BSENIS07405:2018 BSlStandardsPublication Dentistry - Evaluation of biocompatibility of medical devices used in dentistry bsi. BSENIS07405:2018 BRITISH STANDARD National foreword This British Standard is the UK implementation of ENIS07405:2018.It supersedesBSENIS07405:2008+A1:2013,whichiswithdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/106, Dentistry. A list of organizationsrepresented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions ofa contract.Users areresponsiblefor its correctapplication. @TheBritish StandardsInstitution2018 Published byBSI Standards Limited 2018 ISBN9780580947124 ICS11.060.10;11.100.99;11.100.20 Compliance with a British Standard cannot confer immunityfrom legal obligations. This British Standard was published under the authority of the StandardsPolicyandStrategyCommitteeon30November2018 Amendments/corrigendaissuedsincepublication Date Text affected EN IS0 7405 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHENORM November 2018 ICS11.060.10;11.100.99 Supersedes EN IS0 7405:2008, 1, Version correct as of 29/11/2018 EnglishVersion Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (IS0 7405:2018) Medecine bucco-dentaire- Evaluation de la Zahnheilkunde-Beurteilung der Biokompatibilitat biocompatibilité des dispositifs medicauxutilisés von in der Zahnheilkunde verwendeten enmédecinebucco-dentaire (IS07405:2018) Medizinprodukten (IS07405:2018) This European Standard wasapprovedby CEN on17August2018. 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 referencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentre 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 theresponsibility ofa CEN member into its own language and notifiedto the CEN-CENELEC ManagementCentrehasthesamestatusastheofficialversions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark Estonia,Finland,Former Yugoslav Republic 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 COMITEEUROPEEN DE NORMALISATION EUROPAISCHES KOMITEEFURNORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018CEN All rights of exploitation in any form and by any means reserved Ref.No.EN IS0 7405:2018: E worldwidefor CEN national Members