BS EN ISO 14155-2:2003

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

BS EN ISO 14155-2 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimizing the scientific validity and

reproducibility of the results of a clinical investigation. This standard does not apply to in vitro diagnostic medical devices.

ISBN: 0 580 41910 X