Cardiotomy reservoir testing expertise
When blood handling systems fail to perform as expected during cardiopulmonary procedures, the risks are immediate and significant. From haemolysis and embolism concerns to inconsistent flow dynamics, the most minor inefficiencies can threaten patient safety and surgical outcomes.
The Eurofins Medical Device Services (MDS) network of laboratories supports you in addressing these challenges with precision and confidence. We combine scientific expertise with advanced testing infrastructure to deliver comprehensive validation of cardiotomy reservoirs, aligned with global regulatory expectations.
Step one of our approach is a detailed evaluation of blood-material interactions. By assessing haemolysis, platelet activation, and clot formation, we help you to understand how your device performs under realistic physiological conditions. These insights enable you to mitigate risk early and refine your design with confidence.
We then verify capacity and flow performance using controlled simulations that replicate clinical environments. This ensures your reservoir delivers stable flow, accurate volume handling, and reliable pressure characteristics throughout use.
Defoaming efficiency is another critical focus. Our teams assess air removal and bubble management to confirm that reinfused blood is free from harmful air emboli, supporting safer surgical outcomes.
Beyond performance testing, we provide comprehensive regulatory documentation designed to meet ISO and FDA expectations. Our reports are structured to support CE marking and global submissions, helping you move efficiently through approval pathways while maintaining full compliance.
Working with the Eurofins MDS network of laboratories gives you access to experienced scientists, proven methodologies, and a global infrastructure designed to support your development from concept through to commercialisation. With clear, data-driven insights, you can optimise reservoir design, strengthen regulatory submissions, and build confidence with clinicians and stakeholders alike.
Cardiotomy reservoir testing methods that deliver
Maintaining blood integrity during extracorporeal circulation poses several challenges. Devices must perform efficiently without causing harm to red cells, platelets, or leukocytes. When blood cell damage occurs, the consequences can include reduced therapeutic effectiveness, increased complication risks, and compromised patient outcomes. These pressures make robust, standards-driven validation a critical part of device development.
The Eurofins MDS network of laboratories provides blood cell damage testing in full alignment with ISO 15674. We quantify haemolysis under controlled flow and pressure conditions, delivering clear insight into red blood cell stability. Our testing is conducted within clinically relevant ranges, replicating surgical and ECMO environments to ensure accurate performance evaluation.
The comprehensive reporting we carry out supports CE marking and global regulatory submissions, while detailed datasets enable informed design improvements across biomaterials, coatings, and flow dynamics.
Through expert analysis and advanced test systems, Eurofins MDS helps you demonstrate haemocompatibility, strengthen device reliability, and move forward with confidence.
Air handling capacity testing
In extracorporeal circulation, managing air is critical to patient safety. Even small volumes of residual air can result in embolism, introducing serious clinical risks and undermining device performance. Manufacturers must demonstrate that oxygenators and reservoirs can consistently remove and control air under real-world conditions, while also meeting stringent regulatory expectations.
The Eurofins MDS network of laboratories delivers Air Handling Capacity testing in full compliance with ISO 15674. We evaluate bubble removal efficiency under standardised flow conditions, providing clear, quantitative insight into device performance. Testing is conducted across physiologically relevant operating ranges to replicate surgical and ECMO environments.
Our studies also assess performance stability over extended durations, ensuring consistent air handling throughout use. Comprehensive regulatory documentation supports CE marking and global submissions.
Through advanced instrumentation and expert analysis, we generate robust data to support design optimisation, improve device reliability, and accelerate regulatory approval.
Defoaming characteristics testing
Air management failures in extracorporeal systems can have serious consequences, both for patients and device manufacturers alike. Inconsistent defoaming may lead to microemboli, reduced treatment efficiency, and increased clinical risk.
The Eurofins Medical Device Services (MDS) network of laboratories delivers defoaming characteristics testing in full compliance with ISO 15674. Our experts assess foam dissipation behaviour, measuring both speed and stability to confirm safe reinfusion performance. Testing is conducted under clinically relevant operating conditions, replicating surgical and ECMO environments to ensure meaningful, applicable results.
Our approach includes long-term performance evaluation to verify consistency over extended use, alongside detailed regulatory documentation aligned with ISO requirements. These insights support design optimisation, from reservoir geometry to biomaterial selection, and strengthen submission readiness.
By combining advanced test systems with expert analysis, Eurofins MDS helps you demonstrate performance, reduce risk, and access global markets faster.