CAN CSA-Z10083-2008 Oxygen concentrator supply systems for use with medical gas pipeline systems (First Edition).pdf

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1、 Reference numberISO 10083:2006(E)ISO 2006INTERNATIONAL STANDARD ISO10083Second edition2006-07-15Oxygen concentrator supply systems for use with medical gas pipeline systems Systmes dapprovisionnement par concentrateurs doxygne pour utilisation dans des rseaux de distribution de gaz mdicaux National

2、 Standard of CanadaCAN/CSA-Z10083-08International Standard ISO 10083:2006 (second edition, 2006-07-15) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z10083-08, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55436-788-7 A

3、ugust 2008 International Organization for Standardization (ISO), 2006. All rights reserved. NOT FOR RESALE. Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This proce

4、ss brings together volunteers representing varied viewpoints and interests to achieve consensus 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.

5、Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, 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 merchantabilit

6、y, or its non-infringement of any third partys intellectual property rights. CSA does not warrant 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,

7、rule, or regulation. 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

8、OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, 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 OR POSSESSION OR USE OF THIS DOCUMENT, E

9、VEN IF CSA HAS BEEN 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 any person or entity or to perform any duty owed by any person or ent

10、ity to another person or entity. The information in this document is directed to those who have 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

11、 document. CSA is a private not-for-profit company that publishes voluntary standards and related 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

12、 the users of this document (whether it be in printed or electronic form), CSA is the owner, or 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 contai

13、ned in this document, whether or not such inventions and trade secrets are protected by patents 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

14、 give rise to a right in CSA and/or others to seek legal redress for such use, modification, copying, 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 elemen

15、ts of this standard may be the subject of patent rights. CSA shall not be held responsible for identifying 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 t

16、his documentThis document is being provided by CSA for informational and non-commercial use only. 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 d

17、ocument; and.print this document if it is in PDF format. Limited copies of this document in print or paper form may be 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 othe

18、rs to.alter this document in any way or remove this Legal Notice 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

19、 this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.Standards Update ServiceCAN/CSA-Z10083-08August 2008Title: Oxygen

20、concentrator supply systems for use with medical gas pipeline systemsPagination: 60 pages (CSA/1CSA/11, ivii, and 42 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 thi

21、s publication is 2419094.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.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 St

22、andard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National 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 na

23、tional consensus of producers and users including manufacturers, consumers, retailers, unions and professional 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, pa

24、rticularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, 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 objecti

25、ves through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships 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 Associatio

26、n offers certification and testing services in support of and as an extension to its standards development activities. 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 a

27、nd laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection 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 m

28、ission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and international needs.For further information on CSA services, write toCanadian Standards Association506

29、0 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is thecoordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations working towards the furtherdevelopment and improvement of voluntarystandardization in the nat

30、ional interest.The principal objects of the SCC are to fosterand promote voluntary standardization 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

31、internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a standardprepared or 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

32、 standard; this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of capable individuals whose collective interests provide, to the greatest practicable extent, a balance of representation of general interests, producers, regulators, users (including consumers

33、), and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard 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 p

34、eriodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO which publishes the standard.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme

35、nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard 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 S

36、tandards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in August 2008 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 Sto

37、re at www.ShopCSA.caCAN/CSA-Z10083-08Oxygen concentrator supply systems for use with medical gas pipeline systemsPrepared byInternational Organization for StandardizationRegistered trade-mark of Canadian Standards AssociationReviewed byCAN/CSA-Z10083-08Oxygen concentrator supply systems for usewith

38、medical gas pipeline systemsAugust 2008 Canadian Standards Association CSA/3CAN/CSA-Z10083-08Oxygen concentrator supply systems for use with medical gas pipeline systemsCSA PrefaceThis is the first edition of CAN/CSA-Z10083, Oxygen concentrator supply systems for use with medical gas pipeline system

39、s, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 10083 (second edition, 2006-07-15). This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Medical Gas Systems, under the jurisdiction of th

40、e CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the 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 S

41、tandards Council of Canada.August 2008 Canadian Standards Association 2008All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission ofthe publisher. ISO material is reprinted with permission. Where the words “this International Standard” a

42、ppear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this 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 purch

43、ase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free1-800-463-6727 or 416-747-4044.CAN/CSA-Z10083-08Oxygen concentrator supply systems for usewith medical gas pipeline systemsCSA/4 Canadian Standards Association August 2008Canadian deviationsIntrodu

44、ctionAdd the following note NOTE 1A Throughout this Standard, where the term “oxygen-enriched air” appears, replace it with the term “Oxygen 93”.Replace the fourth paragraph with the followingThe decision to use Oxygen 93 should be made at an early stage by the medical staff of the health care facil

45、ity and is outside the scope of this Standard. The possible use of a mixture of Oxygen 93 and oxygen is also a decision of the health care facility. The use of a supply system incorporating oxygen concentrator(s) might require the approval of regional or national authorities.Replace the sixth paragr

46、aph with the followingIt is recommended that terminal units designated for oxygen be used.2 Normative references Add the following CSA (Canadian Standards Association)Where reference is made to CSA publications, such reference shall be considered to refer to the latest edition and all amendments pub

47、lished to that edition. This Standard refers to the following publications, and the years shown indicate the latest editions available at the time of printing:B51-03 (R2007)Boiler, pressure vessel, and pressure piping codeB339-08Cylinders, spheres, and tubes for the transportation of dangerous goods

48、B340-08Selection and use of cylinders, spheres, tubes, and other containers for the transportation of dangerous goods, Class 2The following National Standard of Canada, published by the Canadian Standards Association, is a CSA Standard based on an ISO Standard. The requirements of this CSA Standard

49、shall take precedence over the International Standard on which it is based. Any reference in CAN/CSA-Z10083 to the International Standard shall be replaced by a reference to the equivalent Canadian Standard. CAN/CSA-Z7396.1-06Medical gas pipeline systems Part 1: Pipelines for medical gases and vacuumGovernment of CanadaTransportation of Dangerous Goods Act, S.C. 1992, c. 34, and the RegulationsISO/IEC (International Organization for Standardization/International Electrotechnical Commission)ISO/IEC 17025:2005General requirements for the competence

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