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NA 027

DIN Standards Committee Optics and Precision Mechanics

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Draft standard [New]

DIN EN ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025); German and English version prEN ISO 10993-16:2025

Title (German)

Biologische Beurteilung von Medizinprodukten - Teil 16: Toxikokinetische Beurteilung hinsichtlich Abbauprodukten und herauslösbaren Substanzen (ISO/DIS 10993-16:2025); Deutsche und Englische Fassung prEN ISO 10993-16:2025

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 13 - Toxicokinetics  

Edition 2025-12
Publication 2025-11-21
Public enquiry period until 2026-01-21
Original language German , English
Price from 102.10 €
Read draft and comment Order from DIN Media
Table of contents

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10787 Berlin

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Fax: +49 30 2601-42765

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