7. Diagnostics: Point-of-Care devices
Patients are also increasingly required to use microfluidic devices for diagnostic purposes, with Point-of-Care (PoC) devices (figure 1 ).
A PoC test is an easy-to-use analytical test capable of providing the patient with a real-time medical diagnosis
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Bibliography
Standards and norms
- Microfluidic devices – Interoperability requirements concerning dimensions, connections and initial classification of devices - ISO 22916 - 2022
- Automated liquid handling systems – Part 1: Vocabulary and general requirements - ISO 23783-1 - 2022
- Microfluidics – Vocabulary - ISO 10991 - 2023
- Automated liquid handling systems – Uncertainty of measurement procedures - ISO/TR 6037 - 2024
Regulations
Commission Directive (EU) 2017/1572 of September 15, 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards principles and guidelines of good manufacturing practice for medicinal products for human use (CELEX: 32017L1572)
Directory
European EMPIR project "Establishing metrology standards in microfluidic devices" (MFMET, 20NRM02): https://mfmet.eu
GDR Micro and Nanofluidics : https://www.gdrmicrofluidique.com
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