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About This Item
Full Description
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to
- protect the rights, safety and well-being of human subjects,
- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- define the responsibilities of the sponsor and principal investigator, and
- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Document History
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ISO 14155:2020 Plus Redline
Clinical investigation of medical devices for human subjects - Good clinical practice- Historical Version
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ISO 14155:2020
viewing
Clinical investigation of medical devices for human subjects - Good clinical practice- Most Recent
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ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice- Historical Version
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ISO 14155-2:2003
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans- Historical Version
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ISO 14155-1:2003
Clinical investigation of medical devices for human subjects - Part 1: General requirements- Historical Version