EN ISO 14155的本部分规定了医疗器械临床调查的临床调查计划（CIP）的编制要求。根据本标准的要求编制CIP并遵守其将有助于优化临床研究结果的科学有效性和再现性。 本标准不适用于体外诊断医疗器械。

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.