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DIN EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
This standard addresses the technical aspects of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes by defining good clinical practices for their design, conduct, recording and reporting of clinical investigations. It 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 investigation results, - assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This standard 14155 is not applicable to in vitro diagnostic medical devices.
Deutsches Institut für Normung [din]