SS ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice
OVERVIEW
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.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2020 |
| No. of Pages | 102 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 14155 : 2020 IDT |