BS-EN-13328-2-2002.pdf
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1、BRITISH STANDARD BS EN 13328-2:2002 Incorporating Corrigendum No. 1 and Amendment No. 1 Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects The European Standard EN 13328-2:2002, with the incorporation of amendment A1:2003 has the status of a British Standard
2、ICS 11.040.10 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13328-2:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the au
3、thority of the Standards Policy and Strategy Committee on 27 November 2002 BSI 4 February 2004 ISBN 0 580 40853 1 National foreword This British Standard is the official English language version of EN 13328-2:2002, including amendment A1:2003. The UK participation in its preparation was entrusted to
4、 Technical Committee CH/45, Tracheal tubes and related equipment, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred
5、 to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provision
6、s of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or
7、proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover. The
8、BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 14268 Corrigendum No. 1 18 December 2002Correction to title 149464 February 2004New definition 3.6 and additional list item k) to Clause 8 Licensed Cop
9、y: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13328-2 November 2002 + A1 December 2003 ICS 11.040.10 English version Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtra
10、tion aspects (includes amendment A1:2003) Filtres pour systmes respiratoires utiliss en anesthsie et soins respiratoires - Partie 2: Proprits autres que la filtration (inclut lamendement A1:2003) Filter fr Atemsysteme zur Anwendung bei Ansthesie und Beatmung - Teil 2: Aspekte, die nicht die Filtrati
11、on betreffen (enthlt nderung A1:2003) This European Standard was approved by CEN on 8 August 2002, and amendment A1 was approved by CEN on 21 November 2003. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
12、status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A
13、 version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, F
14、rance, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart
15、, 36 B-1050 Brussels 2002 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13328-2:2002 + A1:2003 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 2 Con
16、tents page Foreword3 1 Scope 4 2 Normative references4 3 Terms and definitions .4 4 BSF port connectors .5 4.1 Breathing system and patient connection ports5 4.2 Accessory ports.5 5 Test methods5 5.1 Ambient conditions of test .5 5.2 Measurement of pressure drop5 5.3 Test method for gas leakage5 6 R
17、equirements for BSFs supplied sterile .6 6.1 Sterility assurance.6 6.2 Packaging of BSFs supplied sterile.6 7 Marking.6 7.1 Use of symbols 6 7.2 Marking of BSF.6 7.3 Marking of package .6 7.4 BSF intended for single use .6 8 Information to be provided by the manufacturer .7 Annex ZA (informative) Cl
18、auses of this European Standard addressing essential requirements or other provisions of EU Directives8 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 3 Foreword This document (EN 13328-2:2002) has been prepared by Techn
19、ical Committee CEN /TC 215, “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2003, and conflicting national sta
20、ndards shall be withdrawn at the latest by May 2003. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex Z
21、A, which is an integral part of this document. EN 13328 consists of the following parts under the general title Breathing system filters for anaesthetic and respiratory use : Part 1 : Salt test method to assess filtration performance Part 2 : Non-filtration aspects According to the CEN/CENELEC Inter
22、nal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switz
23、erland and the United Kingdom. Foreword to amendment A1 This document (EN 13328-2:2002/A1:2003) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI. This Amendment to the European Standard EN 13328-2:2002 shall be given
24、 the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2004, and conflicting national standards shall be withdrawn at the latest by June 2004. According to the CEN/CENELEC Internal Regulations, the national standards organizations of t
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