DIN EN ISO 14155-1:2003-09

This International Standard defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to protect human subjects; ensure the scientific conduct of the clinical investigation; assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This International Standard pertains to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects; specifies requirements for the conduct of a clinical investigation such that it demonstrates that the medical device achieves the performance intended by the manufacturer, reveals any adverse events under normal conditions of use and permit assessment of the acceptable risks having regard to the intended performance of the medical device and specifies requirements for the organization, design including methodology, conduct, monitoring, data collection, documentation and evaluation of results of the clinical investigation of a medical device. This International Standard does not apply to in-vitro diagnostic medical devices.