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ISO 14155-2:2003

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

May 16, 2003
95.99 Withdrawal of Standard   Jan 21, 2011

General information

95.99     Jan 21, 2011

ISO

ISO/TC 194

International Standard

11.100.20  

English  

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14155:1996

NOW

WITHDRAWN
ISO 14155-2:2003
95.99 Withdrawal of Standard
Jan 21, 2011

REVISED BY

ABANDON
ISO/WD 14155-2

WITHDRAWN
ISO 14155:2011