Superseded
Standard
Historical
NBN EN ISO 14155-2:2009
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
Preview
Summary
1 Scope
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.
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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 10/02/2009 |
| Cancellation Date | 03/21/2010 |
| Page Count | 17 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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