After two years of hard work by 120 European experts, 10 focus group meetings, 90 working group (WG) meetings, and three revisions, the final version of the roadmap for Organ-on-Chip standardization is ready. You can download the roadmap here.

Organ-on-Chip (OoC) aims to develop high-tech solutions mimicking the function of an organ using microchip technology. Standardization is key for the further development of this field, and CEN and CENELEC are important facilitators through the Focus Group Organ-on-Chip (FG OoC).

The key recommendations in the newly published roadmap are:

Develop standards that provide harmonized terminology and definitions for important items and symbols in the OoC domain, especially including the relevant terms described in the roadmap;

Work on defining minimum reporting requirements for cells and biomaterials used in OoC systems,  in accordance with existing initiatives in this field;

Develop comprehensive standards that address the key technical aspects of OoC systems;

Evaluate how OoC is already covered in other laboratory practices and regulatory frameworks, and identify where a specific standardization approach is needed. Develop documentation that outlines the specific requirements for experimental design and data management in OoC studies where these gaps are identified. Develop a framework for the qualification of OoC models and their data for specific use cases;

Develop documentation that outlines the specific requirements for the use of OoC devices in various application domains, and facilitate and promote the use of OoC-based methods for specific applications.

Possibility of an ISO Standard

Now that the standardization needs in the field of Organ-on-Chip have been identified, the FG OoC has advised submitting the work program for adoption to the International Organization for Standardization (ISO).

By choosing standardization at the international level, stakeholders recognize the broad global interest in the field and the various initiatives already underway. This acknowledges the global value chain for OoC technologies, and ensures that standards are developed with input from stakeholders worldwide, thus promoting innovation, interoperability, and safety. By leveraging international expertise and perspectives, these standards can promote harmonization, facilitate regulatory compliance, and accelerate the translation of OoC research into impactful applications for healthcare, drug discovery, and more.

Simultaneously, the FG advises to establish the creation of a CEN and CENELEC Joint Technical Committee to coordinate European interests and to keep an eye on alignment with European regulations.

Background

The need for standardization in Organ-on-Chip (OoC) was recognized by the Joint Research Centre (JRC) of the European Commission, the European Committee for Standardization (CEN), and the European Committee for Electrotechnical Standardization (CENELEC), supported by the European Organ-on-Chip Society (EUROoCS).

This resulted in a Putting Science Into Standards (PSIS) workshop ‘Organ-on-Chip: Towards Standardization’ in April 2021.

In March 2022, the Focus Group Organ-on-Chip (FG OoC) was established, with Andries van der Meer as Chairman and NEN (the Dutch Standardization Institute) as Secretariat.

If you would like more information on the subject, or you are considering becoming a member of the expert group, you can contact NEN's Suzie Noten or Lysette Meuleman.