• Hydrogen Technologies Standards form the basic framework for market ramp-up

    More information

  • Climate change Standards and specifications support climate targets

    More information

  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

    More information
 
Standards [CURRENT]

DIN EN ISO 20916
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024

Title (German)

In-vitro-Diagnostika - Klinische Leistungsstudien unter Verwendung von menschlichem Untersuchungsmaterial - Gute Studienpraxis (ISO 20916:2019); Deutsche Fassung EN ISO 20916:2024

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices  

Responsible international committee

ISO/TC 212/WG 3 - In vitro diagnostic products  

Edition 2024-07
Original language German
Translation English
Price from 175.20 €
Order from DIN Media
Table of contents

Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2404
Fax: +49 30 2601-42404

Send message to contact