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About This Item

 

Full Description

1 Scope

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 History

  1. ISO 14155:2020 Plus Redline


    Clinical investigation of medical devices for human subjects - Good clinical practice

    • Historical Version
  2. ISO 14155:2020


    Clinical investigation of medical devices for human subjects - Good clinical practice

    • Most Recent
  3. ISO 14155:2011


    Clinical investigation of medical devices for human subjects - Good clinical practice

    • Historical Version
  4. ISO 14155-2:2003

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    Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

    • Historical Version
  5. ISO 14155-1:2003


    Clinical investigation of medical devices for human subjects - Part 1: General requirements

    • Historical Version