BSl Standards Publication Infusion equipment for medical Use University Library,eriot-latt Version oorrec Part 10:Accessories for fluid lines for single use with pressure infusion equipment Licensed copy: Heriot- Watt, H bsi. ..making excellence a habit. BSEN ISO 8536-10:2015 BRITISHSTANDARD Nationalforeword This British Standard is the UK implementation of EN ISO 8536-10:2015.It supersedes BS EN ISO 8536-10:2004 which is withdrawn.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 ISBN9780580832949 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 EN ISO 8536-10 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM June 2015 ICS 11.040.20 Supersedes EN ISO 8536-10:2004 English Version Infusion equipment for medical use -Part 10:Accessories for fluid lines for single use with pressure infusion equipment (IsO 8536-10:2015) Materiel de perfusion a usage medical -Partie 10: Infusionsgerate zur medizinischen Verwendung-Teil 10: Accessoires pour tubulures non reutilisables avec un Zubehorteile fur Obertragungsleitungenzur einmaligen materiel de perfusion sous pression (ISO 8536-10:2015) Verwendung mit Druckinfusionsapparaten(ISO 8536- 10:2015) This European Standard was approved by CEN on 16 April 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions forgiving this European Standard the statusof 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 anyCEN member. This European Standard exists in three offcial 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,FormerYugoslav Republic of,Macedonia,France,Germany,Greece,Hungary,iceland,Ireland,taly,Latvia,Lithuania, Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,Turkey and United Kingdom ces EUROPEAN COMMITTEEFOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FOR NORMUNG CEN-CENELEC Management Centre:Avenue Marnix 17,B-1000 Brussels Ref.No.EN ISO 8536-10:2015E worldwide for CEN national Members. BS EN ISO 8536-10:2015 ENISO8536-10:2015(E) European foreword This document (EN ISO 8536-10:2015)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 8536-10:2004. In this edition the following changes have been made: —the former Clause 3 on designation has been deleted; ISO 7000-2725; Clause 9 on disposal has been added; A.4'Tests for leakage'has been amended; deleted; -Normative references and the 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 Re