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This document presents guidelines and a test protocol for leakage and burst pressure of microfluidic devices. The guidelines and the protocol in this document aim to operate within the following parametric range: non-hazardous water-based flow media, temperature (4-50) °C, pressure below 200 kPa (2000 mbar), and flow rates between 1 and 100 µL/min. The reasoning behind these operational parameters is to frame a subset without risks to safety or the environment. The testing of this document applies to device types that are not capillary flow devices. Furthermore, the testing was demonstrated with a microfluidic device made of COC (cyclic olefin copolymer) and mini Luer connectors. This test protocol originated from the discussions found in activity A1.2.2 (Heeren et al., 2022) and the work by Silverio et al. (Silverio, Guha, et al., 2022). Furthermore, this test protocol was created from the work of activity A1.2.3, which performed documented examples of leakage testing and burst pressure testing in the liquid flow laboratory at CETIAT (Villeurbanne, France). Activities A1.1.1 and A1.1.2, also contributed to this test protocol with vocabulary for microfluidic components and definitions of flow control terminology (Kartmann et al., 2022; Silverio, Metaxiotou, et al., 2022). |
