NF EN ISO 20916:2024
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
06-03-2024
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice 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 |
ISO/TC 212
|
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 20916:2019 | Identical |
| EN ISO 20916:2024 | Identical |
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