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About This Item
Full Description
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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AAMI/ISO 14155:2020
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Clinical investigation of medical devices for human subjects - Good clinical practice- Most Recent
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AAMI/ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)- Historical Version
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AAMI/ISO 14155-2:2003/(R)2008
Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans- Historical Version
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AAMI/ISO 14155-1:2003/(R)2008
Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirements- Historical Version