DIN EN ISO 20916:2021 Edition

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In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (Draft)

Published By	Publication Date	Number of Pages
DIN	2021-05	154

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Categories: 11.100.10 - In vitro diagnostic test systems, DIN

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Description

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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2021-05
Pages Count	154
Language	Germany
Descriptors	Best practice, Clinical, Clinical investigations, Clinical testing, Definitions, Diagnosis, Ethics, Human body, In vitro, In-vitro diagnostic, Medical examination, Medical sciences, Performance testing, Research, Responsibility, Specimens, Studies, Test materials
File Size	3.5 MB
ICS Codes	11.100.10 - In vitro diagnostic test systems

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DIN EN ISO 20916:2021 Edition

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