are encouraged to useNSCs. These standards are subjectto periodic

35、 review. Users of NSCsare cautioned to obtain the latest edition from the SDO thatpublishes the standard.The responsibility for approving standards as NSCs rests withStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme Nationale du Canada nest disponible q

36、uen anglais. Le Groupe CSA publiera la version en franais ds quelle sera produite parlorganisme rdacteur.Although the intended primaryapplication of this Standard is stated in its Scope, it is important to note that it remainsthe responsibility of theusers to judge its suitability for their particul

37、ar purpose.TMA trade-mark of the Canadian Standards Association,operating as “CSA Group”ICS 11.040.10ISBN 978-1-77139-847-3 2014 CSA GroupAll rights reserved.No part of this publication may be reproduced in any form whatsoever withoutthe prior permission of the publisher.Published in October 2014 by

38、 CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6To purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Ass

39、ociation,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byGas mixers for medical use Stand-alone gas mixers(ISO 11195:1995,IDT)CAN/CSA-ISO 11195:14National Standard of CanadaCAN/CSA-ISO 11195:14 Gas mixers for medical use Stand-alone gas mixersOc

40、tober 2014 2014 CSA GroupCSA/5CAN/CSA-ISO 11195:14Gas mixers for medical use Stand-alonegas mixers(ISO 11195:1995,IDT)CSA PrefaceThis is the first edition of CAN/CSA-ISO 11195, Gas mixers for medical use Stand-alone gas mixers,which is an adoption without modification of the identically titled ISO (

41、International Organization forStandardization) Standard 11195 (first edition, 1995-10-01).At the time of publication, ISO 11195:1995isavailable from ISO in English only. CSA Group will publish the French version when it becomes availablefrom ISO.For brevity, this Standard will be referred to as “CAN

42、/CSA-ISO 11195” throughout.This Standard was reviewed for Canadian adoption by the Standards Mirror Committee to ISO/TC 121,under the jurisdiction of the CSA Technical Committee on Perioperative Safety and the CSA StrategicSteering Committee on Health Care Technology and Systems, and has been formal

43、ly approved by theTechnical Committee. This Standard has been approved as a National Standard of Canada by theStandards Council of Canada. 2014 CSA GroupAll rights reserved.No part of this publication may be reproducedin any form whatsoeverwithout theprior permission of the publisher. ISO material i

44、s reprinted with permission. Where the words “thisInternational Standard” appear in the text, they should be interpreted as “this National Standard ofCanada”.Inquiries regarding this National Standard of Canada should be addressedtoCSA Group5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada,

45、 L4W 5N61-800-463-6727 416-747-4000http:/csa.caTo purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free1-800-463-6727or 416-747-4044.This Standard is subject to review five years from the date of publication, and suggestions for itsimprovementwill be ref

46、erred to the appropriate committee. To submit a proposal for change, please sendthe following information to inquiriescsagroup.organd include“Proposal for change” in the subjectline:a) Standard designation (number);b) relevant clause,table, and/or figure number;c) wording of the proposed change; and

47、d) rationale for the change.CSA Technical Committeeon PerioperativeSafetyR. Khotar Providence Health Care,Vancouver, British ColumbiaCategory: User ManagementChairB.W. McLeod Maple Ridge, British ColumbiaCategory: Health Care ProfessionalVice-ChairM. Armutlu Jewish General Hospital,Montral, QubecCat

48、egory: User ManagementA. Bialachowski St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementD.A. Chartrand Montreal Neurological Hospital,Montral, QubecCategory: Health Care ProfessionalJ.D.Y. Deslauriers Consultant,Gatineau, QubecCategory: Governmentand/or Regulatory AuthorityN.

49、 Dolan Drger Medical Canada Inc.,Mississauga, OntarioCategory: Producer InterestB. Hunt Class 1 Inc.,Cambridge, OntarioCategory: Producer InterestC. Landers Weeneebayko General Hospital,Moose Factory, OntarioCategory: General InterestJ.Y. Latreille Clarion Medical Technologies Inc.,Montral, QubecAssociateK.L. LeDez Memorial University of Newfoundland,St. Johns, Newfoundland and LabradorCategory: Health Care ProfessionalG. Mendes GE Healthcare Technologies,Mississauga, OntarioCategory: Producer InterestP.I. Mendes 3M Canada,London, On

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