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Standard

ISO 14155-2:2003

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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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  • Standard fra ISO
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  • Utgave: 1
  • Versjon: 1
  • Varetype: IS
  • Products.Specs.pages
  • ICS 11.100.20
  • ISO TC ISO/TC 194

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