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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5: Difference between revisions

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|RefLanguage=EN
|RefLanguage=EN
|RefTagsEN=
|RefTags=TAG-00317-Obj-set ++ TAG-00304-Pri-tSt ++ TAG-00201-Cli-eSt ++ TAG-00077-Inc-gsk
|RefTagsOriginal=
|RefModule=3
|RefTagsFR=
|RefUnit=3.2.2
}}
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! colspan="2" class="gplx-infobox-header" | Reference Details
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| Module 3 — Unit 3.2.2
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| [[Glossary:TAG-00317-Obj-set|Objective]], [[Glossary:TAG-00304-Pri-tSt|Endpoint]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]]
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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 3.2.2
Scope MD
Document part Annex A

A.5

Language EN
Original entry by Florian Adragna
Contributors
Tags Objective, Endpoint, Clinical investigation, Inclusion criteria
Comment Objectives and hypotheses of the clinical investigation

Content

A.5 Objectives and hypotheses of the clinical investigation [...] The objectives of the clinical investigation shall […]

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