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EN ISO 14155:2011 Standard

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  Keywords:

#requirements #document #risk #changes #management

This standard is superseded by:
  •   EN ISO 14155:2020
  • This standard can be totally or partially supervised by:
  •   EN ISO 14155:2011/AC:2011
  •   Directive

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

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

      Purpose

    ISO 14155 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. 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. ISO 14155 does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections or requirements of this document could be applicable. The main changes in the new edition are: — inclusion of clinical quality management, risk-based monitoring and statistical considerations,— reinforcement of risk management throughout the process of a clinical investigation,— clarification of the applicability of the requirements of this document to the different clinical development stages. The text of ISO 14155:2020 has been approved in Europe as EN ISO 14155:2020 without any changes and it supersedes EN ISO 14155:2011.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN ISO 14971:2012

    Active implantable medical devices Directive (90/385/EEC)

    Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

    EN ISO 11607-2:2020

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    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

    EN ISO 13408-1:2015

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

    EN ISO 13408-4:2011

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN ISO 13408-5:2011

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

    EN ISO 13408-6:2011

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

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