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
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