BS EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects - Clinical investigation plans

Standard No.

BS EN ISO 14155-2:2003

Release Date

2003

Published By

British Standards Institution (BSI)

Status

Withdraw 2010-01

Replace By

BS EN ISO 14155-2:2009

Latest

BS EN ISO 14155-2:2009

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.

BS EN ISO 14155-2:2003 history

• 0000 BS EN ISO 14155-2:2009
• 2003 BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans