AAMI/ISO 14155:2010

Addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. 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 clinical investigation results; and assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.