BS EN ISO 8536-8:2015 BSl Standards Publication Licensed copy:IPLogin,Universityof Oxford,Versioncorrectasof Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus bsi. ..making excellence a habit. BSENISO8536-8:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 8536-8:2015. It supersedes BS EN ISO 8536-8:2004 which is withdrawn.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. @ The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN9780580832765 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 Policy and Strategy Committee on 30 June 2015. Amendments issued sincepublication Date Text affected ENISO8536-8 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHENORM June2015 ICS11.040.20 Supersedes EN ISO 8536-8:2004 English Version ,Versioncorrectasof02/05/2016 Infusionequipmentformedicaluse -Part 8: Infusion sets for single usewithpressure infusion apparatus (lsO 8536-8:2015) Materiel de perfusion a usage medical - Partie 8: Appareils Infusionsgerate zur medizinischen Verwendung - Teil 8: de perfusion non reutilisables avec des appareilis de Infusionsgerate zur einmaligen Verwendung mit perfusion sous pression (ISO 8536-8:2015) Druckinfusionsapparaten (ISO 8536-8:2015) 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 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 Licensed copy: IP Login, University of Oxford, status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Siovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEEFOR STANDARDIZATION COMITE EUROPEEN DENORMALISATION EUROPAISCHES KOMITEEFURNORMUNG CEN-CENELECManagementCentre:AvenueMarnix17,B-1000Brussels @2015CEN All rights of exploitation in any form and by any means reserved Ref.No.ENISO 8536-8:2015E worldwide for CEN national Members. BSENISO8536-8:2015 ENISO8536-8:2015 (E) European foreword infusion and injection, and blood processing equipment for medical and pharmaceutical use" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical Licensed copy:IP Login, Universityof Oxford, Version correct as of 02/05/2016 atthelatestbyDecember2015. 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 supersedesEN ISO8536-8:2004. In this edition the following changes have been made: the part title has been changed from 'Infusion equipment ...'to 'Infusion sets ...'; theformerClause 4on designationhasbeen deleted; 6.14 has been amended and an appropriate Annex B'Storage volume'added; Clause 10 on labelling was amended by a note regarding the usage of the sy