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ISO 14155-2:2003
Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans
This standard has been revised by: ISO 14155:2011
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.
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Edition: 1 (Monolingual) ICS: 11.100.20 Status: Withdrawn Stage: 95.99 (2011-01-21) TC/SC: ISO/TC 194 Number of Pages: -
Revised by: ISO 14155:2011
Revises: ISO 14155:1996
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No corrigenda or amendments available
