CAN CSA-Z10651-3-1998 Lung Ventilators for Medical Use - Part 3 Particular Requirements for Emergency and Transport Ventilators (First Edition General Instruction No 1 July 1998).pdf

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1、National Standard of Canada CAN/CSA-Z10651-3-98 International Standard IS0 10651-3:1997 (first edition, 199 7-01 - 1 S), has been adopted with Canadian deviations as CSA Standard CAN/CSA-Z1065 1-3-98, which has been approved as a National Standard of Canada by the Standards Council of Canada. ISSN 0

2、31 7-5669 July 1998 Lung ventilators for medical use - Part 3: Part icu la r req u i rem ents for em erg en cy a n d transport ventilators (Reaf f i r med 2003) Ventiiateurs pulmonaires a usage medical - Partie 3. Exigences particuheres pour ventilateurs de secours et de transport Reference number I

3、S0 70651-3.1997() LAssociation canadienne de normalisation (CSA), sous les auspices de laquelle cette Norme nationale a et6 preparee, a requ ses lettres patentes en 191 9 et son accreditation au sein du Systkme de normes nationales par le Conseil canadien des normes en 1973. Association daffiliation

4、 libre, sans but lucratif ni pouvoir de reglementation, elle se consacre a Idaboration de normes et a la certilication. Les normes CSA reflktent le consensus de producteurs et dusagers de partout au pays, au nombre desquels se trouvent des fabricants, des consommateurs, des detaillants et des repres

5、entants de syndicats, de corps professionnels et dagences gouvernementales. Lutilisation des normes CSA est Ires rbpandue dans Iindustrie et le commerce, et leur adoption B divers ordres de legislation, tant municipal et provincial que f8dera1, est chose courante, particulierement dans les domaines

6、de la sante, de la securitk, du bitiment, de la construction et de Ienvironnement. Les Canadiens dun bout a Iautre du pays temoignent de leur appui au travail de normalisation mene par la CSA en participant benevolement aux travaux des comites de la CSA et en appuyant ses objectifs par leurs cotisat

7、ions de membres de soutien. Les quelque 7000 volontaires faisant partie des comites et les 2000 membres de soutien constituent lensemble des membres de la CSA parmi lesquels ses administrateurs sont choids. Les cotisations des membres de soutien representent une source importante de revenu pour les

8、sewices de soutien a la normalisation volontaire. LAssociation offre des services de Certification et de mise a Iessai qui appuient et completent ses activites dans le domaine de Ielaboration de normes. De maniere a assurer Iintegnte de son processus de certification, IAssociation procede de facon r

9、egulibre et continue a Iexarnen et A linspection des produits portant la marque CSA. Outre son siege social et ses laboratoires 2i Etobicoke, la CSA possede des bureaux regionaux dans des centres vitaux partout au Canada, de mime que des agences dinspection et dessai dans huit pays. Depuis 191 9, IA

10、ssociation a parfait les connaissances techniques qui lui permettent de remplir sa mission dentreprise, a savoir la CSA est un organisme de services independant dont la mission est doffrir une tribune libre et efficace pour la realisation dactivites facilitant Ibchange de biens et de services par Ii

11、ntermediaire de services de normalisation de certification et autres, pour repondre aux besoins de nos clients, tant a lechelle nationale quinternationale. The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by

12、 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 national consensus of producers and users - including manufacturers

13、, 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, particularly in the fields of health, safety, building and constr

14、uction, and the environment. supporting the Associations objectives 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 ol

15、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 ensure the integrity of its certification process, the Association regularly and continually audits and inspects p

16、roducts that bear the CSA Mark. In addition to its head office and laboratory complex in Etobicoke, 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 cor

17、porate 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 use of standards, certification and related services to meet national and international needs. For further inf

18、ormation on CSA services, write to 178, boulevard Rexdale 178 Rexdale Boulevard Individuals, companies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and skills to CSA Committee work and Pour plus amdes renseiqnements sur les services

19、 de la CSA, sadresser h Association canadienne de normalisatinon Canadian Standards Association Etobicoke, Ontario, M9W 1 R3 Canada Le Conseil canadien des normes est lorganisme de coordination du Systerne de normes nationales, une federation dorganismes independants et autonomes qui travaillent au

20、developpement et a Iamelioration de la normalisation volontaire dans Iinteret national. Les principaux buts du Conseil sont dencourager et de promouvoir la normalisation volontaire comme rnoyen damhliorer Ieconomie nationale, dameliorer la sante, la securite et le bien-Btre du public, daider et de p

21、roteger e consommateur, de faciliter le commerce national et international et de favoriser la coopbration internationale dans le domaine de la normalisation. Une Norme nationale du Canada est une norme, approuvke par le Conseil canadien des normes, qui rellete une entente raisonnable parmi les point

22、s de vue dun certain nombre de personnes competentes dont les inter- cet aspect demeure la responsabilite de Iorganisme redacteur de normes accredit$ periodiques cest pourquoi il est recornmande aux utilisateurs de se procurer Iedition la plus recente de la norme aupres de Iorganisme qui Ia preparee

23、. Lapprobation dune norme en tant que Norme nationale du Canada indique quelle est coniorme aux methodes et criteres etablis par le Conseil canadien des normes. ll est recommande aux personnes qui ont besoin de normes de se servir des Normes nationales du Canada lorsque la chose est possible. Ces no

24、rmes font Iobjet dexamens The Standards Council of Canada is the coordinating body of the National Standards system, a federation of independent, autonomous organizations working towards the further development and improvement of voluntary standardization in the national interest. The principal obje

25、cts of the Council are to foster and promote voluntary standardization as a means of advancing the national economy, benefiting the health, safety, and welfare of the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperatio

26、n in the field of standards. A National Standard of Canada is a standard which has been approved by the Standards Council of Canada and one which reflects a reasonable agreement among the views of a number of capable individuals whose collective interests provide to the greatest practicable extent a

27、 balance of representation of producers, users, consumers, 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. Approval of a standard as a National Stand

28、ard of Canada indicates that a standard conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not refer to the technical content of the standard: this remains the continuing responsibility of the accredited standards-development organization. Those who

29、 have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest edition from the organization preparing the standard. La responsabilite dapprouver les Normes n

30、ationales du Canada incornbe au The responsibility for approvinq National Standards of Canada rests with the Conseil canadien des normes Standards Council of Canada 45, rue OConnor, Bureau 1200 45 OConnor Street, Suite 1200 Ottawa, Ontario, K1 P 6N7 Canada Bien que le but premier vise par ceffe norm

31、e soit knonce sous sa rubrique Domaine dapplication, ii est important de retenir quil incombe a Iutilisateur de juger si la norme convient a ses besoins particuliers. Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the respon

32、sibility of the user to judge its suitability for their parficular purpose. General Instruction No. 1CAN/CSA-Z10651-3-98July 1998Title: Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilatorsPagination: 36 pages (CSA/1-CSA/4, i-iv, and 28 text)To regi

33、ster 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 2008005.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups p

34、olicy on privacy at csagroup.org/legal to find out how we protect your personal information.Lung ventilators for medical use - Port 3: Particular requirements for emergency and transport ventilators CAN/CSA-Z70657-3-98 CAN/CSA-Z10651-3-98 Lung ventilators for medical use - Part 3: Particular require

35、ments for emergency and transport ventilators CSA Preface This is the first edition of CSA Standard CAN/CSA-Z10651-3, Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators, which is an adoption, with Canadian deviations, of the identically titled

36、IS0 (International Organization for Standardization) Standard 10651 -3:7997 (first edition, 1997-01 -1 5). It is one of a series of CSA Standards addressing lung ventilators, including anaesthesia, critical care, home care, and neonatal ventilators- Clause 1.2 on Normative References lists Canadian

37、National Standards that are based on their international equivalents, and for which Canadian deviations have been identified. The requirements of these Standards take precedence over the International Standards on which they are based, so that any reference in IS0 10651-3:1997 to the International S

38、tandard shall be replaced with the equivalent Canadian Standard. This Standard was reviewed for Canadian adoption by the Working Group on Transport Ventilators and the Subcommittee on Respiratory Technology under the jurisdiction of the Technical Committee on Anaesthetic Equipment, Respiratory Techn

39、ology, and Critical Care Equipment, and the Strategic Steering Committee on Health Care Technology. It was approved by the Technical Committee. A list of the members of these Committees is available upon request. This Standard has been approved as a National Standard of Canada by the Standards Counc

40、il of Canada. luiy 7 998 0 Canadian Standards Association - 1948 All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. I50 material is reprinted with permission. inquiries regarding this National Standard of Canada sh

41、ould be addressed to Canadian Standards Association, 7 78 Rexdale Boulevard, Etobicoke, Ontario, Canada, M9W 7 R3. Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators CAN/CSA-ZI 065 7-3-98 Canadian Deviations Section 1: General Clause 1.2 Normat

42、ive references Add the fo 110 wing CSA Standards Medical Electrical Equipment, Part I: General Requirements for Safety; CAN/CSA-C22.2 NO. 601.1 -M90 (R1997), CAN/CSA-IS0 9703.1 -97, Anaesthesia and Respiratory Cure Alarm Signals - Port 7 : Visual Alarm Signals; CAN/CSA-IS0 9703.2-97, Anaesthesia and

43、 Respiratory Care Alarm Signals - Part 2: Auditory Alarm Signals; Resuscitators lntended for Use with Humans. CAN/CSA-Z8382-94, EO* Standards Anaesthetic and respiratory equipment - Conical connectors - Part 7 : Cones and sockets. 5356-1 1996, 5356-2: 1987 Anaesthetic an# respiratory equipment - Con

44、ical connectors - Part 2: Screw-threaded weight-bearing connectors . *International Organization for Standardization Clause 1.4 General requirements Add the following The requirements of CAN/CSA-C22.2 No. 601 .I shall take precedence over those of IEC 601 -1 I as referred to in IS0 10651 -3:1997. 3.

45、6 1) Delete this ciuuse Note: This clause refers to illumination parameters for a test procedure and has been inadvertently retained from a previous draft with different numbering. Clause 1.7 Identification, marking and documents 6.1 ad) Delete the clause and replace with the following Each ventilat

46、or shall be provided with a pre-use checklist that summarizes the test procedures that the manufacturer considers to be mandatory, in order to ensure that normal operating conditions exist. Means shall be provided to ensure that the checklist remains with the device, such as permanent marking, the u

47、se of an electronic display, or by requiring the use of a special tool to remove the checklist from the device. 6.1 af) 7) Move this clause to 6.7 ae) and renumber it as 6.7 ae) #A Note: This requirement is not relevant to breathing attachments for single-patient use. CSA/2 july 7 9 98 f ung ventila

48、tors for medical use - Part 3: Particular requirements for emergency ond transport ventilators CAN/CSA-Z7065 7 -3-98 6.1 ai) Delete the clause and replace with the following If gas-specific colour coding of flow controls and flexible hose is provided, it shall be in accordance with IS0 32, or the cu

49、rrent CSA standard, where applicable. 6.8.3 a) 5) Delete the clause and replace with the following Conditions under which any measured or displayed flow, volume, or ventilation (dV/dt) are to be expressed (eg, ATPD, BTPS) and the condition and composition of gas in the corresponding sensor so that the display complies with the accuracy requirements specified in clause 51.9, section 8.2, of IS0 10451 -311 997. 6.8.3 a) 9) Delete the third paragraph and replace with the following A statement that the operator wil