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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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|RefDocPart=5.8.4 - 5.8.6
|RefDocPart=5.8.4 - 5.8.6
|RefLanguage=EN
|RefLanguage=EN
|RefTagsEN=
|RefTags=TAG-00031-Pat-onA ++ TAG-00149-Sig-nds ++ TAG-00029-Inf-rte ++ TAG-00062-Med-tre
|RefTagsOriginal=
|RefModule=3
|RefTagsFR=
|RefUnit=3.1.4
}}
}}


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! colspan="2" class="gplx-infobox-header" | Reference Details
! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 3 — Unit 3.1.4
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! Scope
! Scope
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! Tags
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| [[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]]
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! Tags (FR)
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! Comment
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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 […]

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