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EVS-EN ISO 14155 V2:2011

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

General information
Withdrawn from 02.10.2020
Base Documents
ISO 14155:2011; EN ISO 14155:2011; EN ISO 14155:2011/AC:2011
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.10.2020
Main
02.11.2011
Main
03.08.2011
Corrigendum
EVS-EN ISO 14155:2011/AC:2011
Main
EVS-EN ISO 14155:2011
This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. This International Standard 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. It does not apply to in vitro diagnostic medical devices.
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