Abstract
1 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.
General information
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Status : WithdrawnPublication date : 2003-05
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Edition : 1Number of pages : 9
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- ICS :
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Biological evaluation of medical devices
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Previously
ISO 14155:1996
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Now withdrawn
ISO 14155-2:2003 -
Revised by
ISO 14155:2011
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