CAN CSA-Z23328-2-2003 Breathing system filters for anaesthetic and respiratory use - Part 2 Non-filtration aspects (First Edition).pdf

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1、 National Standard of CanadaCAN/CSA-Z23328-2-03(ISO 23328-2:2002)International Standard ISO 23328-2:2002 (first edition, 2002-10-15) has been adopted without modification(IDT) as CSA Standard CAN/CSA-Z23328-2-03, which has been approved as a National Standard of Canada by theStandards Council of Can

2、ada.ISBN 1-55397-448-4 October 2003Reference numberISO 23328-2:2002(E)Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects Filtres pour matriel danesthsie et de ranimation respiratoire Partie 2: Aspects autres que filtration The Canadian Standards Association (

3、CSA), The Standards Council of Canada is theunder whose auspices this National Standard has been coordinating body of the National Standards system, produced, was chartered in 1919 and accredited by a federation of independent, autonomousthe Standards Council of Canada to the National organizations

4、working towards the furtherStandards system in 1973. It is a not-for-profit, development and improvement of voluntarynonstatutory, voluntary membership association standardization in the national interest.engaged in standards development and certification The principal objects of the Council are to

5、foster activities. and promote voluntary standardization as a means CSA standards reflect a national consensus of of advancing the national economy, benefiting theproducers and users including manufacturers, health, safety, and welfare of the public, assisting consumers, retailers, unions and profes

6、sional and protecting the consumer, facilitating domestic organizations, and governmental agencies. The and international trade, and furthering internationalstandards are used widely by industry and commerce cooperation in the field of standards.and often adopted by municipal, provincial, and A Nati

7、onal Standard of Canada is a standard whichfederal governments in their regulations, particularly in has been approved by the Standards Council ofthe fields of health, safety, building and construction, Canada and one which reflects a reasonableand the environment. agreement among the views of a num

8、ber of capableIndividuals, companies, and associations across individuals whose collective interests provide to theCanada indicate their support for CSAs standards greatest practicable extent a balance ofdevelopment by volunteering their time and skills to representation of producers, users, consume

9、rs, andCSA Committee work and supporting the Associations others with relevant interests, as may be appropriateobjectives through sustaining memberships. The more to the subject in hand. It normally is a standardthan 7000 committee volunteers and the 2000 which is capable of making a significant and

10、 timelysustaining memberships together form CSAs total contribution to the national interest.membership from which its Directors are chosen. Approval of a standard as a National Standard ofSustaining memberships represent a major source of Canada indicates that a standard conforms to theincome for C

11、SAs standards development activities. criteria and procedures established by the StandardsThe Association offers certification and testing Council of Canada. Approval does not refer to theservices in support of and as an extension to its technical content of the standard; this remains thestandards d

12、evelopment activities. To ensure the continuing responsibility of the accreditedintegrity of its certification process, the Association standards-development organization.regularly and continually audits and inspects products Those who have a need to apply standards arethat bear the CSA Mark. encour

13、aged to use National Standards of CanadaIn addition to its head office and laboratory complex whenever practicable. These standards are subject in Toronto, CSA has regional branch offices in major to periodic review; therefore, users are cautioned centres across Canada and inspection and testing to

14、obtain the latest edition from the organizationagencies in eight countries. Since 1919, the preparing the standard.Association has developed the necessary expertise to The responsibility for approving National Standards meet its corporate mission: CSA is an independent of Canada rests with theservic

15、e organization whose mission is to provide an Standards Council of Canadaopen and effective forum for activities facilitating the 270 Albert Street, Suite 200exchange of goods and services through the use of Ottawa, Ontario, K1P 6N7standards, certification and related services to meet Canadanational

16、 and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the respons

17、ibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationStandards Update ServiceCAN/CSA-Z23328-2-03October 2003Title: Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspectsPagination: 11 pa

18、ges (CSA/1, iv, and 5 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 2015543.If you require assistance, please e-mail techsupportcsagroup.org or ca

19、ll 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.Breathing system filters for anaesthetic andCAN/CSA-Z23328-2-03 respiratory use Part 2: Non-filtration aspectsOctober 2003 Canadian Standards Association CSA/1CAN/CSA-Z23328-

20、2-03Breathing system filters foranaesthetic and respiratory use Part 2: Non-filtration aspectsCSA PrefaceThis is the first edition of CAN/CSA-Z23328-2, Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects, which is an adoption without modification of the identi

21、cally titled ISO(International Organization for Standardization) Standard 23328-2 (first edition, 2002-10-15). At thetime of publication, ISO 23328-2:2002 is available from ISO in English only.This Standard was reviewed for Canadian adoption by the CSA Subcommittee on RespiratoryTechnology, under th

22、e jurisdiction of the Technical Committee on Anaesthetic Equipment, RespiratoryTechnology, and Critical Care Equipment and the Strategic Steering Committee on Health CareTechnology, and has been formally approved by the Technical Committee. A list of the members of theTechnical Committee is availabl

23、e upon request. This Standard has been approved as a National Standardof Canada by the Standards Council of Canada. October 2003 Canadian Standards Association 2003All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission ofthe publisher.

24、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 to Canadian Standards Association 5060 Spectrum Way,

25、Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caReference numberISO 23328-2:2002(E)ISO 2002INTERNATIONAL STANDARD ISO23328-2First edition2002-10-15Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects Filtres pour matriel dane

26、sthsie et de ranimation respiratoire Partie 2: Aspects autres que filtration ISO 23328-2:2002(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 embedded

27、 are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Det

28、ails of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem

29、relating to it is found, please inform the Central Secretariat at the address given below. ISO 2002 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm,

30、without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch ii ISO 2002 All rights reservedISO 23328-2

31、:2002(E) ISO 2002 All rights reserved iiiContents Page Foreword iv Introduction. v 1 Scope 1 2 Normative references 1 3 Terms and definitions. 1 4 BSF port connectors. 2 4.1 BSF breathing system and patient connection ports 2 4.2 Accessory ports 2 5 Test methods . 2 5.1 Ambient conditions of test. 2

32、 5.2 Measurement of pressure drop . 2 5.3 Test for gas leakage 3 6 Packaging of sterile BSF 3 7 Marking. 3 7.1 Use of symbols 3 7.2 Marking of BSF 3 7.3 Marking of package. 3 7.4 BSF intended for single use. 3 8 Information to be provided by the manufacturer. 4 Bibliography 5 ISO 23328-2:2002(E) iv

33、ISO 2002 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body intereste

34、d in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Com

35、mission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the techni

36、cal committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 23328 may be the subject of patent right

37、s. ISO shall not be held responsible for identifying any or all such patent rights. ISO 23328-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. ISO 23328 consists of the following parts, under the gener

38、al title Breathing system filters for anaesthetic and respiratory use: Part 1: Salt test method to assess filtration performance Part 2: Non-filtration aspects ISO 23328-2:2002(E) ISO 2002 All rights reserved vIntroduction This part of ISO 23328 gives requirements for non-filtration aspects of breat

39、hing system filters (BSF). BSF are used to reduce particulates, including microorganisms, in gases delivered to and exhaled from patients. BSF are exposed to various levels of humidity during clinical use. Exposure of the BSF to humidified air to simulate clinical use forms part of the test method,

40、as it is possible that such exposure can influence the filtration performance of the BSF. A test method to assess filtration performance is found in ISO 23328-1. INTERNATIONAL STANDARD ISO 23328-2:2002(E) ISO 2002 All rights reserved 1Breathing system filters for anaesthetic and respiratory use Part

41、 2: Non-filtration aspects 1 Scope This part of ISO 23328 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The te

42、st method is intended for BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. NOTE A method fo

43、r assessing filtration performance of BSF is given in ISO 23328-1. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 23328. For dated references, subsequent amendments to, or revisions of, any

44、of these publications do not apply. However, parties to agreements based on this part of ISO 23328 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document refer

45、red to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bear

46、ing connectors ISO 9360-1:2000, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml ISO 11607, Packaging for terminally sterilized medical devices IEC 60601-1:1988, Medical electr

47、ical equipment Part 1: General requirements for safety; Amendment 1:1991 and Amendment 2:1995 3 Terms and definitions For the purposes of this part of ISO 23328, the following terms and definitions apply: 3.1 breathing system filter BSF device intended to reduce transmission of particulates, includi

48、ng microorganisms, in breathing systems ISO 23328-2:2002(E) 2 ISO 2002 All rights reserved3.2 BSF breathing system port port of the BSF that connects to the breathing system 3.3 BSF patient connection port port of the BSF intended for connection to a device such as a tracheal or tracheostomy tube co

49、nnector or a face mask 3.4 BSF accessory port port of the BSF that can be connected to an accessory device for purposes such as gas sampling, monitoring and pressure measurement 3.5 BSF internal volume volume contained in the BSF, when unpressurized, minus the volume of all solid elements within the BSF and the volume inside all female connectors 3.8 pressure drop difference between the pressure measured in a gas stream flowing into a BSF and the pressure measured in the gas stream flowing out of the