• Hydrogen Technologies Standards form the basic framework for market ramp-up

    More information
  • Climate change Standards and specifications support climate targets

    More information
  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

    More information
Standards [CURRENT]

EN ISO 10993-18/A1
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)

Title (German)

Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems - Änderung 1: Bestimmung des Unsicherheitsfaktors (ISO 10993-18:2020/Amd 1:2022)

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Edition 2023-07
Original language English
Price On Request
Table of contents