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NS-EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

standard by Standards Norway NS-EN ISO , 10/01/2009

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ADOPTED_FROM:EN ISO 14155-2:2009 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.
 

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Published:
10/01/2009
Number of Pages:
28
 

Document History

  1. NS-EN ISO 14155:2011


    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    • Most Recent

  2. NS-EN ISO 14155-1:2009


    Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

    • Historical Version

  3. NS-EN ISO 14155-2:2009

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    Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

    • Historical Version

  4. NS-EN ISO 14155-1:2003


    Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)

    • Historical Version

  5. NS-EN ISO 14155-2:2003


    Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)

    • Historical Version

  6. NS-EN 540:1993


    Clinical investigation of medical devices for human subjects

    • Historical Version