BSENIS010993-4:2017 BSI Standards Publication Biological evaluation of medical devices Part4:Selectionoftestsforinteractionswithblood bsi. BritishStandards ATION9972181 BRITISH STANDARD BSENIS010993-4:2017 National foreword ThisBritishStandardistheUKimplementationofENIS010993-4:2017 It supersedes BS EN IS0 10993-4:2009, which is withdrawn. TheUKparticipation in its preparationwas entrusted toTechnical CommitteeCH/194,Biologicalevaluationofmedicaldevices. A list of organizationsrepresented on this committee canbeobtained on requestto its secretary. This publication does not purportto include all the necessaryprovisions ofacontract.Users areresponsibleforits correctapplication. TheBritishStandardsInstitution2017 PublishedbyBSIStandardsLimited2017 ISBN9780580844577 ICS11.100.20 Compliancewitha British Standard cannotconferimmunityfrom legal obligations. ThisBritishStandardwaspublished undertheauthorityof the Amendments/corrigendaissuedsincepublication Date Text affected British Standards Instition Licensee=SHENZHEN ACADEMY OF STANDARDIZATION 9972181 Not for Resale, 2017/8/17 04:42:13 fromIH EUROPEANSTANDARD ENIS010993-4 NORMEEUROPEENNE EUROPAISCHENORM May2017 ICS11.100.20 Supersedes EN IS010993-4:2009 EnglishVersion Biological evaluation ofmedical devices-Part 4: Selection of tests for interactions with blood (IsO 10993-4:2017) Evaluation biologique des dispositifs BiologischeBeurteilungvon Medizinprodukten- medicaux-Partie 4:Choix des essais pour les Teil 4:AuswahlvonPrufungen zur interactions avecle sang (Is010993-4:2017) Wechselwirkung mitBlut (IS010993-4:2017) ThisEuropeanStandardwasapprovedbyCENon23February2017. CEN members are bound to comply withthe CEN/CENELEC Internal Regulations which stipulate theconditionsfor giving this European Standard the status of a national standard without any alteration.Up-to-date lists and bibliographical references concerningsuchnationalstandardsmaybeobtained onapplicationtotheCEN-CENELECManagement Centre ortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguage Management Centre has thesamestatus astheofficial versions. CENmembers arethenational standards bodies of Austria,Belgium,Bulgaria,Croatia,Cyprus,Czech Republic,Denmark, Estonia, Finland,Former YugoslavRepublic of Macedonia,France,Germany,Greece,Hungary,Iceland, Ireland,Italy, Latvia, Lithuania, Luxembourg,Malta, Netherlands, Norway, Poland, Portugal,Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,Switzerland,TurkeyandUnitedKingdom cen EUROPEANCOMMITTEEFORSTANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEEFUR NORMUNG CEN-CENELECManagementCentre:AvenueMarnix17,B-1000Brussels 2017CEN All rights of exploitation in any form and by any means reserved Ref.No.ENIS010993-4:2017:E worldwide for CEN national Members British Standards Institution censee=SHENZHEN ACADEMY OF STANDARDIZATION 9972181 Not for Resale, 2017/8/17 04:42:13 fromIH