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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002: Difference between revisions

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A.6.3
A.6.3
|RefLanguage=EN
|RefLanguage=EN
|RefTagsEN=
|RefTags=TAG-00033-Pro-oto ++ TAG-00077-Inc-gsk ++ TAG-00078-Exc-ssk ++ TAG-00201-Cli-eSt ++ TAG-00086-Fol-Fol
|RefTagsOriginal=
|RefModule=5
|RefTagsFR=
|RefUnit=5.4.1
}}
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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 5 — Unit 5.4.1
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| [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]], [[Glossary:TAG-00078-Exc-ssk|Exclusion criteria]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00086-Fol-Fol|Follow-up visit]]
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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 5 — Unit 5.4.1
Scope MD
Document part Annex A

A.6.3

Language EN
Original entry by Florian Adragna
Contributors
Tags Protocol, Inclusion criteria, Exclusion criteria, Clinical investigation, Follow-up visit
Comment Repeated entry: 3.2.2 ++ 5.4.1

Protocol content: subject selection and withdrawal criteria (repeated)

Content

A.6.3 Subjects a) Inclusion criteria[…]

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