Table 8.

Hemocompatibility tests, summarized from [65].

Test Name	Recommended for	Purpose
Hemolysis assay	All devices except those that do not have direct contact with blood cells	Measures the damage to red blood cells when exposed to materials or their extracts and compares it to positive and negative controls.
Coagulation assays	All devices with blood	Measures the effect of the test article on human blood coagulation time.
Prothrombin Time Assay	All devices with blood	General screening test for the detection of coagulation abnormalities in the extrinsic pathway.
Partial Thromboplastin Time Assay	All devices with blood	Detects coagulation abnormalities in the intrinsic pathway.
Thrombogenicity test	Devices unsuited to in vivo	Required tests in coagulation, platelets, hematology, and complement system categories. The most common test for thrombogenicity is the in vivo method.
Complement activation	Implant devices	In vitro assay to measure complement activations in the human plasma due to exposure of the plasma to the test article or an extract. Measures complement activation.