Standard

ISO 14155-2:2003

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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.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Expires:
  • Edition: 1
  • Version: 1
  • Document type: IS
  • ICS 11.100.20
  • ISO TC ISO/TC 194

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