Need help?

EN ISO 14155:2020 Standard

wave
Save  

  Keywords:

#requirements #document #risk #changes #management

This standard can be totally or partially supervised by:
  •   EN ISO 14155:2020/A11:2024
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Wednesday 1st of April 2026

      Description:

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

      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

    Wednesday 28th of January 2026

      Related Standards

    EN IEC 60118-0:2024

    Medical devices Regulation ((EU) 2017/745)

    Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids

    EN ISO 10993-12:2021

    Medical devices Regulation ((EU) 2017/745)

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

    EN ISO 13408-6:2021

    Medical devices Regulation ((EU) 2017/745)

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

    EN ISO 11737-2:2020

    Medical devices Regulation ((EU) 2017/745)

    Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

    EN ISO 11737-1:2018/A1:2021

    Medical devices Regulation ((EU) 2017/745)

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

    EN ISO 11737-1:2018

    Medical devices Regulation ((EU) 2017/745)

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

      Stay up to date

      ACCESS

    Search for a standard
    GO

    Register

    Already a member?
    Login

      OTHER APPLICATIONS

    If you are interested in DO160 tests, you can give a try to our other free of charge software:
    CE-Marking assistant, Version: 1.3.0