Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans
(Not available in French)
This standard has been revised by: ISO 14155:2011
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.
Document published on: 2003-05 Edition: 1 (Monolingual) ICS: 11.100.20 Status: Withdrawn Stage: 95.99 (2011-01-21) TC/SC: ISO/TC 194 Number of Pages: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
No corrigenda or amendments available