BS-EN-ISO-8536-1-2003.pdf
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1、BRITISH STANDARD BS EN ISO 8536-1:2003 Infusion equipment for medical use Part 1: Infusion glass bottles The European Standard EN ISO 8536-1:2003 has the status of a British Standard ICS 11.040.20 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c
2、) BSI BS EN ISO 8536-1:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 9 June 2003 BSI 9 June 2003 ISBN 0 580 41981 9 National foreword This British Standard is the official English language version of EN ISO 8536-1:2003. It is identical
3、 with ISO 8536-1:2000. It supersedes BS EN ISO 8536-1:1999 which is withdrawn. 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
4、. Cross-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
5、or of 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 te
6、xt; present 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 co
7、ver, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 5, the Annex ZA page, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendme
8、nts issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-1 May 2003 ICS 11.040.20Supersedes EN ISO 8536-1:1999 English version Infusion e
9、quipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2000) Matriel de perfusion usage mdical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2000) Infusionsgerte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2000) This European Standard was ap
10、proved by CEN on 27 December 2002. CEN members 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 nati
11、onal 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 version in any other language made by translation under the responsibility of a CEN member into its own language and noti
12、fied 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spai
13、n, 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 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national M
14、embers. Ref. No. EN ISO 8536-1:2003 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of ISO 8536-1:2000 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and phar
15、maceutical use“ of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8536- 1:2003 by CMC. 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 November 2003, an
16、d conflicting national standards shall be withdrawn at the latest by November 2003. This document supersedes EN ISO 8536-1:1999. For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the nationa
17、l standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland an
18、d the United Kingdom. Endorsement notice The text of ISO 8536-1:2000 has been approved by CEN as EN ISO 8536-1:2003 without any modifications. EN ISO 85361:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 8536-1:2000
19、(E) INTERNATIONAL STANDARD ISO 8536-1 Second edition 2000-06-15 Infusion equipment for medical use Part 1: Infusion glass bottles Matriel de perfusion usage mdical Partie 1: Flacons en verre pour perfusion EN ISO 85361:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 20
20、06, Uncontrolled Copy, (c) BSI ii EN ISO 85361:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .1 4Dimensions and designation2 5Material
21、.4 6Performance.5 7Requirements.5 8Marking .5 EN ISO 85361:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
22、member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, govern
23、mental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Di
24、rectives, Part 3. Draft International Standards adopted by the 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
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