SS ISO 14155:2026
Clinical investigation of medical devices for human subjects – Good clinical practice
OVERVIEW
This standard specifies good clinical practice (GCP) 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. For post-market clinical investigations, the principles set forth in this standard are intended to be followed as far as relevant, considering the nature of the clinical investigation.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2026 |
| No. of Pages | 97 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 14155 : 2026 IDT |