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.
DIN EN ISO 14155-2-2009由德国标准化学会 DE-DIN 发布于 2009-11,并于 2009-11-01 实施。
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