EMPIR project on medical microfluidic devices provides traceable standards and specifications

Developing new standards to accelerate the use of microfluidic devices in medical and pharmaceutical applications

Microfluidics, concerned with fluid-handling in the nano-to-millilitre scale, is used in medical applications for on-the-spot diagnosis, including pregnancy, glucose, and pH tests.

Completed EMPIR project Establishing metrology standards in microfluidic devices (20NRM02, MFMET) focussed on the metrology necessary to support standardisation for microfluids.

Project results include providing input to three documentary standards, and the design and characterisation of microfluidic chip transfer standards. Wide interest in the work of the project is demonstrated by the large number of stakeholders visiting the project webpage and downloading the documents available.

Three documentary standards

The work of this project has provided input to three documentary standards:

ISO 22916:2022 – Interoperability requirements for dimensions, connections and initial device classification: Lays out requirements to ensure that microfluidic devices are designed to be easy to use and more cost effective to manufacture, with ‘plug-and-play’ functionality.
ISO 10991:2023 Microfluidics – Vocabulary (ISO/TC 48/WG 3): Provides comprehensive definitions to improve communication and understanding across areas using microfluidics.
ISO/TS 6417 Microfluidic pumps – Symbols and performance communication: Published following the conclusion of the project, and provides symbols and datasheets for commonly used microfluidic pumps.

Full details of the contribution made to these standards can be found in the case study New standards for easy to use, cost-effective microfluidic devices.

Microfluidic transfer standards

Two different microfluidic transfer standard chips made of glass and polymer respectively were manufactured to test specific quantities like volume, flow and leakage. These were circulated between eight international laboratories in order to characterise the dimensions of the standards and the influence of various configurations of leakage channels on the established flow. This work has resulted in transfer standards fully characterised for flow, flow resistivity, and leakage values – and the chips are now available for laboratories to check their own capability for measuring these quantities. These chips have been used by organisations including FDA and NIST.

In addition, the chip transfer standards are being used in the current Metrology Partnership project MFMET II, where they are being characterised for additional quantities such as flow resistivity, shear stress and volume.

Project website

The project website has been popular, with numbers increasing daily.

Numbers at the time of publishing this story are:

Website views 118,541 from 68 countries
Average views per month: 1880
Downloads: 60,066

Project coordinator Elsa Batista from IPQ said

‘A website is often the primary gateway through which audiences discover a project. This year we have surpassed 100,000 views which demonstrates that the MFMET project website has become an important source of information for researchers, laboratories, policymakers, industry representatives, and other stakeholders interested in metrology and standardisation applied to microfluidic technology. These numbers show the growing interest in the project's activities, results, and contributions, as well as the effectiveness of the consortium's communication and dissemination efforts. Most importantly, the 60,000 documents downloads reflect the practical use of the knowledge generated by the project and its contribution to capacity building, collaboration, and the dissemination of metrological best practices and it indicates that visitors are not only accessing the website but are actively interested in its publications, technical resources, guidelines, and project outputs, recognizing their value and relevance. Together, these two milestones highlight the project's growing international recognition and demonstrate the lasting impact of its communication, outreach, and scientific activities and this is of highly importance in future standardisation contributions.

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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