BS EN ISO BRITISH STANDARD 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods The European Standard ENIS0 8871-4:2006 has the status of a BritishStandard ICS 11.040.20 BSi NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards BSENISO8871-4:2006 National foreword This British Standard was published by BSI. It 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 provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was Amendmentsissuedsincepublication published under the authority of the Standards Policy and Date Amd. No. Comments Strategy Committee on 29 September 2006 BSI 2006 ISBN058049229X EUROPEANSTANDARD ENISO 8871-4 NORMEEUROPEENNE EUROPAISCHENORM June 2006 ICS 11.040.20 Supersedes ENISO 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) Elements en elastomere pour administration parenterale et Elastomere Teile fur Parenteralia und fur Gerate zur dispositifs a usage pharmaceutique - Partie 4: Exigences pharmazeutischen Verwendung - Teil 4: Biologische biologiques et methodes d'essais (ISO 8871-4:2006) Anforderungen und Prufverfahren (ISO 8871-4:2006) This 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 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 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. cer EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEENDE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG Management Centre:rue deStassart, 36 B-1050 Brussels @2006CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-4:2006: E worldwide for CEN national Members. ENISO 8871-4:2006 Foreword This document (EN ISO 8871-4:2006) has been prepared by Technical CommitteeISO/TC 76"Transfusion infusion and injection equipment formedical and pharmaceutical use" in collaboration with CMC This European Standard shall be given the status of a national standard, either by publication of an identical at the latest by December 2006. This document supersedes ENISO 8871:1997. 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, Czech Republic Switzerland and United Kingdom. Endorsementnotice ThetextofISO8871-4:2006hasbeenapproved byCENas EN ISO8871-4:2006without any modifications EN ISO 8871-4:2006 ISO INTERNATIONAL STANDARD 8871-4 First edition 2006-06-15 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods Elements en élastomere pour administrat