ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Reference number
ISO 14155-2:2003
Edición 1
2003-05
Retirada
ISO 14155-2:2003
32217
Retirada (Edición 1, 2003)

Resumen

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.

Informaciones generales

  •  : Retirada
     : 2003-05
    : Retirada de la Norma Internacional [95.99]
  •  : 1
     : 9
  • ISO/TC 194
    11.100.20 
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