Mechanical Blood Trauma in Circulatory-Assist Devices
6. In vitro testing devices for blood biocompatibility
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The current ASTM recommendation for the Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps was developed and approved in 1997 (ASTM F1841-97) and then reapproved in 2005. The scope of this standard covers the assessment of the hemolytic properties of continuous flow blood pumps used in extracorporeal or implantable circulatory assist devices and is based on an assessment of the device’s effects on hemolysis over a certain period of time. For this assessment, a recirculation test is typically performed for 6 hrs. The recirculation loop in Figure 6-1 demonstrates a recently designed test flow system. The major...