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NA 027

DIN Standards Committee Optics and Precision Mechanics

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Draft standard [Withdrawn]

DIN 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/DAM 1:2021); German and English version EN ISO 10993-18:2020/prA1:2021

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/DAM 1:2021); Deutsche und Englische Fassung EN ISO 10993-18:2020/prA1:2021

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 14 - Material characterization  

Edition 2021-10
Original language German , English
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