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
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