BS-EN-ISO-8536-11-2004.pdf
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1、BRITISH STANDARD BS EN ISO 8536-11:2004 Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipment The European Standard EN ISO 8536-11:2004 has the status of a British Standard ICS 11.040.20 ? Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:48
2、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8536-11:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 21 December 2004 BSI 21 December 2004 ISBN 0 580 45135 6 National foreword This British Standard is the official English langua
3、ge version of EN ISO 8536-11:2004. It is identical with ISO 8536-11:2004. 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. Cro
4、ss-references The British Standards 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
5、 British Standards Online. This publication 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; p
6、resent to the responsible international/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,
7、an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 8, 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. N
8、o. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-11 December 2004 ICS 11.040.20 English version Infusion equipment for medical use - Part 11: Infusion filters for u
9、se with pressure infusion equipment (ISO 8536-11:2004) Matriel de perfusion usage mdical - Partie 11: Filtres de perfusion pour utilisation avec des appareils de perfusion sous pression (ISO 8536-11:2004) This European Standard was approved by CEN on 30 September 2004. CEN members are bound to compl
10、y 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 application to the Central Secr
11、etariat 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 same status as the offi
12、cial 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, Slovenia, Spain, Swed
13、en, 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 for CEN national Members.
14、 Ref. No. EN ISO 8536-11:2004: E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI NE ISO 58( 4002:11-63E) 2 Foreword This document (EN ISO 8536-11:2004) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection e
15、quipment 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 text or by endorseme
16、nt, at the latest by June 2005, and conflicting national standards shall be withdrawn at the latest by June 2005. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus
17、, 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 text of ISO 8536-11:2004 has
18、been approved by CEN as EN ISO 8536-11:2004 without any modifications. EN ISO 853611:2004 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 8536-11 First edition 2004-10-01 Reference number ISO 8536-11:2004(E) OSI 20
19、04 Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipment Matriel de perfusion usage mdical Partie 11: Filtres de perfusion pour utilisation avec des appareils de perfusion sous pression EN ISO 853611:2004 Licensed Copy: sheffieldun sheffieldun, na, Thu
20、 Nov 16 06:44:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -6358:11)E(4002 ii ISO 4002 All rithgs reresvde id FDPscalimer ThFDP si fam eliy ctnome niat deddebyepfa.sec In cacnadrociw eth sebodA sneciliycilop gn, thf siam elirp eb ytnide or viewb detu llahs ton tide ebed lnuet sst ehyfepcaa hcih
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