CAN CSA-ISO 27427-2014 Anaesthetic and respiratory equipment - Nebulizing systems and components (First Edition).pdf

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1、 ISO 2013. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 27427:14(ISO 27427:2013, IDT)National Standard of CanadaCAN/CSA-ISO 27427:14Anaestheticand respiratory equipmentNebulizingsystems and components(ISO 27427:2013, IDT)LegalNotice for StandardsC

2、anadian Standards Association (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. A

3、lthough CSA Group administers 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

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

5、pleteness, or currency 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,

6、 OR THEIR EMPLOYEES, 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

7、ECONOMIC LOSS,WHETHER 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 publishin

8、g and making this document available, CSA Group is not undertaking to render professional or other servicesfor 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 approp

9、riate degree of experience 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 relate

10、d documents. CSA Group 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 t

11、he owner, or the authorizedlicensee,of all works contained herein that are protected by copyright, all trade-marks (except as otherwisenoted 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

12、 patentsand applications 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,

13、 modification, copying, 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

14、not be heldresponsible 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 informati

15、onal 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 if it is in PDF format.Limited c

16、opies of this document 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 Not

17、ice from the attached 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

18、, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutesyour acceptanceof the terms and conditions of this Legal Notice.StandardsUpdateServiceCAN/CSA-ISO 27427:14October 2014Title: Anaesthetic and respiratory equipment Nebulizing systems and co

19、mponentsTo register for e-mail notification 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 2423518.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.V

20、isit CSA Groups policy on privacy at 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 t

21、he National Standards system in 1973. 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 andpro

22、fessional organizations, and governmental 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, co

23、mpanies, and associationsacross Canada 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 membershipstogeth

24、er form CSA Groups total membership 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

25、. To ensurethe integrity of its certification 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 t

26、esting agencies in eight countries. 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 the

27、use of standards, certification and 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 stand

28、ardization network, which is composed 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

29、 safeguard the health and safety of 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

30、 and the public, assisting and protecting 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 a

31、ndeffective participation by concerned interests; respect for diverseinterests and identification of those who should be afforded accessto provide the needed balance of interests; mechanismfor disputeresolution; opennessand transparency;open access by interestedparties to the procedures guiding the

32、standards developmentprocess; clarity 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 approva

33、l requirements. Approval does not 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 i

34、nterests,producers, regulators, 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. Thes

35、e standards are subjectto periodic 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 Nat

36、ionale du Canada est disponible 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 Canadia

37、n Standards Association,operating as “CSA Group”ICS 11.040.10ISBN 978-1-77139-851-0 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 CSA GroupA not-for-profit private secto

38、r 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 Association,operating as “CSA Group”Reviewe

39、d byPrepared byInternational Organization for StandardizationApproved byAnaestheticand respiratoryequipmentNebulizing systems and components(ISO 27427:2013,IDT)CAN/CSA-ISO 27427:14National Standard of CanadaCAN/CSA-ISO 27427:14Anaesthetic and respiratory equipment Nebulizing systems and componentsOc

40、tober 2014 2014 CSA GroupCSA/5CAN/CSA-ISO 27427:14Anaestheticand respiratoryequipmentNebulizing systems and components(ISO 27427:2013,IDT)CSA PrefaceThis is the first edition of CAN/CSA-ISO 27427, Anaesthetic and respiratory equipment Nebulizingsystems and components, which is an adoption without mo

41、dification of the identically titled ISO(International Organization for Standardization) Standard 27427 (third edition, 2013-12-15).For brevity, this Standard will be referred to as “CAN/CSA-ISO 27427” throughout.This Standard was reviewed for Canadian adoption by the Standards Mirror Committee to I

42、SO/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 formally approved by theTechnical Committee. This Standard has been approved as a National Standard of Canada by theStan

43、dards 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 is reprinted with permission. Where the words “thisInternational Standard” appear in the text, they should be inter

44、preted as “this National Standard ofCanada”.Inquiries regarding this National Standard of Canada should be addressedtoCSA Group5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada, L4W 5N61-800-463-6727 416-747-4000http:/csa.caTo purchase standards and related publications, visit our Online St

45、ore 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 referred to the appropriate committee. To submit a proposal for change, please sendthe following information to inqui

46、riescsagroup.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; andd) rationale for the change.CSA Technical Committeeon PerioperativeSafetyR. Khotar Providence Health Care,Vancouve

47、r, British ColumbiaCategory: User ManagementChairB.W. McLeod Maple Ridge, British ColumbiaCategory: Health Care ProfessionalVice-ChairM. Armutlu Jewish General Hospital,Montral, QubecCategory: User ManagementA. Bialachowski St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementD.

48、A. Chartrand Montreal Neurological Hospital,Montral, QubecCategory: Health Care ProfessionalJ.D.Y. Deslauriers Consultant,Gatineau, QubecCategory: Governmentand/or Regulatory AuthorityN. Dolan Drger Medical Canada Inc.,Mississauga, OntarioCategory: Producer InterestB. Hunt Class 1 Inc.,Cambridge, On

49、tarioCategory: 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, OntarioAssociateD.R. Palmerton Buffalo Filter,Lancaster, New York, USAAssociateD.H. Piper MAQUET-DYNAMED Inc.,Markham,OntarioC

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