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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