Project

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

Abstract

The scope of ISO 20916 is a good study practice which addresses the planning, design, conduct, recording and reporting of clinical performance studies for in vitro diagnostic medical devices (IVD). It provides recommendations on documentation and auditing to ensure the study's management compliance. The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. 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.

Begin

2019-12-20

WI

00140146

Planned document number

DIN EN ISO 20916

Project number

06302002

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  

draft standard

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
2021-05
Order from Beuth Verlag

Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

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

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