This part of EN ISO 14155 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 optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
Legislation related to this standard
Active implantable medical devicesHarmonized/Supporting
EN ISO 14155-2:2003
99.60 Withdrawal effective
Jul 15, 2009
EN ISO 14155-2:2009