BS-EN-ISO-8536-1-1999.pdf
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1、BRITISH STANDARD BS EN ISO 8536-1:1999 Infusion equipment for medical use Part 1: Infusion glass bottles The European Standard EN ISO 8536-1:1999 has the status of a British Standard ICS 11.040.20 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, Uncontrolled Copy, (c)
2、BSI BS EN ISO 8536-1:1999 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 August 1999 BSI 03-2000 ISBN 0 580 32182 7 National foreword This British
3、 Standard is the English language version of EN ISO 8536-1:1999, including corrigendum May 1999. It is identical with ISO 8536-1:1991. The UK participation in its preparation was entrusted to Technical Committee CH/11, Transfusion equipment for medical use, which has the responsibility to: aid enqui
4、rers to understand the text; 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. A list of organizations re
5、presented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British
6、 Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purpor
7、t to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cov
8、er, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 3 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issu
9、ed since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8536-1:1999 BSI 03-2000i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of ISO 8536-11 Licensed Copy: sheffield
10、un sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-1 February 1999 ICS 11.040.00Incorporat
11、es Corrigendum May 1999 English version Infusion equipment for medical use Part 1: Infusion glass bottles (ISO 8536-1:1991) Matriel de perfusion usage mdical Partie 1: Flacons en verre pour perfusion (ISO 8536-1:1991) Infusionsgerte zur medizinischen Verwendung Teil 1: Infusionsflaschen aus Glas (IS
12、O 8536-1:1991) This European Standard was approved by CEN on 9 January 1999. 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 bibli
13、ographical references concerning such national standards may be obtained on application 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
14、 a CEN member into its own language and notified to the Central Secretariat 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, Iceland, Ireland, Italy, Luxembourg, Netherlands, No
15、rway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved w
16、orldwide for CEN national Members. Ref. No. EN ISO 8536-1:1999 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8536-1:1999 BSI 03-2000 2 Foreword The text of the International Standard from Technical Committee ISO/TC 76 “Transfusion
17、, infusion and injection equipment for medical use” of the International Organization for Standardization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC “Non-active medical devices”, the secretariat of which is held by BSI. This European Standard shall be given the s
18、tatus of a national standard, either by publication of an identical text or by endorsement, at the latest by August 1999, and conflicting national standards shall be withdrawn at the latest by August 1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
19、 following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the I
20、nternational Standard ISO 8536-1:1999 has been approved by CEN as a European Standard without any modification. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, U
21、ncontrolled Copy, (c) BSI EN ISO 8536-1:1999 ii BSI 03-2000 Contents Page Forewordiii Introduction1 1Scope1 2Normative references1 3Definitions1 4Dimensions and designation1 5Material1 6Performance1 7Requirements3 8Marking3 Figure 1 Infusion glass bottle with two typical neck finishes2 Table 1 Dimen
22、sions and capacity of infusion bottle3 Descriptors: Medical equipment, parenteral infusion equipment, containers, glass, flasks, specifications, dimensions, designation, marking. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8536-1:
23、1999 BSI 03-2000iii Foreword 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 interested in a s
24、ubject 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 Electrotechnical Commission
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