ISO 14155-2:2003
$55.25
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Published By | Publication Date | Number of Pages |
ISO | 2003-05 | 16 |
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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.
Published Code | ISO |
---|---|
Published By | International Organization for Standardization |
Publication Date | 2003-05 |
Pages Count | 16 |
Language | English |
Edition | 1 |
File Size | 245.8 KB |
ICS Codes | 11.100.20 - Biological evaluation of medical devices |
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