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EMPIR project publishes several technical reports and contributes to the development of five standards in the field of microfluidics

In medicine, the use of small volume of fluids in the nano-to-millilitre scale is increasingly used for on-spot diagnostic tests, such as glucose monitoring, pregnancy and infertility testing, infectious disease and cholesterol testing, among others. However, most products on the market are not traceable to reference standards.

EMPIR project ‘Establishing metrology standards in microfluidic devices’ (MFMET, 20NRM02) aims to develop a metrological basis for microfluidics and improve calibration procedures. A main objective is to share these novel developments with the metrology community and ensure that new information is easily accessible. The project website, where new outcomes are regularly posted, has already been viewed over 20,600 times from 68 countries.

The project and project partners have contributed to and supported the development of the following standards:

• ISO 22916:2022 - Microfluidic devices — Interoperability requirements for dimensions, connections and initial device classification
• ISO/FDIS 10991 – Microfluidics — Vocabulary
• ISO/ CD TS 6417 - Microfluidic pumps — Symbols and performance communication
• ISO 23783-1:2022 - Automated liquid handling systems — Part 1: Vocabulary and general requirements
• ISO CD/TR 6037 - Automated liquid handling systems – Uncertainty of the measurement procedures. 

The project also published the following technical reports on the project website and Zenodo:

• Metrology Methodology
• Definitions Symbols and Vocabulary of Flow Control
• Literature review of existing metrology and normative standards related to the flow properties and microfluidic devices
• Literature and market research: definitions, characteristics, specifications, application and function of flow control components
• Results from Microfluidics Survey
• Generic specification list for comparison of flow control components
• Test protocols for at least three liquid properties (such as density, viscosity and refractive index) related to microfluidic devices, and ensuring traceability to national standards and conformity to existing normative standards.
• Development of test protocols for microfluidic devices

Additionally, three peer-reviewed papers have been published in open-access journals:

• J.F. Gil, C.S. Moura, V. Silverio, G. Gonçalves, H.A. Santos (2023) Cancer models on chip: paving the way to large scale trial applications. Advanced Materials 2300692, 26 pp. https://doi.org/10.1002/adma.202300692
• Silverio, V., Guha, S., Keiser, A., Natu, R., Reyes, D. R., van Heeren, H., Verplanck, N., & Herbertson, L. H. (2022). Overcoming technological barriers in microfluidics: Leakage testing. Frontiers in bioengineering and biotechnology, 10, 958582.
• Van Herren, H,. Silverio, V., Pecnik, C., & Batista, E. (2022). Metrology challenges for microfluidics. CMM International

These advancements will help establish a metrology basis for microfluidics. The project coordinator Elsa Batista (IPQ) comments on the early success of the project:

‘This project has the advantage to bring together academia, manufacturers and National Metrology Institutes in order to develop new documents and standards in the field of microfluidics. Because of the different knowledge that was brought by each partner and our chief stakeholder – the Microfluidic Association it was possible to elaborate several reports, protocols, white papers and guidelines that are already being used by the microfluidic community. Some of these documents were also used for the development of standards and the roadmap of the Focus Group of Organ on Chip from CEN and more work is expected in the near future. The feedback from our end users is very positive since there is a big gap in protocol harmonization regarding connectivity, sensor integration, modularity and measurement of different quantities in microfluidic devices.’

This EMPIR project is co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States.

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