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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Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 14155
2021 11 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:202...
Norm
ÖNORM EN ISO 14155
2021 01 01
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:202...
Norm
ÖNORM EN ISO 14155
2012 02 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:201...
Norm
ÖNORM EN ISO 14155
2011 05 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:201...
Norm
ÖNORM EN ISO 14155-2
2009 12 01
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
↖
Norm
Issue date :
2009 12 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
Norm
Issue date :
2009 12 01
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
Norm
Issue date :
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
