NEN-ISO 20916:2019
Current
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
Available format(s)
Hardcopy
Language(s)
English
Published date
01-06-2019
Publisher
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NEN-ISO 20916 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 |
0
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| ISO 20916:2019 | Identical |
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