The ANSI/AAMI/ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects Package defines procedures and requirements for the conduct and performance of clinical investigations of medical devices under normal clinical use. This package aims to protect human subjects, ensure the scientific conduct of the clinical investigation and assist monitors, investigators, ethic committees and all bodies involved in the conformity assessment of medical devices. This package includes ANSI/AAMI/
ISO 14155-1:2003 and ANSI/AAMI/
ISO 14155-2:2003.