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Norm
ISO 14155-2:2003
Issue date: 2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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...
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Withdrawn
: 2011 01 21
Publisher:
International Organization for Standardization
Format:
Digital | 9 Pages
Language:
English
Currently valid:
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.
ISO 14155:2020
2020 07 28
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 14155:2011
2011 01 21
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 14155-2:2003
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Norm
↖
Norm
ISO 14155:2011
Issue date :
2011 01 21
Clinical investigation of medical devices for human subjects — Good clinical practice