Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6: Difference between revisions
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | ISO ISO 14155 -
Clinical investigation of medical devices for human subjects 2020 |
| Validity area | ISO |
| Scope(s) | MD |
| Document name | ISO 14155 -
Clinical investigation of medical devices for human subjects |
| Version / Revision | 2020 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice |
| Official source | Official link |
| Restricted access | Yes |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.4 |
| Scope | MD |
| Document part | 5.8.4 - 5.8.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Patient information sheet, Signature, Informed consent, Medical care |
| Comment | Information provided to subjects and consent signature |
Content
5.8.4 Information to be provided to the subject [...] 5.8.5 Informed consent signature [...] 5.8.6 New information […]
