Clinical investigation of medical devices for human subjects - Part 1: General requirements
This part of ISO 14155 defines procedures for conducting and performing 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
a) specifies requirements for conducting a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device
b) specifies requirements for the organization, conducting, monitoring, data collection and documentation of the clinical investigation of a medical device
c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.
ISBN: 0 580 41393 4
