$159
AAMI/ISO 14155:2020
2020
Clinical investigation of medical devices for human subjects – Good clinical practice
- Format:
- Language(s) :
- Published :
- English
- 12/07/2020
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 can be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to:
- protect the rights, safety and well-being of human subjects;
- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results;
- define the responsibilities of the sponsor and principal investigator, and;
- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
| AAMI/ISO 14155:2020 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | AAMI/ISO 14155:2020 |
| Scope | Clinical investigation of medical devices for human subjects - Good clinical practice |
| Publisher | AAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization |
| Languages | English |
| State | |
| Publication Year | 2020 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| ANSI | ANSI Approved |
| Edition | 9781570207815 |
| File Size | 1 file , 1.1 MB |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 88 |
| Published | 12/07/2020 |
| AAMI/ISO 14155:2020 | ||
|---|---|---|
| History | Publisher Year | |
| AAMI/ISO 14155:2020 | 2020 | Current |
| AAMI/ISO 14155:2011 | 2011 | |
| AAMI/ISO 14155-2:2003/(R)2008 | 2008 | |
| AAMI/ISO 14155-1:2003/(R)2008 | 2008 |
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