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BSI BS EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects -- Clinical investigation plans
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BSI BS EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects -- Clinical investigation plans

PUBLISH DATE 2010
PAGES 20
BSI BS EN ISO 14155-2:2009

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.

SDO BSI: British Standards Institution
Document Number ISO 14155-2
Publication Date Jan. 31, 2010
Language en - English
Page Count 20
Revision Level
Supercedes
Committee CH/194
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