BS EN ISO 8362-4:2011 BSl Standards Publication Injection containers and accessories Part 4: Injection vials made of moulded glass (ISO 8362-4:2011) bsi. ..making excellence a habit: BRITISH STANDARD BS EN ISO 8362-4:2011 Nationalforeword This British Standard is the UK implementation of EN ISO 8362-4:2011.It supersedes BS EN ISO 8362-4:2004 which is withdrawn.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 ISBN9780580737909 ICS 11.040.20 Compliancewitha British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Amendments issued sincepublication Date Text affected EUROPEANSTANDARD EN ISO 8362-4 NORMEEUROPEENNE EUROPAISCHENORM September 2011 ICS 11.040.20 Supersedes EN ISO 8362-4:2004 English Version Injectioncontainersandaccessories-Part4:Injectionvials madeof moulded glass (lSO8362-4:2011) Recipients et accessoires pour produits injectables -Partie Injektionsbehaltnisse und Zubehor -Teil 4: 4: Flacons en verre moule (ISO 8362-4:2011) Injektionsflaschen aus Huttenglas (ISO 8362-4:2011) This European Standard was approved by CEN on 31 August 2011. CEN members are bound to comply with the CEN/CENELEC Intermal 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 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 COMITEEUROPEEN DENORMALISATION EUROPAISCHES KOMITEEFUR NORMUNG Management Centre:AvenueMarnix 17,B-1000 Brussels 2011CEN All rights of exploitation in any form and by any means reserved Ref.No.EN ISO 8362-4:2011: E worldwide for CEN national Members. BS EN ISO 8362-4:2011 ENISO 8362-4:2011 (E) Foreword This document (EN ISO 8362-4:2011) 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 8362-4:2004 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 BS ENISO 8362-4:2011 ISO8362-4:2011(E) Foreword ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies non-governmental, in liaison with isO,also take part in the work. sO collaborates closely with the Intern