SS-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 (ISO 20916:2019, IDT)
Available format(s)
Hardcopy
Language(s)
English
Published date
03-04-2024
Publisher
€305.46
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 |
ISO/TC 212
|
| DocumentType |
Standard
|
| Pages |
76
|
| PublisherName |
Standardiserings-Kommissionen I Sverige
|
| Status |
Current
|
| Standards | Relationship |
| ISO 20916:2019 | Identical |
| EN ISO 20916:2024 | Identical |
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