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About This Item

 

Full Description

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

Cross References:
ISO 13485:2016
ISO 10993 (all parts)
ISO 15223-1


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 14155:2020

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

    • Most Recent
  2. BS EN ISO 14155:2011


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

    • Historical Version
  3. BS EN ISO 14155-1:2009


    Clinical investigation of medical devices for human subjects-General requirements

    • Historical Version
  4. BS EN ISO 14155-2:2009


    Clinical investigation of medical devices for human subjects-Clinical investigation plans

    • Historical Version
  5. BS 08/30116059 DC


    BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice

    • Historical Version
  6. BS EN ISO 14155-2:2003


    Clinical investigation of medical devices for human subjects-Clinical investigation plans

    • Historical Version
  7. BS EN ISO 14155-1:2003


    Clinical investigation of medical devices for human subjects-General requirements

    • Historical Version
  8. BS EN 540:1993


    Clinical investigation of medical devices for human subjects

    • Historical Version