STANDARD
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 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.
General information on ISO 14155-2:2003
Timeline
An overview of the development of ISO 14155-2:2003 from 1996 til today.
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ISO 14155:20202020 07 28 Standard ISO 14155:2020, Edition: 2020 07 28Clinical investigation of medical devices for human subjects — Good clinical practice
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ISO 14155:20112011 01 21 Standard ISO 14155:2011, Edition: 2011 01 21Clinical investigation of medical devices for human subjects — Good clinical practice
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ISO 14155-2:2003Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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ISO 14155:19961996 02 29 Standard ISO 14155:1996, Edition: 1996 02 29Clinical investigation of medical devices
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