BSl Standards Publication Infusion equipment for medical Use Licensed copy: Inperial College, Imperial College London, Version correc Part 11:Infusion filters for single use with pressure infusion equipment bsi. ..making excellence a habit. BS EN ISO 8536-11:2015 BRITISHSTANDARD Nationalforeword This British Standard is the UK implementation of EN ISO 8536-11:2015.It supersedes BS EN ISO 8536-11:2004 which is withdrawn. The UK participation in its preparation was entrusted to Technical CommitteeCH/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. O The British Standards Institution 2015.Published by BSI Standards Limited2015 ISBN9780580832956 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards PolicyandStrategyCommitteeon30June2015 Amendments issuedsincepublication Date Textaffected ENISO8536-11 EUROPEAN JSTANDARD NORME EUROPEENNE EUROPAISCHE NORM June2015 ICS 11.040.20 Supersedes EN ISO 8536-11:2004 English Version Infusionequipmentformedicaluse -Part 11:lnfusionfiltersfor single use with pressure infusion equipment (lSO8536-11:2015) Materiel de perfusion a usage medical -Partie 11:Filtres a Infusionsgerate zur medizinischen Verwendung -Teil 11: perfusion non reutilisables avec un materielde perfusion Infusionsfilterzur einmaligenVerwendungmit sous pression(ISO 8536-11:2015) Druckinfusionsapparaten (ISO 8536-11:2015) This European Standard was approved by CEN on 16 April 2015. CEN members are bound to comply with the CEN/CENELEC Intermal Regulations which stipulate the conditions forgiving this European Standard the status of a national standard without any alteration.Up-to-date ists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to anyCEN member. This European Standard exists in three fficialversions (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. Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,Turkey and United Kingdom. ces EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FORNORMUNG CEN-CENELEC Management Centre:Avenue Marnix 17,B-1000 Brussels Ref.No.EN ISO 8536-11:2015E worldwide for CEN national Members. BS EN ISO 8536-11:2015 ENISO8536-11:2015(E) European foreword This document (EN ISO 8536-11:2015)has been prepared by Technical Committee ISO/TC 76 "Transfusion infusion and injection equipment for medical and pharmaceutical use"in collaboration with Technical Committee CENTC 205 "Non-active medical devices"the secretariat of which is held by DIN. at the latest by December 2015. This document supersedes EN ISO 8536-11:2004. The former Clause 3 on designation has been deleted Clause 9 on labelling was amended by addition of information regarding the usage of the symbol "XXX"accordingISO 7000,symbol 2725; -Clause 10 on disposal has been added; A.4 has been amended; been deleted; -Normative references and Bibliography have been updated; document has been editorially revised. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association,and supports essential requirements of EU Directive(s). 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 Hungary,lceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,