Arterial filter testing backed by expert science
When you’re producing an arterial filter for cardiopulmonary bypass or extracorporeal circulation, there is simply no margin for uncertainty. You need proof that microemboli, air, and particulates are consistently removed without compromising blood integrity or flow. At the same time, programme timelines rarely accommodate retesting, with regulators expecting clear, defensible evidence that performance holds up under clinically relevant conditions.
The Eurofins Medical Device Services network of laboratories helps manufacturers generate the performance and safety data crucial to validate arterial filters with confidence. Our teams combine deep scientific expertise with compliance-led reporting, giving you results you can use to make design decisions, reduce risk, and progress regulatory submissions.
Our arterial filter testing capabilities cover:
- Blood Cell Damage: Blood–material interaction assessment to minimise haemolysis, platelet activation, and clot formation.
- Filtration Efficiency: Quantification of microemboli and particulate removal under standardised extracorporeal flow conditions.
- Filter Flow Rate: Constant-flow assessment, including pressure drop.
- Air Handling Performance: Bubble-trapping and defoaming evaluation to support safe reinfusion.
- Regulatory Documentation: Comprehensive reporting aligned with ISO and FDA guidance to support CE marking and global approvals.
With advanced instrumentation, expert analysis, and strict adherence to international expectations, we help you demonstrate safety, validate performance, and strengthen confidence with clinicians, stakeholders, and reviewers.
Arterial filter testing methods that protect patients
If blood cells are damaged during extracorporeal circulation, patients run risks of anaemia, clot formation, and immune complications. As a manufacturer, you risk reduced treatment efficiency and greater scrutiny during regulatory review.
The Eurofins MDS network of laboratories provides blood cell damage testing of arterial blood line filters that is in full compliance with ISO 15675. Using clinically relevant conditions, we:
- Quantify haemolysis under standardised extracorporeal flow and pressure
- Run clinical simulations across physiologically relevant operating ranges for cardiopulmonary bypass and ECMO
- Evaluate performance stability over extended circulation.
Our expert team will provide you with comprehensive regulatory documentation to support CE marking and global approvals and will generate data to support optimisation of filter media, housing geometry, and biomaterial selection.
Air handling capability testing you can trust
Even small volumes of residual air can introduce embolic risks and lead to severe complications for patients during extracorporeal procedures. Proving reliable air removal performance of arterial blood line filters is essential for both patient protection and regulatory compliance. Testing must show that devices can consistently eliminate air bubbles under realistic clinical conditions and maintain stable performance throughout operation.
The Eurofins MDS network of laboratories performs air handling capability testing in full compliance with ISO 15675, supporting arterial blood line filter validation with robust, clinically relevant data. Our capabilities include bubble removal efficiency testing and defoaming characterisation, ensuring safe reinfusion without residual bubbles.
Our team also conducts clinical simulation studies, to replicate cardiopulmonary bypass and ECMO operating environments, in tandem with long-term performance stability evaluations to assess air handling consistency during extended use.
Your Eurofins MDS team will supply you with comprehensive regulatory documentation aligned with ISO 15675 to support CE marking and global submissions, helping you to demonstrate safety, optimise filter design, and accelerate market access.
Comprehensive filter flow rate testing solutions
When extracorporeal procedures are being performed, maintaining safe, efficient blood circulation is critical. Before blood is returned to the patient, arterial blood line filters play a vital role in removing microemboli, air bubbles, and particulate matter. As a manufacturer you must be able to demonstrate that your filters deliver stable, reliable flow rates under real clinical conditions and meet stringent regulatory expectations.
The Eurofins MDS network of laboratories provides comprehensive filter flow rate testing in accordance with ISO 15675. Our experts evaluate flow capacity under standardised extracorporeal circulation conditions and assess hydraulic resistance to measure pressure drop across the filter, confirming efficient blood passage and optimal device performance.
Our testing is carried out under physiologically relevant ranges to simulate cardiopulmonary bypass and ECMO environments enabling realistic performance evaluation, along with long-term studies to gauge flow rate stability during extended operation.
Eurofins MDS provides detailed regulatory documentation aligned with ISO 15675, helping you to demonstrate compliance, optimise filter design, and accelerate global regulatory approvals.
Our expert team will provide you with comprehensive regulatory documentation to support CE marking and global approvals and will generate data to support optimisation of filter media, housing geometry, and biomaterial selection.