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NA 027

DIN Standards Committee Optics and Precision Mechanics

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Draft standard [New]

DIN EN ISO 10993-3
Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025

Title (German)

Biologische Beurteilung von Medizinprodukten - Teil 3: Bewertung der Genotoxizität, Karzinogenität, Reproduktionstoxizität und Entwicklungstoxizität (ISO/DIS 10993-3:2025); Deutsche und Englische Fassung prEN ISO 10993-3:2025

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 6 - Mutagenicity, carcinogenicity and reproductive toxicity  

Edition 2025-05
Publication 2025-03-28
Public enquiry period until 2025-05-28
Original language German , English
Price from 145.40 €
Read draft and comment Order from DIN Media
Table of contents

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