CEN and CENELEC Focus Group Organ-on-Chip (FGOoC)

Organs-on-Chips are microengineered devices that contain living human tissues, which mimic key functions of real human organs in a laboratory setting. Organ-on-Chip devices are being applied as models in drug development, biomedical research, toxicology and risk assessment. The field of Organ-on-Chip is highly interdisciplinary, encompassing biology, materials science, chemistry, fluid physics, microfabrication, genetics, biotechnology and pharmacology, among others. The field is growing rapidly, leading to groundbreaking technological innovation, commercial activity and discussions about regulatory needs.

The FGOoC shall ensure interaction between all relevant European stakeholders interested in potential standardization in the field of Organ-on-Chip, map ongoing activities, define priority needs and opportunities, and recommend further action to ensure that standards support the deployment of Organ-on-Chip in industry and help to ensure its regulatory acceptance.

By demonstrating technological and biological relevance, standards can increase implementation and use by the industry, such as the pharmaceutical and chemical industry. Standards are also great tools to provide a basis for regulatory acceptance, facilitating the use of new technologies and new methods. With Organs-on-Chips, there is also the unique possibility to practically show that standards can have a central role in developing and applying Regulations. In the end, this will contribute to protecting human health and the environment. A clear example of future use is the replacement of laboratory animals by Organ-on-Chip.

The FGOoC will interact closely with the European Society of Organ on Chip (EUROoCS) that will readily provide access to a large network of OoC experts and resources to support standardisation activities. The FGOoC will set the basis for an active dialogue and cooperation between the communities of researchers and standardizers. Its first goals are to develop a roadmap providing an overview of already available suitable standards and identifying possible gaps, and establish an active dialogue between stakeholders, innovative projects and research.

Researchers and organizations active in Organ-on-Chip can express their interest in contributing to this Focus Group by contacting their National Standardization Bodies (NSBs-CEN) or National Committees (NCs-CENELEC).

Want to know more? Please check our dedicated Organ On Chip web page.