EUROPEAN STANDARD EN ISO 10993-1 NORME EUROPEENNE EUROPAISCHE NORM December 2020 is11.100.20 Supersedes EN ISO 10993-1 :2009 English Version Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process ( ISO10993-1 :2018 ,including corrected version 2018-11 ) Evaluation biologique des dispositifs medicaux Partie Biologische Beurteilung von Medizinprodukten Teil 1 : 1 :Evaluation et essais au sein d'un processus de Beurteilung und Prufungen im Rahmen eines gestion du risque ( 10993-1 :2018 ,y pris Risikomanagementsystems ( 10993-1 :2018 , version corrigee 2018-11 ) einschlieBlich korrigierte Fassung 2018-11 ) This European Standard was approved by CEN on 10 December 2020 . CEN members are bound to ply with the CEN /CENELECInternal 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 ...
EN ISO 10993-1-2020 Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process.pdf
