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Draft standard

DIN EN ISO 20916
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021

Title (German)

In-vitro-Diagnostika - Klinische Leistungsuntersuchungen an menschlichem Untersuchungsmaterial - Gute Studienpraxis (ISO 20916:2019); Deutsche und Englische Fassung prEN ISO 20916:2021

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 2021-05
Original language German , English
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Table of contents

Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

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