Superseded
Standard
Historical
DIN EN ISO 14155-2:2003-09
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2003.
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Summary
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.
Notes
A transition period, as set out in DIN EN ISO 14155-2 (2009-11), exists until 2010-03-21.
Technical characteristics
| Publisher | Deutsche Institut für Normung e.V. (DIN) |
| Publication Date | 09/01/2003 |
| Cancellation Date | 11/01/2009 |
| Page Count | 15 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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