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Full Description

This European Standard pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment before being placed on the market. This European Standard does not apply to in vitro diagnostic devices.
 

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


    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

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    Clinical investigation of medical devices for human subjects

    • Historical Version