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CAN CSA-Z10651-4-2008 Lung ventilators - Part 4 Particular requirements for operator-powered resuscitators (First Edition).pdf

1、 Reference numberISO 10651-4:2002(E)ISO 2002INTERNATIONAL STANDARD ISO10651-4First edition2002-03-01Lung ventilators Part 4: Particular requirements for operator-powered resuscitators Ventilateurs pulmonaires Partie 4 : Exigences relatives aux ressuscitateurs puissance motrice manuelle National Stan

2、dard of CanadaCAN/CSA-Z10651-4-08International Standard ISO 10651-4:2002 (first edition, 2002-03-01) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z10651-4-08, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55436-666-8 F

3、ebruary 2008Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus

4、and develop a standard. Although CSA 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 exclusion of liabilityThis document is provided without any representations, warr

5、anties, 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-infringement of any third partys intellectual property rights. CSA does not warran

6、t the accuracy, completeness, or currency of any of the information published in this document. CSA makes no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED

7、 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 DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHE

8、R 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, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES

9、.In publishing and making this document available, CSA 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 any person or entity to another person or entity. The information in this document is directed to those who have

10、the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility whatsoever arising in any way from any and all use of or reliance on the information contained in this document. CSA is a private not-for-profit company that publishes voluntary standards and relate

11、d documents. CSA has no power, nor does it undertake, 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 document (whether it be in printed or electronic form), CSA is the owner, or

12、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 inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents

13、and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate laws that protect CSAs and/or others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for such use, modification, cop

14、ying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual property rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA shall not be held responsible for i

15、dentifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA for informational and non-commercial use only

16、. The user of this document is authorized to do only 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. Limited copies of this document in print or paper form may be

17、distributed only to persons who are authorized by CSA 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 attached standard;.sell this document without

18、 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 or make any copies of the contents hereof, and if you do make such copies, you are required to destroy t

19、hem immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.Standards Update ServiceCAN/CSA-Z10651-4-08February 2008Title: Lung ventilators Part 4: Particular requirements for operator-powered resuscitatorsPagination: 31 pages (CSA/1CSA/4, iv, a

20、nd 22 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 2418877.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.

21、Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the Nation

22、al Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional

23、organizations, and governmental agencies. The standards 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, compan

24、ies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and skills to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships

25、 together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSAs standards development activities. The Association offers certification and testing services in support of and as an extension to its standards development acti

26、vities. To ensure the integrity of its certification process, the Association regularly and continually audits and inspects products that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection

27、 and testing agencies in eight countries. Since 1919, the Association has developed the necessary expertise to meet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services

28、 through the use of standards, certification and related services to meet national and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is thecoordin

29、ating 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 standardization as a meansof

30、 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 standardprepared or

31、 reviewed by an accredited Standards Development Organization (SDO) and approved by the SCC according to the requirements of CAN-P-2. Approval does not refer to the technical content of the standard; this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of ca

32、pable individuals whose collective interests provide, to the greatest practicable extent, a balance of representation of general interests, producers, regulators, users (including consumers), and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard

33、which is capable of making a significant and timely contribution to 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 which publishes the standa

34、rd.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Stan

35、dard 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.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in February 2008

36、 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-Z10651-4-08Lung ventilators Part 4: Particular requirements for operator-powered

37、resuscitatorsRegistered trade-mark of Canadian Standards AssociationReviewed byPrepared byInternational Organization for StandardizationCAN/CSA-Z10651-4-08Lung ventilators Part 4: Particular requirementsfor operator-powered resuscitatorsFebruary 2008 Canadian Standards Association CSA/3CAN/CSA-Z1065

38、1-4-08Lung ventilators Part 4: Particular requirements for operator-powered resuscitatorsCSA PrefaceThis is the first edition of CAN/CSA-Z10651-4, Lung ventilators Part 4: Particular requirements for operator-powered resuscitators, which is an adoption, with Canadian deviations, of the identically t

39、itled ISO (International Organization for Standardization) Standard 10651-4 (first edition, 2002-03-01). This CSA Standard, and CAN/CSA-Z10651-5-08, Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators, replac

40、e CAN/CSA-Z8382-94, Resuscitators Intended for Use with Humans. 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 t

41、he Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.February 2008 Canadian Standards Association 2008All rights reserved. No part of t

42、his publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding th

43、is National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.csa.caTo purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free 1-

44、800-463-6727 or 416-747-4044.CAN/CSA-Z10651-4-08Lung ventilators Part 4: Particular requirementsfor operator-powered resuscitatorsCSA/4 Canadian Standards Association February 2008Canadian deviations2 Normative referencesReplace “prEN 13544-2:2000” with “EN 13544-2:2002” throughout this StandardAdd

45、the followingCSA (Canadian Standards Association)The requirements of the following National Standards of Canada, published by the Canadian Standards Association, shall take precedence over the equivalent Standards published by the European Committee for Standardization (CEN). Any reference in CAN/CS

46、A-Z10651-4 to the CEN Standards shall be replaced by a reference to the equivalent Canadian Standard.CAN/CSA-Z5356-1-08 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and socketsReplaces EN 1281-1CAN/CSA-Z9170-1-00 (R2005)Terminal units for medical gas pipeline systems Part 1

47、: Terminal units for use with compressed medical gases and vacuumReplaces EN 737-1ISO (International Organization for Standardization)The requirements of the following International Standards, published by the International Organization for Standardization, shall take precedence over the equivalent

48、Standards published by the European Committee for Standardization (CEN). Any reference in CAN/CSA-Z10651-4 to the CEN Standards shall be replaced by a reference to the equivalent ISO Standard.4135:2001 Anaesthetic and respiratory equipment VocabularyReplaces EN ISO 4135:199611607-1:2006 Packaging fo

49、r terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsReplaces EN 868-1Reference numberISO 10651-4:2002(E)ISO 2002INTERNATIONAL STANDARD ISO10651-4First edition2002-03-01Lung ventilators Part 4: Particular requirements for operator-powered resuscitators Ventilateurs pulmonaires Partie 4 : Exigences relatives aux ressuscitateurs puissance motrice manuelle ISO 10651-4:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordanc

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