Reference number
ISO 14155-2:2003
© ISO 2024
ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Edition 1
2003-05
Withdrawn
Withdrawn (Edition 1, 2003)

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.

General information

  • Status
     : Withdrawn
    Publication date
     : 2003-05
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 9
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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