CAN CSA-Z23328-1-2004 Breathing system filters for anaesthetic and respiratory use - Part 1 Salt test method to assess filtration performance (First Edition).pdf

1、 Reference numberISO 23328-1:2003(E)ISO 2003Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance Filtres pour matriel danesthsie et de ranimation respiratoire Partie 1: Mthode dessai saline pour lvaluation de lefficacit de filtration

2、National Standard of CanadaCAN/CSA-Z23328-1-04(ISO 23328-1:2003)International Standard ISO 23328-1:2003 (first edition, 2003-08-15) has been adopted without modification(IDT) as CSA Standard CAN/CSA-Z23328-1-04, which has been approved as a National Standard of Canada by theStandards Council of Cana

3、da.ISBN 1-55397-618-5 August 2004The 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 system in 1973. It is a not-for-profit, nonstatutory, voluntary

4、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 organizations, and governmental agencies. The standards are used widely by in

5、dustry 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 associations across Canada indicate their support for CSAs standards

6、 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 form CSAs total membership from which its Directors are chosen. Sus

7、taining 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 ensure the integrity of its certification process, the Association

8、 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 agencies in eight countries. Since 1919, the Association has dev

9、eloped 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 use of standards, certification and related services to meet nat

10、ional and international needs. For further information on CSA services, write to Canadian Standards Association 5060 Spectrum Way, Suite 100 Mississauga, Ontario, L4W 5N6 Canada The Standards Council of Canada is the coordinating body of the National Standards system, a federation of independent, au

11、tonomous organizations working towards the further development and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and promote voluntary standardization as a means of advancing the national economy, benefiting the health, safety,

12、and welfare of the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation 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 re

13、flects a reasonable agreement among the views of a number of capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers, users, consumers, and others with relevant interests, as may be appropriate to the subject in hand. It norm

14、ally is a standard which is capable of making a significant and timely contribution to the national interest. Approval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not re

15、fer to the technical content of the standard; this remains the continuing responsibility of the accredited standards-development organization. Those who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic rev

16、iew; therefore, users are cautioned to obtain the latest edition from the organization preparing the standard. The responsibility for approving National Standards of Canada rests with the Standards Council of Canada 270 Albert Street, Suite 200 Ottawa, Ontario, K1P 6N7 Canada Although the intended p

17、rimary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users to judge its suitability for their particular purpose. Registered trade-mark of Canadian Standards Association Breathing system filters for anaesthetic and respiratory

18、use CAN/CSA-Z23328-1-04 Part 1: Salt test method to assess filtration performance August 2004 Canadian Standards Association CSA/1 CAN/CSA-Z23328-1-04 Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance CSA Preface This is the first

19、edition of CAN/CSA-Z23328-1, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 23328-1 (first editio

20、n, 2003-08-15). At the time of publication, ISO 23328-1:2003 is available from ISO in English only. This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Respiratory Technology, under the jurisdiction of the Technical Committee on Anaesthetic Equipment, Respiratory Technology,

21、and Critical Care Equipment and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. A list of the members of the Technical Committee is available upon request. This Standard has been approved as a National Standard of Canada by the S

22、tandards Council of Canada. August 2004 Canadian Standards Association 2004 All rights reserved. No part of this 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

23、” 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, Suite 100, Mississauga, Ontario, Canada L4W 5N6 1-800-463-6727 416-747-4044 www.csa.ca

24、 Reference numberISO 23328-1:2003(E)ISO 2003INTERNATIONAL STANDARD ISO23328-1First edition2003-08-15Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance Filtres pour matriel danesthsie et de ranimation respiratoire Partie 1: Mthode de

25、ssai saline pour lvaluation de lefficacit de filtration ISO 23328-1:2003(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 are licensed to and

26、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. Details of the software

27、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 relating to it is fou

28、nd, please inform the Central Secretariat at the address given below. ISO 2003 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, without permission in

29、 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.org Web www.iso.org ii ISO 2003 All rights reservedISO 23328-1:2003(E) ISO 2003 A

30、ll rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Terms and definitions. 1 3 Method 2 3.1 Principle . 2 3.2 Test conditions 2 3.3 Apparatus. 2 3.4 Conditioning of BSF . 2 3.5 Sample size 3 3.6 Procedure. 3 4 Calculation and expression of test results. 4 5 Test report 4 Annex

31、 A (normative) Conditioning of BSF 5 Annex B (informative) Aerosol particle size distribution . 8 Annex C (informative) Rationale for chosen test method 9 Annex D (informative) Clauses of this part of ISO 23328 addressing the essential principles of ISO/TR 16142 . 11 Bibliography . 12 ISO 23328-1:20

32、03(E) iv ISO 2003 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

33、interested 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 Electrotech

34、nical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by t

35、he technical 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 document may be the subject of patent right

36、s. ISO shall not be held responsible for identifying any or all such patent rights. ISO 23328-1 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

37、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 23328-1:2003(E) ISO 2003 All rights reserved vIntroduction This part of ISO 23328 gives a method of test for assessing the filtration pe

38、rformance of breathing system filters (BSF). BSF are used to reduce the number of 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 u

39、se forms part of this method (see Annex A), as it is possible that such exposure can influence the filtration performance of the BSF. In the test, the BSF is challenged with sodium chloride particles of the most penetrating size range, i.e. 0,1 m to 0,3 m (see Annex C). It is recognized that transmi

40、ssion of microorganisms across a filter can occur due to “channeling” and “grow-through”. There are at present no accepted methods to quantify these occurrences. This test method is for comparison purposes only, and has no proven clinical relevance. The results are specific to the test method and no

41、 risk factor should be derived from it. INTERNATIONAL STANDARD ISO 23328-1:2003(E) ISO 2003 All rights reserved 1Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance 1 Scope This part of ISO 23328 gives a short-term airborne sodium ch

42、loride particle challenge test method for assessing the filtration performance of breathing system filters (BSF) intended for the filtration of respired gases. This part of ISO 23328 is applicable to BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those

43、 designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. NOTE Non-filtration aspects of BSF are addressed in ISO 23328-2. 2 Terms and definitions For the purposes of this document, the following term

44、s and definitions apply. 2.1 breathing system filter BSF device intended to reduce transmission of particulates, including microorganisms, in breathing systems 2.2 challenge concentration concentration of sodium chloride particles in the airstream as it reaches the BSF NOTE Challenge concentration i

45、s expressed in milligrams per cubic metre. 2.3 penetration concentration concentration of sodium chloride particles in the airstream flowing out of the BSF NOTE Penetration concentration is expressed in milligrams per cubic metre. 2.4 penetration value concentration of sodium chloride particles pass

46、ing through the BSF as a percentage of the concentration in the challenge 2.5 percent filtration efficiency 100 minus the penetration value ISO 23328-1:2003(E) 2 ISO 2003 All rights reserved3 Method 3.1 Principle 3.1.1 The ability of a BSF to remove particles is measured by nebulizing a sodium chlor

47、ide solution into an airstream and passing the sodium chloride particles produced by the nebulizer through the BSF. Annexes B and C give further explanation. 3.1.2 The generation of aerosols from a nebulizer produces particles that are charged electrostatically. The magnitude of the charge is reduce

48、d by mixing the airstream containing the particles with a flow of ionized air so that, when the two flows are mixed, the particles are neutralized to the Boltzmann equilibrium state. 3.1.3 The flows chosen for testing represent the typical flows likely to be encountered during the intended use of th

49、e BSF. 3.1.4 The performance of the BSF is assessed by measuring the penetration concentration of sodium chloride particles in the airstream leaving the BSF and comparing this with the challenge concentration in the airstream entering the BSF. BSF are tested in the unused state as removed from the packaging and after conditioning to simulate clinical use. 3.2 Test conditions The ambient conditions during the tests shall be: temperature: (23 2) C; relative humidity: (60 15) % RH; and pressure: