1、 Reference numberISO 23747:2007(E)ISO 2007INTERNATIONAL STANDARD ISO23747First edition2007-07-15Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans Matriel danesthsie et de ranimation respiratoire Dbitmtres dbit
2、 de pointe expiratoire pour lvaluation de la fonction pulmonaire chez les tres humains respirant spontanment National Standard of CanadaCAN/CSA-Z23747-08International Standard ISO 23747:2007 (first edition, 2007-07-15) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z23747-08,
3、 which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55436-787-0 August 2008 International Organization for Standardization (ISO), 2007. All rights reserved. NOT FOR RESALE. Legal Notice for StandardsCanadian Standards Association (CSA) standards are
4、 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 and develop a standard. Although CSA administers the process and establishes rules to pr
5、omote 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, warranties, or conditions of any kind, express or implied, including, without limitation, im
6、plied 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 warrant the accuracy, completeness, or currency of any of the information published in this do
7、cument. 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 COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRE
8、CT, 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 BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), O
9、R 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.In publishing and making this document available, CSA is not undertaking to render prof
10、essional 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 the appropriate degree of experience to use and apply its contents, and CSA accepts no r
11、esponsibility 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 related documents. CSA has no power, nor does it undertake, to enforce compliance with the con
12、tents 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 the authorized licensee, of all works contained herein that are protected by copyright,
13、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 and applications for patents. Without limitation, the unauthorized use, modification, co
14、pying, 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, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all inte
15、llectual 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 identifying any or all such patent rights. Users of this standard are expressly advised t
16、hat 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. The user of this document is authorized to do only the following:If this document is i
17、n 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 document in print or paper form may be distributed only to persons who are authorized by CSA to have suc
18、h 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 authorization from CSA; or.make an electronic copy of this docum
19、ent.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 them immediately. Use of this document constitutes your acceptance
20、 of the terms and conditions of this Legal Notice.Standards Update ServiceCAN/CSA-Z23747-08August 2008Title: Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humansPagination: 32 pages (CSA/1CSA/4, iv, and 23 text)T
21、o 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 2419095.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Gr
22、oups 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 National Standards
23、 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 organization
24、s, 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, companies, and ass
25、ociations 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 together fo
26、rm 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 activities. To e
27、nsure 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 and testing
28、 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 through the
29、 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 thecoordinating body o
30、f 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 advancing t
31、he 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 reviewed by
32、 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 capable indivi
33、duals 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 which is cap
34、able 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 standard.The respo
35、nsibility 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 Standard is stat
36、ed 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 August 2008 by Canadian S
37、tandards 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-Z23747-08Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment o
38、f pulmonary function in spontaneously breathing humansPrepared byInternational Organization for StandardizationRegistered trade-mark of Canadian Standards AssociationReviewed byCAN/CSA-Z23747-08Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment ofpulmonary function
39、in spontaneously breathing humansAugust 2008 Canadian Standards Association CSA/3CAN/CSA-Z23747-08Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humansCSA PrefaceThis is the first edition of CAN/CSA-Z23747, Anaest
40、hetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 23747 (first edition, 2007-0
41、7-15). 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 the Strategic Steering Committee on Health Care Technology
42、, 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. August 2008 Canadian Standards Association 2008All rights reserved. No part of this publication may be reproduced in any form whatsoever w
43、ithout the prior permission ofthe 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 this National Standard of Canada should be addressed toCanadi
44、an 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 1-800-463-6727 or 416-747-4044.CAN/CSA-Z23747-08Anaesthetic a
45、nd respiratory equipment Peak expiratory flow meters for the assessment ofpulmonary function in spontaneously breathing humansCSA/4 Canadian Standards Association August 2008Canadian deviations2 Normative referencesAdd the followingCSA (Canadian Standards Association)The following National Standards
46、 of Canada, published by the Canadian Standards Association, are adoptions of IEC and ISO Standards. The requirements of these CSA Standards shall take precedence over the International Standards on which they are based; any reference in CAN/CSA-Z23747 to the International Standard shall be replaced
47、 by a reference to the equivalent Canadian Standard.CAN/CSA-C22.2 No. 60601-1:08Medical electrical equipment Part 1: General requirements for basic safety and essential performanceCAN/CSA-ISO 14937-01 (R2006)Sterilization of health care products General requirements for characterization of a sterili
48、zing agent and the development, validation and routine control of a sterilization process for medical devicesCAN/CSA-ISO 14971:07Medical devices Application of risk management to medical devicesReference numberISO 23747:2007(E)ISO 2007INTERNATIONAL STANDARD ISO23747First edition2007-07-15Anaesthetic
49、 and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans Matriel danesthsie et de ranimation respiratoire Dbitmtres dbit de pointe expiratoire pour lvaluation de la fonction pulmonaire chez les tres humains respirant spontanment ISO 23747:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are emb