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NF ISO 20916:2019

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

Available format(s)

Hardcopy

Superseded date

04-04-2024

Superseded by

NF EN ISO 20916:2024

Language(s)

English - French

Published date

01-09-2019

€223.18
Excluding VAT

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.

Committee
TC 212
DocumentType
Standard
Pages
66
PublisherName
Association Francaise de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
ISO 20916:2019 Identical

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