ÖNORM EN ISO 14155:2024 07 15
Current
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Hardcopy
German - English
11-15-2021
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
New child AMD 11 2025 is added
|
| DocumentType |
Standard
|
| Pages |
123
|
| ProductNote |
New child AMD 11 2025 is added
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 14155:2020 | Identical |
| EN ISO 14155:2020 | Identical |
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