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NA 027

DIN Standards Committee Optics and Precision Mechanics

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Draft standard [New]

DIN EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024

Title (German)

Biologische Beurteilung von Medizinprodukten - Teil 1: Anforderungen und allgemeine Grundsätze für die Beurteilung der biologischen Sicherheit im Rahmen eines Risikomanagementsystems (ISO/DIS 10993-1:2024); Deutsche und Englische Fassung prEN ISO 10993-1:2024

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 1 - Systematic approach to biological evaluation and terminology  

Edition 2024-07
Publication 2024-06-21
Public enquiry period until 2024-08-21
Original language German , English
Price from 151.90 €
Read draft and comment Order from DIN Media
Table of contents

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