Manufacturers of medical devices want their devices to be safe and biocompatible. It has been recognized that blood compatibility of materials is of pivotal importance for the compliance of blood-contacting devices. Blood in itself can be considered a very complex and intriguing organ with extensive interaction with all parts of the human body. The components of blood and some of the regulatory pathways will be presented. The implications for the scope of testing will also be discussed. Five testing categories have been outlined in the recently harmonized and published standard EN ISO 10993 – Part 4: 'Selection of tests for interactions with blood'. Aspects include materials characterization of medical devices and materials and biomaterials; in-vitro tests for blood compatibility; sample analyses from in-vivo studies; and batch release testing for finished products. Moreover, test conditions must consider the clinical use of the device, which implies testing in circulating blood. Finally, testing methods for studying blood-material interactions will be presented (ELISA, RIA; EIA, colorimetric methods; enzymatic assays; clotting assays; platelet functionality; antibody-binding studies; and fluorometric and luminometric methods).
Study load
0.25 ECTS credit point
Calendar
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Registration
T.G. (Theo) van Kooten, PhD (t.g.van.kooten@med.umcg.nl)
Department of Biomedical Engineering, W.J. Kolff Institute
Phone: +31 50 363 3122 / 3140
Coordinator
T.G. (Theo) van Kooten, PhD, PhD
Department of Biomedical Engineering, W.J. Kolff Institute
Additional information
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