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Norm

ÖNORM EN ISO 14155-2

Issue date: 2003 07 01

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

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 compila...
Withdrawn: 2010 01 01
Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German | English
Optionally co-design standards:
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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ÖNORM EN ISO 14155-2
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Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans ...
Norm
ÖNORM EN ISO 14155-2
2003 07 01
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans ...
Norm
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Norm
ÖNORM EN ISO 14155-1
Issue date : 2009 12 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
Norm
ISO 14155-2:2003
Issue date : 2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Norm
ÖNORM EN ISO 14155-2
Issue date : 2009 12 01
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)