Hemocompatibility

When a medical device comes into contact with blood, the risks are immediate and significant. Will it cause haemolysis? Activate the complement cascade in the innate immune system? For device manufacturers, the uncertainty around these interactions can lead to regulatory delays, costly redesigns, and ultimately, risks to patient safety. Knowing when to begin testing, understanding the right methods, and interpreting complex results can feel overwhelming—especially under time and budget pressure.

That’s where the Eurofins Medical Device Services network of laboratories comes in. With more than 30 years of experience in biological safety testing, we provide a full suite of hemocompatibility testing solutions that align precisely with ISO 10993-4 requirements. No matter if you're evaluating thrombosis potential, coagulation, platelet behaviour, haematological effects, or complement cascade activation, we help you understand the need for hemocompatibility testing and assess the risk of blood interaction with confidence. Our services support both standard and custom test designs for medical devices with direct or indirect blood contact.

We perform both static and dynamic test designs. Dynamic systems—such as Chandler® Loop and agitation models—simulate realistic clinical conditions, accounting for variables like shear stress and flow dynamics. These models use whole human blood, allowing us to evaluate all five ISO 10993-4 endpoints with greater accuracy via ELISA-based analysis and scanning electron microscopy.

Regulatory

• ISO 10993-4: 2002 / Amd 1:2006 provides general requirements for evaluating the interactions of medical devices with blood, including five test categories:
• Coagulation
• Complement System
• Hematology
• Platelets
• Thrombosis

This guideline describes biological evaluation in general terms and requires testing strategies that mirror the device’s intended clinical use.

• ISO 10993-1 Table A.1 – "Endpoints to be addressed in a biological risk assessment”

Dynamic Hemocompatibility

Medical devices that come into contact with circulating blood require thorough evaluation. For these products, testing individual endpoints using static systems is often insufficient. Instead, dynamic test systems should be used to accurately assess the influence of geometry and flow conditions on blood components.

Even materials that are physico-chemically similar can exhibit different hemocompatibility profiles in clinical settings. To reflect these real-world differences, in vitro models must support dynamic testing under varying shear stresses, using human whole blood with defined anticoagulation protocols.

Dynamic test models offer a critical advantage: they enable comprehensive evaluation of all five ISO 10993-4 endpoints through ELISA-based analysis of specific activation markers. They also allow visualisation of cell and protein adhesion to the test material using scanning electron microscopy, providing deeper insight into blood–material interactions.

All testing is conducted under GLP and non-GLP conditions, giving you flexibility depending on your regulatory and development stage needs.

*All in vivo assays are performed by our partner lab.

Performance testing

Beyond biological safety, the performance of blood‑contacting medical devices plays a critical role in ensuring clinical reliability. Eurofins Medical Device Services provides specialised performance testing to assess blood cell damage, thrombogenicity, hydrodynamics, flow behaviour, durability, structural integrity, and the functional behaviour of cardiovascular and blood‑handling technologies. Leveraging the expertise of ac.biomed — now part of the Eurofins network — our ISO/IEC 17025‑accredited laboratories support manufacturers of heart valves, stents, vascular prostheses, cannulas, oxygenators, blood pumps and other circulatory devices with validated methods, custom test development, and regulatory‑aligned documentation. These complementary performance evaluations help manufacturers understand device behaviour under physiological conditions, reduce development risk, and support robust submissions to the FDA, EU MDR and other global regulatory authorities.

Hemocompatibility Test Panel

• Agitation Model
• Chandler-Loop Design
• Complement Activation
• Dynamic Test Designs
• Haemolysis
• Platelet Count
• Static Test Designs
• Thrombogenity