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ISO 14155-2:2003

Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans

This standard has been revised by: ISO 14155:2011

 

Abstract

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.

 

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