EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfung im Rahmen eines Risikomanagementverfahrens (ISO 10993-1:2009)
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices