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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001: Difference between revisions

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|has_document=Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
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A.6.3
A.6.3
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|tags_display=[[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]]
 
|comment=Repeated entry: 3.2.2 ++ 5.4.1
{{:Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020}}
 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 3 — Unit 3.2.2
|-
! Scope
| MD
|-
! Document part
| Annex A
A.6.3
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[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]]
|-
! Comment
| Repeated entry: 3.2.2 ++ 5.4.1


Protocol content: subject selection criteria and withdrawal
Protocol content: subject selection criteria and withdrawal
|}
|content=A.6.3 Subjects
 
== Content ==
A.6.3 Subjects
a) Inclusion […]
a) Inclusion […]
}}

Revision as of 12:55, 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 3.2.2
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

Content

A.6.3 Subjects a) Inclusion […]

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