EVS-EN ISO 14155:2011

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

  Description:

  This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. This International Standard specifies general requirements intended to - protect the rights, safety and well-being of human subjects, - ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, - define the responsibilities of the sponsor and principal investigator, and - assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. It does not apply to in vitro diagnostic medical devices.

  Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of directive 90/385/EEC and conformance with the directive’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
   
  To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/
  

  Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of directive 93/42/EEC and conformance with the directive’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
   
  To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/
  

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