DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025); German version EN ISO 10993-1:2025
Biologische Beurteilung von Medizinprodukten - Teil 1: Anforderungen und allgemeine Grundsätze für die Beurteilung der biologischen Sicherheit im Rahmen eines Risikomanagementsystems (ISO 10993-1:2025); Deutsche Fassung EN ISO 10993-1:2025
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
Responsible international committee
ISO/TC 194/WG 1 - Systematic approach to biological evaluation and terminology
