Hemocompatibility Testing (Blood Compatibility) (ISO 10993-4)

Materials used in devices that come into contact with blood, such as intravenous catheters, hemodialysis sets, blood transfusion sets, and vascular prostheses, need to be evaluated for blood compatibility to ensure their safety. All materials are to some extent incompatible with blood, as they may disrupt blood cells (hemolysis) or activate coagulation pathways (thrombogenicity) and/or the complement system. It is a recommended test method for device materials. The Hemolytic Effect (Blood Compatibility) (ISO 10993-4) test is performed to measure the damage that may occur when red blood cells are exposed to material or extracts and to compare them with positive/negative controls. The effect on blood coagulation time is measured. The Hemolytic Effect (Blood Compatibility) Test is recommended for all devices with blood contact.

Prothrombin Time Assay (PT): It is a general screening test for the detection of coagulation abnormalities in the extrinsic pathway.
Partial Thromboplastin Time Assay (PTT): Performed to detect coagulation abnormalities in the intrinsic pathway.
The most common test for thrombogenicity is in vivo methods, and for medical devices not suitable for this test method, the four covered by the ISO 10993-4 standard testing is required in each of the categories: coagulation, platelets, hematology, and the complement system.

Complement activation testing is recommended for implant devices in contact with blood. This in vitro test completes activation in human plasma as a result of plasma exposure to the test substance or extract and aims to demonstrate that the test substance can induce a complement-induced inflammatory immune response in humans.

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