BS-EN-ISO-8871-4-2006.pdf
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1、BRITISH STANDARD BS EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods The European Standard EN ISO 8871-4:2006 has the status of a British Standard ICS 11.040.20 ? Licensed Copy: sheffieldun sheffieldun, na, F
2、ri Nov 17 15:07:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8871-4:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 September 2006 BSI 2006 ISBN 0 580 49229 X National foreword This British Standard was published by BSI. It
3、 is the UK implementation of EN ISO 8871-4:2006. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A list of organizations represented on CH/212 can be obtained on request to its secretary. This publication does not purport to include all the necessary provis
4、ions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:02 GMT+00:00 2006, Uncontrol
5、led Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8871-4 June 2006 ICS 11.040.20Supersedes EN ISO 8871:1997 English Version Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006) lments en
6、 lastomre pour administration parentrale et dispositifs usage pharmaceutique - Partie 4: Exigences biologiques et mthodes dessais (ISO 8871-4:2006) Elastomere Teile fr Parenteralia und fr Gerte zur pharmazeutischen Verwendung - Teil 4: Biologische Anforderungen und Prfverfahren (ISO 8871-4:2006) Thi
7、s European Standard was approved by CEN on 5 June 2006. 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
8、 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 a CEN member into it
9、s 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lux
10、embourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, 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 2006 CENAll r
11、ights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8871-4:2006: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document supersedes EN ISO 8871:1997. According to t
12、he CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerl
13、and and United Kingdom. Endorsement notice This document (EN ISO 8871-4:2006) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“ in collaboration with CMC. This European Standard shall be given the status of a nationa
14、l standard, either by publication of an identical text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, The
15、 text of ISO 8871-4:2006 has been approved by CEN as EN ISO 8871-4:2006 without any modifications. EN ISO 8871-4:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 8871-4:2006(E) INTERNATIONAL STANDARD ISO 8871-4 First
16、 edition 2006-06-15 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods lments en lastomre pour administration parentrale et dispositifs usage pharmaceutique Partie 4: Exigences biologiques et mthodes dessai EN ISO 8871-4:2006 Lic
17、ensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organization for Standardization) is a worldwide f
18、ederation 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 subject for which a technical committee has been established has the right to be represented on that co
19、mmittee. International organizations, governmental 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 accor
20、dance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requir
21、es approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8871-4 was prepared by Technica
22、l Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This first edition, together with parts 1, 2, 3 and 5, cancels and replaces ISO 8871:1990 and ISO 8871:1990/Amd.1:1995, which has been technically revised. ISO 8871 consists of the following part
23、s, under the general title Elastomeric parts for parenterals and for devices for pharmaceutical use: Part 1: Extractables in aqueous autoclavates Part 2: Identification and characterization Part 3: Determination of released-particle count Part 4: Biological requirements and test methods Part 5: Func
24、tional requirements and testing EN ISO 8871-4:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Introduction The pharmaceutical industry requires, to an increasing extent, concrete details from the rubber manufacturer about the biologi
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