ÖNORM EN ISO 20916:2024 08 01
Current
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Clinical performance studies on human test material - Good study practice (ISO 20916:2019)
Available format(s)
Hardcopy
Language(s)
German - English
Published date
01-08-2024
Important note : Users cannot be edited or removed once added to your Multi user PDF.This document establishes good study practice for the planning, design, conduct, recording, and reporting of clinical performance studies conducted to evaluate the clinical performance and safety of in vitro diagnostic medical devices (IVDs) for regulatory purposes.
| Committee |
ISO/TC 212
|
| DocumentType |
Standard
|
| Pages |
82
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 20916:2024 | Identical |
| ISO 20916:2019 | Identical |
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