BS EN ISO 8536-1:2011 BSl Standards Publication Infusion equipment for medical use Part 1: Infusion glass bottles (ISO 8536-1:2011) bsi. ..making excellence a habit BRITISH STANDARD BS EN ISO 8536-1:2011 Nationalforeword This British Standard is the UK implementation of EN ISO 8536-1:2011. It supersedes BS EN IS0 8536-1:2008 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212,IVDs. A list of organizations represented on this committee 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. @BSI 2011 ISBN9780580706882 ICS 11.040.20 Compliancewitha British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policyand Strategy Committee on 30 September 2011. Amendments issued since publication Date Text affected EUROPEANSTANDARD EN ISO 8536-1 NORMEEUROPEENNE EUROPAISCHENORM September 2011 ICS11.040.20 Supersedes ENISO 8536-1:2008 English Version Infusion equipment for medical use -Part 1:Infusionglass bottles (ISO 8536-1:2011) Materiel de perfusion a usage medical -Partie 1: Flacons Infusionsgerate zur medizinischen Verwendung - Teil 1: en verre pour perfusion (ISO 8536-1:2011) InfusionsflaschenausGlas(ISO8536-1:2011) This European Standard was approved by CEN on 31 August 2011. 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 CEN-CENELEC 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 notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG Management Centre:AvenueMarnix17,B-100oBrussels 2011CEN All rights of exploitation in any form and by any means reserved Ref. No.EN ISO 8536-1:2011: E worldwide for CEN national Members. BS EN ISO 8536-1:2011 ENISO 8536-1:2011 (E) Foreword This document (EN ISO 8536-1:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use". 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 March 2012, and conflicting national standards shall be withdrawn at the latest by March 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-1:2008 According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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,SwitzerlandandtheUnitedKingdom Endorsementnotice The text of ISO 8536-1:2011 has been approved by CEN as a EN ISO 8536-1:2011 without any modif