Artificial heart valves must be evaluated not only through physical testing but also by advanced computational methods that provide deeper insights into blood flow behavior. Computational flow field assessment is a powerful tool for visualizing and quantifying velocity fields, shear stresses, and turbulence patterns around valve structures. These analyses are critical for understanding hemocompatibility, optimizing design, and ensuring compliance with international standards.

At our laboratory, we perform computational flow field assessments in full compliance with ISO 5840, the global benchmark for heart valve prostheses. This ensures every device is validated using both experimental and computational approaches.

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Artificial heart valves must not only enable efficient forward blood flow but also prevent excessive leakage in the reverse direction. Steady backward leakage testing is a critical evaluation that measures regurgitant flow under controlled, non-pulsatile conditions. This ensures valves maintain proper closure and minimize risks of inefficiency, clot formation, or patient complications.

At our laboratory, we perform steady backward leakage testing in full compliance with ISO 5840, the international standard for heart valve prostheses. This rigorous assessment validates valve sealing performance and provides essential data for regulatory approval and design optimization.

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Artificial heart valves operate under relentless mechanical and physiological stresses, opening and closing millions of times throughout a patient’s life. To ensure long-term reliability, manufacturers must evaluate how valves behave under dynamic loading conditions — identifying potential points of weakness before they reach the clinic. This is where dynamic failure mode testing becomes essential.

At our laboratory, we perform dynamic failure mode testing in full compliance with ISO 5840, the international standard governing heart valve prostheses. This rigorous evaluation simulates real-world operating conditions to uncover mechanical vulnerabilities and validate device durability.

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In cardiopulmonary bypass and extracorporeal life support, oxygenators must do more than provide efficient gas exchange — they must also regulate blood temperature safely and effectively. The heat exchanger component ensures precise thermal control, protecting patients from hypothermia or overheating during critical procedures. That’s why Heat Exchanger Performance testing is a key requirement in device validation.

At our laboratory, we conduct Heat Exchanger Performance testing in full compliance with ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators, ensuring every device is rigorously evaluated under clinically relevant conditions.

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In cardiopulmonary bypass and extracorporeal life support, oxygenators must deliver efficient gas exchange while maintaining stable blood flow. One critical performance parameter is pressure drop — the resistance the device imposes on circulating blood. Excessive pressure drop can strain the pump, destabilize perfusion, and increase risks of hemolysis or clot formation. That’s why ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators require rigorous pressure drop testing as part of device validation.

At our laboratory, we conduct Pressure Drop testing in full compliance with ISO 7199 and FDA Guidance, ensuring every oxygenator is evaluated under clinically relevant operating conditions.

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Oxygenators are the core of extracorporeal circulation systems, responsible for maintaining life-sustaining gas exchange during cardiopulmonary bypass and ECMO procedures. Their ability to efficiently transfer oxygen into the blood and remove carbon dioxide is critical to patient safety and surgical success. That’s why Gas Exchange Performance testing is a fundamental requirement in device validation.

At our laboratory, we conduct Gas Exchange Performance testing in full compliance with ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators, ensuring every device is rigorously evaluated under clinically relevant conditions.

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Oxygenators are vital components in cardiopulmonary bypass and extracorporeal life support systems, responsible for maintaining gas exchange while preserving blood integrity. One of the most critical safety concerns is blood cell damage — including hemolysis and platelet activation — which can compromise patient outcomes during prolonged support. Evaluation of blood compatibility is therefore essential to validate device performance and meet regulatory requirements.

At our laboratory, we conduct Blood Cell Damage testing in full compliance with ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators, ensuring every device is assessed under clinically relevant conditions.

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Artificial heart valves must deliver consistent, unobstructed blood flow to sustain life. One key evaluations in valve development is steady forward flow testing, which measures how effectively a valve maintains forward flow under controlled, non-pulsatile conditions. This testing provides essential data on valve efficiency, pressure gradients, and effective orifice area — all key indicators of clinical performance.

At our laboratory, we perform steady forward flow testing in full compliance with ISO 5840, the international standard for heart valve prostheses. By adhering to this rigorous framework, we ensure every valve is validated against globally recognized benchmarks for safety and reliability.

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Understanding the complex flow fields around artificial heart valves is essential to ensuring their safety and effectiveness. Turbulence, shear stresses, and recirculation zones can all impact hemocompatibility, durability, and long-term patient outcomes. That’s why Particle Image Velocimetry (PIV) testing has become a cornerstone of advanced valve evaluation.

At our laboratory, we perform PIV testing in full compliance with ISO 5840, the international standard governing heart valve prostheses. This cutting-edge optical technique provides detailed, quantitative insights into valve hydrodynamics under clinically relevant conditions.

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Artificial heart valves must deliver precise, reliable blood flow under the demanding conditions of the cardiovascular system. Their hydrodynamic performance — the ability to regulate forward flow while minimizing regurgitation and pressure gradients — is a critical determinant of both safety and long-term clinical success.

At our laboratory, we perform hydrodynamic performance testing in full compliance with ISO 5840, the international standard governing heart valve prostheses. This ensures every device is rigorously evaluated against globally recognized benchmarks.

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