Materials used for blood contacting devices must be assessed for hemocompatibility to establish their biosafety assessment. Hemocompatibility assessment is essential to establish the biosafety of these materials, focusing on their interaction with blood. This assessment encompasses a range of crucial factors, including thrombotic responses, platelet reactions, complement activation, coagulation cascade initiation, and hemolysis.

Hemolysis Testing: Hemolysis evaluates the potential destruction of red blood cells when exposed to materials directly or their extracts. This vital test yields a percentage result, comparing your material's performance to positive and negative controls. It's a fundamental measurement recommended for all biomedical devices and materials, providing essential insights into their blood compatibility.

Hemocompatibility Test

Coagulation Assays: Coagulation assays, a cornerstone of secondary hemostasis testing, gauge critical blood coagulation times, such as prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin clot time. These tests are imperative for devices with any form of blood contact, delivering insights into how materials interact with this vital aspect of blood function.

Platelet Rich Plasma Adhesion: Platelet-rich plasma (PRP) adhesion assesses platelet activity when exposed to materials or extracts. By mimicking the final stages of the coagulation cascade, this test evaluates the formation and adherence of fibrin clots to material surfaces in a short time. It is a recommended examination for implant devices or materials in contact with circulatory blood.

Complement Activation Test: The complement activation test determines how materials or devices affect complement activation in human plasma. This evaluation unveils their potential to induce a complement-induced inflammatory immune response, critical information for implant devices or materials interfacing with circulatory blood.

Thrombogenicity Assessment: Thrombogenicity assesses the propensity of materials or devices to generate thrombus when in contact with blood. While in vivo testing is the gold standard for this measurement, ISO 10993-4 mandates tests within the four categories mentioned above for devices where in vivo testing is unsuitable.

At our Hemocompatibility Test Service, we employ a comprehensive approach to assess materials' blood compatibility. Our rigorous tests provide you with crucial data to ensure the safety and efficacy of your blood-contacting devices and materials. Rest assured, our commitment to your products' safety is unwavering. Explore our Hemocompatibility Test Service today and embark on a journey towards safer and more reliable biomedical devices. Contact us if you have any questions.

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