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ISO 14155-2:2003

May 2003 Withdrawn

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Abstract

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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Standard from ISO
Published: May 16 2003
Withdrawn: January 21 2011
Period for objection until: November 1 2001
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.20
International TC: ISO/TC 194

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Revised by: ISO 14155:2011
Adopted by: SN EN ISO 14155-2:2010
Adopted by: NF EN ISO 14155-2:2009
Adopted by: NF EN ISO 14155-2:2003
Adopted by: SN EN ISO 14155-2:2003
Revises: ISO 14155:1996

ISO 14155-2:2003

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ISO 14155-2:2003

ISO 14155:1996

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ISO 14155-2:2003

ISO 14155:1996

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