BS-EN-ISO-1135-4-2004.pdf
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1、BRITISH STANDARD BS EN ISO 1135-4:2004 Transfusion equipment for medical use Part 4: Transfusion sets for single use The European Standard EN ISO 1135-4:2004 has the status of a British Standard ICS 11.040.20 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:17 GMT+00:00 2006, Uncontrol
2、led Copy, (c) BSI BS EN ISO 1135-4:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 4 August 2004 BSI 4 August 2004 ISBN 0 580 44209 8 National foreword This British Standard is the official English language version of EN ISO 1135-4:2004.
3、 It is identical with ISO 1135-4:2004. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, 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
4、 which implement international or European publications referred 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 pub
5、lication does not purport to include all the necessary provisions 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 internati
6、onal/European committee any enquiries on the interpretation, or 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 ISO t
7、itle page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 16, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licen
8、sed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1135-4 July 2004 ICS 11.040.20 English version Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:20
9、04) Matriel de transfusion usage mdical - Partie 4: Appareils de transfusion non rutilisables (ISO 1135- 4:2004) Transfusionsgerte zur medizinischen Verwendung - Teil 4: Transfusionsgerte zur einmaligen Verwendung (ISO 1135- 4:2004) This European Standard was approved by CEN on 22 June 2004. CEN mem
10、bers are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on applicat
11、ion to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the
12、same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia
13、, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CENAll rights of exploitation in any form and by any means reserved worldwide fo
14、r CEN national Members. Ref. No. EN ISO 1135-4:2004: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI I NESO 11-53:42( 400E) 2 Foreword This document (EN ISO 1135-4:2004) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infu
15、sion and injection equipment for medical and pharmaceutical use“ in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices“, 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
16、text or by endorsement, at the latest by January 2005, and conflicting national standards shall be withdrawn at the latest by January 2005. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard
17、: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The tex
18、t of ISO 1135-4:2004 has been approved by CEN as EN ISO 1135-4:2004 without any modifications. EN ISO 11354:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 1135-4 Third edition 2004-07-15 Reference number ISO
19、1135-4:2004(E) OSI 2004 Transfusion equipment for medical use Part 4: Transfusion sets for single use Matriel de transfusion usage mdical Partie 4: Appareils de transfusion non rutilisables EN ISO 11354:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:17 GMT+00:00 2006, Uncontrolled
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24、rtie mohI reSO ta the asserdd ebwol or ISOmem sreb obyd t nitnuoc ehry fo teh euqertsre. SIc Oopyrigho tfifce saCsop etela 65 -HCG 1121eneva 02 T.le 22 14 + 10 947 11 Fxa + 22 14 0 94774 9 Eam-il ocpyrithgios.ogr Web wwwi.soo.rg 4002:45311 OSI NEEN ISO 11354:2004 Licensed Copy: sheffieldun sheffield
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