Ensuring the safety and biocompatibility of blood-contacting medical devices requires precise evaluation of hemolysis — the damage of red blood cells under mechanical stress. Hemolysis testing is not just a regulatory requirement; it is a critical step in validating device performance and patient safety.

At our testing facility, we conduct hemolysis assessments in full compliance with ASTM F1841, ISO 18242, and ISO 14708-5:

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Blood pumps are life-sustaining technologies, but their interaction with blood flow introduces a critical challenge: thrombosis. The formation of clots within or around the device can impair pump performance, increase hemolysis, and pose serious risks to patient safety. That’s why thrombogenicity testing is a cornerstone of blood pump validation.

At our laboratory, we provide specialized thrombogenicity evaluations designed to meet the unique demands of blood pump development:

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The efficiency and reliability of blood pumps depend on their hydraulic performance — the ability to deliver precise flow and pressure under varying physiological conditions. Inadequate hydraulic design can lead to unstable circulation, increased hemolysis, or thrombosis, making performance validation a critical step in device development.

At our laboratory, we conduct hydraulic performance testing in full compliance with ISO 18242, the international standard for extracorporeal blood pumps. This ensures that every device is precisely evaluated against globally recognized benchmarks.

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At our laboratory, we conduct cavitation assessments in strict accordance with ISO 18242, the international standard for evaluating extracorporeal blood-contacting devices. This framework ensures:

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