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Hemocompatibility Testing

An important measure of hemocompatibility is the hemolysis test, which measures the ability of a material or material extract to cause red blood cells to rupture. Hemolysis testing should be performed on all materials directly contacting the bloodstream, or any materials used to form a conduit for fluids entering the circulatory system.

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This test is intended for materials that directly contact the blood stream or compromised tissues and for materials through which fluid passes before entry into the body. This is performed through direct method, extract method or both.
The activation of complement resulting from the use of a medical device has been associated with many adverse clinical findings. An enzyme immunoassay is used to screen for complement components in human serum that have been incubated with the test article. Elevated levels of complement components SC5b-9 and C3a indicate activation of the complement system. This test may be performed with a sponsor supplied comparison product.
The PTT assay is a general screening test for the detection of coagulation abnormalities in the intrinsic coagulation pathway. The test determines the time it takes citrated human plasma to form a clot when it is exposed first to the test material, then to calcium chloride and finally to partial thromboplastin. This test may be performed with a sponsor supplied comparison product.
Platelet and leukocyte counts are evaluated before and after exposure to the test material in human blood. Counts are evaluated for changes that may indicate activation, adhesion, aggregation, or lysis. This test may be performed with a sponsor supplied comparison product.
This assesses the thrombogenicity of the test material when compared to a sponsor-supplied material, preferably an approved medical device, when exposed to blood in an In Vivo model.

MHLW Testing

MHLW Hemolysis Assay
The purpose of this study is to evaluate the hemolytic potential of test articles.