Launch international Organ-on-Chip Standardization Roadmap at EUROoCS 2024 – First Step Towards ISO Standard?

On the first day of the conference of the European Organ-on-Chip Society (EUROoCS) from July 3-5 2024 in Milan, the international Organ-on-Chip Standardization Roadmap has officially been launched. Andries van der Meer (UTwente and hDMT, The Netherlands), chair of the Focus Group Organ-on-Chip (FG OoC) and also chair of EUROoCS presented the roadmap for the more than 600 participants worldwide in the Aula Magna of Politecnico di Milano.

After 2 years of hard work by 120 European experts, 10 focus group meetings, 90 working group (WG) meetings, and 3 revisions, the final version of the roadmap for Organ-on-Chip standardization is ready. The roadmap can be downloaded here

Organs-on-Chips (OoC) are microfluidic devices, containing small samples of healthy or diseased tissues from one or more organs cultured in controlled smart microenvironments. The cells behave much as they would in the organ in which they are normally found. They can thus simulate body functions. Standardization is important for the further development of this field and NEN is closely involved, in particular by running the secretariat of the Focus Group Organ-on-Chip (FG OoC) and the Dutch expert group Organ-on-Chip.

Andries van der Meer

Click image to download Roadmap

Recommendations

The key recommendations in the roadmap are:

  • Develop standard documents 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. Do this in accordance with existing initiatives in this field.
  • Develop comprehensive standard documents 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 contexts of use.
  • 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.

ISO Standard?

Now that the standardization needs in the field of Organ-on-Chip have been identified, the FG OoC advises submitting the work program for adoption to ISO. By choosing standardization at the international ISO level, stakeholders recognize the broad global interest in OoC standardization 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. This promotes innovation, interoperability, and safety in a rapidly changing field. 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, it advises establishing the creation of a CENCENELEC Technical Committee to coordinate European interests and to keep an eye on alignment with European regulations.

Organization

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, and the European Committee for Electrotechnical Standardization (CEN and 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 (Netherlands Standardization Institute) as secretariat.

Join the Organ-on-Chip Expert Group

The Dutch Expert Group Organ-on-Chip follows the work of the European Focus Group Organ-on-Chip and coordinates the Dutch input. The expert group also connects various Dutch stakeholders and provides a platform for exchange of (international) knowledge and experiences. If you are a stakeholder in this field and would like to be involved in the development of possible standards, please become a member of our expert group. There are no costs associated with this membership.

More Information?

If you would like more information on the subject, or if you are considering becoming a member of the expert group, please contact Suzie Noten (suzie.noten@nen.nl) or Lysette Meuleman (lysette.meuleman@nen.nl).

Source: NEN / CENELEC

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