Cannula testing methods that accelerate timelines

For patients undergoing cardiopulmonary bypass and other extracorporeal circulation therapies, the performance of blood-contacting cannulae is directly linked to patient safety and clinical outcomes. Blood cell damage – such as haemolysis, platelet activation, or leukocyte depletion – can pose significant clinical risks, compromise therapeutic effectiveness, and create barriers to regulatory approval.

The Eurofins Medical Device Services (MDS) network of laboratories provides blood cell damage testing in full compliance with ISO 18193, supporting robust and reliable device validation. We quantify haemolysis under controlled flow and pressure conditions, ensuring accurate measurement of red blood cell integrity. Testing is conducted within clinically relevant operating ranges to replicate real-world treatment environments.

Our comprehensive reporting aligns with global regulatory expectations, helping streamline CE marking and international submissions. The data generated can also support design optimisation, from lumen geometry to biomaterial selection.

Combining advanced systems with scientific expertise, Eurofins MDS enables manufacturers to validate haemocompatibility, reduce risk, and get to market quicker. 

Effective extracorporeal circulation relies on maintaining appropriate separation between inflow and outflow blood streams within the cannulation strategy. When recirculation occurs, the efficiency of oxygenation, carbon dioxide removal, or circulatory support can be reduced. This can potentially compromise therapy effectiveness and patient outcomes. Minimising recirculation is therefore an important consideration in the design and validation of cannulae intended for extracorporeal applications.

The Eurofins Medical Device Services (MDS) network of laboratories delivers recirculation testing in line with ISO 18193 requirements. We assess recirculation rates using controlled flow and pressure conditions mirroring clinical use. This approach provides accurate insight into device behaviour across realistic operating ranges.

Our studies support design evaluation by highlighting flow disturbances linked to geometry, connectors, or use conditions. Our teams also produce structured documentation aligned with regulatory expectations, helping to streamline approval processes.

Through detailed analysis, advanced laboratory systems, and industry expertise, Eurofins MDS enables manufacturers to refine device performance, support compliance, and advance development programmes efficiently. 

During extracorporeal circulation procedures, cannulae are subjected to dynamic mechanical stresses such as patient movement, repositioning, and circuit manipulation. If a cannula kinks, collapses, or deforms under these conditions, blood flow may be restricted, potentially compromising circulatory support and patient safety. Demonstrating mechanical resilience and resistance to kinking, under clinically relevant stresses, is[GS1]  therefore a vital step in the development and validation of cannulae intended for extracorporeal use.

The Eurofins Medical Device Services (MDS) network of laboratories conducts kink resistance testing in accordance with ISO 18193. We assess how devices perform under defined bending angles and repeated flexing, generating clear data on their ability to maintain structural integrity. Flow integrity is also evaluated as part of our solution, measuring changes in blood flow and pressure during simulated kinking conditions.

Durability testing extends this analysis over repeated cycles to confirm long-term reliability. Each study is supported by detailed regulatory documentation, aligned with international requirements to support approval processes.

Through a combination of specialist expertise and controlled testing environments, Eurofins MDS helps manufacturers to identify weaknesses, refine designs, and demonstrate robust performance under clinical conditions. 

For extracorporeal circulation procedures, including cardiopulmonary bypass and extracorporeal life support, a secure and uninterrupted blood flow path through the cannula is essential to patient safety and treatment effectiveness. Any compromise in flow integrity – such as disruption, leakage, or blood stagnation - can increase the risk of blood damage, contamination, or reduced circulatory support efficiency.

Accordingly, demonstrating the durability and reliability of cannulae under representative flow, pressure, and usage conditions is a critical aspect of device validation. Robust performance throughout the intended duration of use supports safe clinical application and compliance with regulatory expectations for extracorporeal circulation devices.

The Eurofins Medical Device Services (MDS) network of laboratories conducts blood path integrity testing in accordance with ISO 18193. We evaluate leakage resistance under physiologically relevant pressures and flow rates, confirming that the system remains sealed throughout operation. Structural integrity assessments examine lumen geometry, material strength, and connector performance to ensure long-term durability.

The functional reliability testing we carry out is performed on ports, junctions, and access points to verify consistent, unobstructed blood flow. Detailed regulatory documentation is provided by our experts to support CE marking and international submissions.

Using advanced methodologies and specialist expertise, Eurofins MDS supports manufacturers in identifying design improvements, meeting compliance requirements, and progressing devices through development with clarity and control. 

During extracorporeal circulation procedures, excessive pressure drop across a cannula can increase the load on the circulatory system, impair effective blood flow, and introduce avoidable clinical risk. Uncontrolled hydraulic resistance may compromise the performance of cardiopulmonary support and related extracorporeal therapies. As a result, demonstrating predictable and controlled hydraulic performance under clinically relevant flow conditions has become a key requirement in the development and validation of cannulae intended for extracorporeal use.

The Eurofins Medical Device Services (MDS) network of laboratories offers pressure drop testing to ISO 18193 standards. Our scientists quantify hydraulic resistance across devices at a range of flow rates, delivering clear insight into performance under varying conditions. Testing is carried out using physiologically relevant parameters, including haematocrit, viscosity, and temperature, to reflect real treatment environments.

The team also assesses performance stability over extended operation to confirm consistent behaviour across repeated use. Detailed reports, generated in line with regulatory expectations, support CE marking and global submissions.

Drawing on advanced instrumentation and specialist expertise, Eurofins MDS enables you to evaluate design efficiency, address performance limitations, and support compliance at every step of the development process.