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
In-vitro-Diagnostika - Klinische Leistungsstudien unter Verwendung von menschlichem Untersuchungsmaterial - Gute Studienpraxis (ISO 20916:2019); Deutsche Fassung EN ISO 20916:2024
Overview
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. This document is specific for IVD medical devices and therefore uses definitions and concepts that are appropriate for IVD medical devices. This document identifies the principles that underpin clinical performance studies and specifies general requirements. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems" and adopted by Technical Committee CEN/TC 140 "In vitro diagnostic systems" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Quality management in medical laboratories" at DIN Standards Committee Medicine (NAMed) is responsible for this standard.
Document: references other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
