ISO/DIS 14155 2:2003 PDF
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Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation plans
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.
| Edition | 2003 |
|---|---|
| Standard Part No | 2 |
| Published Date | 2003 |
| Published By | ISO/DIS |
| Page Count | 9 |
