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CAN CSA-ISO 5360-2014 Anaesthetic vaporizers - Agent-specific filling systems (First Edition).pdf

1、 ISO 2012. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 5360:14(ISO 5360:2012, IDT)National Standard of CanadaCAN/CSA-ISO 5360:14Anaestheticvaporizers Agent-specificfillingsystems(ISO 5360:2012, IDT)LegalNotice for StandardsCanadian Standards Asso

2、ciation (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 admi

3、nisters 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 o

4、r 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 currenc

5、y 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,WHETHER

7、 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 doc

8、ument 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 expe

9、rience 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 Gro

10、up 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 aut

11、horizedlicensee,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 applica

12、tions 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, copy

13、ing, 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 heldresponsi

14、ble 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-commer

15、cial 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 docum

16、ent 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 attach

17、ed 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 mak

18、e 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 5360:14February 2014Title: Anaesthetic vaporizers Agent-specific filling systemsTo register for e-mail notif

19、ication 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 2422942.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at

20、 csagroup.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

21、. It 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 governm

22、ental 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 Cana

23、da 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

24、from 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 cert

25、ification 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.

26、Since 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

27、related 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 compose

28、d of 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

29、 Canadians.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 pro

30、tecting 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 conc

31、erned 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; c

32、larity 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 n

33、ot 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,

34、 users (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 perio

35、dic 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 est disponible

36、 en versions franaise et anglaise.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 particular purpose.TMA trade-mark of the Canadian Standards Association,operati

37、ng as “CSA Group”ICS 11.040.10ISBN 978-1-77139-521-2 2014 CSA GroupAll rights reserved.No part of this publication may be reproduced to any form whatsoever withoutthe prior permission of the publisher.Published in February 2014 by CSA GroupA not-for-profit private sector organization5060 Spectrum Wa

38、y, 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 Association,operating as “CSA Group”Reviewed byPrepared byInternational O

39、rganization for StandardizationApproved byAnaestheticvaporizers Agent-specific filling systems(ISO 5360:2012,IDT)CAN/CSA-ISO 5360:14National Standard of CanadaCAN/CSA-ISO 5360:14 Anaesthetic vaporizers Agent-specific filling systemsFebruary 2014 2014 CSA GroupCSA/5CAN/CSA-ISO 5360:14Anaestheticvapor

40、izers Agent-specificfilling systems(ISO 5360:2012,IDT)CSA PrefaceThis is the first edition of CAN/CSA-ISO 5360, Anaesthetic vaporizers Agent-specific filling systems,which is an adoption without modification of the identically titled ISO (International Organization forStandardization) Standard 5360

41、(third edition, 2012-01-15).It replaces the previous edition published in2008 as CAN/CSA-Z5360 (adopted ISO 5360:2006).For brevity, this Standard will be referred to as“CAN/CSA-ISO 5360” throughout.With regards to the caution statement in Clause 14.2.2,the French equivalent is “Attention : lopration

42、de remplissage spcifique lagent ne peut tre assure avec des flacons sans anneaux”.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

43、Health Care Technology b) relevant clause,table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.CSA Technical Committeeon PerioperativeSafetyS. Taylor London, OntarioCategory: General InterestChairM. Armutlu Jewish General Hospital,Montral, QubecCategory: User

44、 ManagementA. Bialachowski St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementD.A. Chartrand Montreal Neurological Hospital,Montral, QubecCategory: Health Care ProfessionalJ.D. Deslauriers Health Canada,Ottawa, OntarioCategory: Governmentand/or Regulatory AuthorityN. Dolan Drg

45、er Medical Canada Inc.,Richmond Hill, OntarioAssociateB. Hunt Class 1 Inc.,Cambridge, OntarioCategory: Producer InterestR. Khotar Providence Health Care,Vancouver, British ColumbiaCategory: User ManagementC. Landers Weeneebayko General Hospital,Moose Factory, OntarioCategory: General InterestJ.Y. La

46、treille Clarion Medical Technologies Inc.,Montral, QubecAssociateK.L. LeDez Memorial University of Newfoundland,St. Johns, Newfoundland and LabradorCategory: Health Care ProfessionalB.W. McLeod Maple Ridge, British ColumbiaCategory: Health Care ProfessionalG. Mendes GE Healthcare Technologies,Missis

47、sauga, OntarioCategory: Producer InterestP.I. Mendes 3M Canada,London, OntarioAssociateD.H. Piper MAQUET-DYNAMED Inc.,Markham,OntarioCategory: Producer InterestM. Sagar WorkSafe BC,Vancouver, British ColumbiaCategory: Governmentand/or Regulatory AuthorityR.C. Shantz Parkin Architects Limited,Toronto

48、, OntarioCategory: General InterestP.J. Smalley Technology Concepts International,Chicago, Illinois, USACategory: General InterestC. Stark London Health Sciences Centre,London, OntarioAssociateH. Thiemann Medical Device Industry Consultant,Perkasie, Pennsylvania, USACategory: Producer InterestK.L. W

49、arcimaga Selkirk and District General Hospital,Selkirk, ManitobaCategory: User ManagementJ. Wilding Drger Medical Canada Inc.,Richmond Hill, OntarioCategory: Producer InterestC. Cortissoz CSA Group,Mississauga, OntarioProject ManagerReference numberISO 5360:2012(E)ISO 2012INTERNATIONAL STANDARD ISO5360Third edition2012-01-15Anaesthetic vaporizers Agent-specific filling systems vaporateurs danesthsie Systmes de remplissage spcifiques lagent ISO 5360:2012(E) COPYRIGHT PROTECTED DOCUMENT ISO 2012 All rights reserved. Unless o

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