UNI EN ISO 20916:2024
Current
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
Published date
30-05-2024
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This document defines good study practice for clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 20916:2019 | Identical |
| EN ISO 20916:2024 | Identical |
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