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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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{{#set:
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|HasDocument=Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
|has_document=Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
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|RefDocPart=5.8.4 - 5.8.6
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|tags=TAG-00031-Pat-onA ++ TAG-00149-Sig-nds ++ TAG-00029-Inf-rte ++ TAG-00062-Med-tre
{{:Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020}}
|tags_display=[[Glossary:TAG-00031-Pat-onA|Patient information sheet]], [[Glossary:TAG-00149-Sig-nds|Signature]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00062-Med-tre|Medical care]]
 
|comment=Information provided to subjects and consent signature
{| class="wikitable gplx-infobox"
|content=5.8.4 Information to be provided to the subject
|-
! colspan="2" class="gplx-infobox-header" | 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
| [[Glossary:TAG-00031-Pat-onA|Patient information sheet]], [[Glossary:TAG-00149-Sig-nds|Signature]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00062-Med-tre|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
5.8.5 Informed consent signature
Line 47: Line 17:
5.8.6 New information
5.8.6 New information
[…]
[…]
}}

Latest revision as of 13:49, 16 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

Content

5.8.4 Information to be provided to the subject [...] 5.8.5 Informed consent signature [...] 5.8.6 New information […]

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