BSENISO8536-9:2015 BSI Standards Publication Infusion equipmentfor medical use Part 9: Fluid lines for single use with pressure infusion equipment bsi. ..making excellence a habit. BRITISHSTANDARD BSENISO8536-9:2015 National foreword This BritishStandard is the UK implementation of EN ISO 8536-9:2015. It supersedes BS EN ISO 8536-9:2004 which is withdrawn. The UK participation in its preparation was entrusted to Technical CommitteeCH/212,IVDs. A list oforganizations representedon this committee can be obtained onrequestto itssecretary. This publicationdoes not purportto includeall the necessary provisions of a contract. Users are responsible for its correct application. TheBritishStandards Institution2015.PublishedbyBSIStandards Limited2015 ISBN9780580832932 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 StandardsPolicyandStrategyCommitteeon30June2015. Amendments issued sincepublication Date Text affected ENISO8536-9 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHENORM June2015 ICS 11.040.20 SupersedesENiSO8536-9:2004 Licensed copy: Imperial College,Imperial College London, Version correct as of 02/05/2016 English Version Infusion equipment formedical use-Part 9:Fluid lines for single usewithpressureinfusionequipment(is08536-9:2015) Materiel de perfusion a usage medical - Partie 9: Tubulures Infusionsgerate zur medizinischen Verwendung -Teil 9: non reutilisables avec des appareils de perfusion sous Ubertragungsleitungen zur einmaligen Verwendung mit pression (ISO 8536-9:2015) Druckinfusionsapparaten (IsO 8536-9:2015) 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 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, Former Yugoslav Republic of Macedonia, France, Germany,Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,Malta, Netherlands, Norway,Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DENORMALISATION EUROPAISCHES KOMITEEFUR NORMUNG CEN-CENELECManagementCentre:AvenueMarnix17,B-1000Brussels @2015CEN Ref.No.ENISO8536-9:2015E worldwide for CEN national Members. BSENISO8536-9:2015 ENISO8536-9:2015 (E) Europeanforeword This document (ENISO8536-9:2015)hasbeen preparedbyTechnical CommitteeISO/TC76“Transfusion, 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. n,Versioncorrectasof02/05/2016 This European Standard shall be given the status of a national standard, either by publication of an identical 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. Thisdocument supersedes ENISO8536-9:2004 In this edition, the following changes have been made: theformerClause3ondesignationhasbeendeleted; 一 5.8has been amendedand an appropriate AnnexC added; ,Imperial CollegeLondon, accordingISO7000,Symbol2725