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Draft standard [New]

DIN EN ISO 18969
Clinical evaluation of medical devices (ISO/DIS 18969:2025); German and English version prEN ISO 18969:2025

Title (German)

Klinische Bewertung von Medizinprodukten (ISO/DIS 18969:2025); Deutsche und Englische Fassung prEN ISO 18969:2025

Responsible national committee

NA 027-07-20-01 AK - Clinical Evaluation  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 4 - Clinical investigation and evaluation of medical devices in humans  

Edition 2026-01
Publication 2025-11-28
Public enquiry period until 2026-01-28
Original language German , English
Price from 139.20 €
Read draft and comment Order from DIN Media
Table of contents

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Susann Minkwitz

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