ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible international committee
ISO/TC 194/WG 1 - Systematic approach to biological evaluation and terminology