Confidence in vascular prostheses testing
When developing vascular prostheses, devices must perform reliably under constant physiological stress and comply with strict regulatory expectations. Failures can result in serious clinical consequences, including rupture, thrombosis, or long-term complications. Pressure to optimise designs, demonstrate compliance, and reach the market quickly continues to intensify. So balancing safety, performance, and speed can be a complex and demanding challenge for manufacturers.
The Eurofins Medical Device Services (MDS) network of laboratories supports manufacturers with the expertise, infrastructure, and regulatory insight required to confidently navigate these challenges. Our global network brings together highly skilled scientists, advanced instrumentation, and harmonised processes to deliver precise, reliable testing solutions for vascular prostheses.
Our teams provide comprehensive evaluation of mechanical integrity, including burst pressure and kink resistance testing under physiologically relevant conditions. These assessments ensure that devices can withstand real-world stresses throughout their lifecycle. Our flow performance studies measure hydraulic resistance, permeability, and leakage, generating critical data to confirm consistent and stable blood flow.
Beyond performance testing, Eurofins MDS delivers detailed regulatory documentation aligned with ISO standards and FDA expectations. Our teams understand the nuances of global compliance requirements and structure reporting to support CE marking and international approvals efficiently.
Our approach is grounded in data-driven insight. By analysing test outcomes in detail, we help identify opportunities for design optimisation, whether in materials, coatings, or structural configuration. This enables manufacturers to refine their products with clarity and purpose.
Partnering with Eurofins MDS means working with a team that supports innovation, safeguards patient outcomes, and understands the scientific and regulatory demands of vascular prostheses.
Vascular prostheses testing solutions that empower
With vascular prostheses, excessive fluid transfer can result in leakage and associated complications, while insufficient permeability may hinder tissue integration and healing. These challenges place pressure on development teams to demonstrate precise control of graft properties and meet regulatory expectations.
The Eurofins Medical Device Services (MDS) network of laboratories provides integral water permeability testing in accordance with ISO 7198. We quantify fluid passage through graft walls using controlled pressure conditions designed to reflect clinical use.
Testing is conducted by our scientists across physiologically relevant ranges, enabling accurate assessment of in vivo performance. Our capabilities include long-term evaluation of permeability stability, helping to ensure consistent behaviour over the device’s intended lifespan. Detailed, ISO-aligned reporting supports CE marking and international regulatory submissions.
Through robust testing and expert analysis, Eurofins MDS delivers the insights needed to optimise materials, refine design, and confirm performance
Kink resistance testing
Vascular prostheses must perform reliably within complex anatomical pathways, where bending and flexion are unavoidable. If a graft kinks under these conditions, it can restrict blood flow, increasing the risk of thrombosis, ischemia, and device failure. Demonstrating consistent resistance to deformation is therefore essential.
The Eurofins Medical Device Services (MDS) network of laboratories provides kink resistance testing in accordance with ISO 7198. We determine the minimum bend radius at which the graft maintains lumen patency, making sure functionality is preserved even under challenging geometries.
Our testing programmes include dynamic flexion simulations to replicate physiological movement over time, alongside continuous assessment of lumen integrity to verify flow capacity during deformation. Detailed, ISO-aligned reporting supports CE marking and global regulatory submissions.
Through accurate measurement and expert evaluation, Eurofins MDS helps identify potential design limitations and enable targeted improvements in materials and structure, ensuring compliance and long-term device reliability.
Burst pressure testing
When vascular prostheses fail under pressure, the consequences are immediate and severe. Rupture risks, compromised patient safety, and regulatory delays all place significant strain on development timelines. Demonstrating that your device can withstand physiological and elevated pressures is essential, not only for compliance, but for clinical confidence and long-term performance.
The Eurofins Medical Device Services (MDS) network of laboratories delivers burst pressure testing to the standards laid out under ISO 7198. We determine ultimate pressure thresholds using controlled, standardised pressurisation profiles that reflect real-world conditions.
Our approach includes detailed failure mode analysis to identify structural weaknesses and material limitations. Comprehensive, ISO-aligned documentation supports CE marking and global submissions, helping to streamline regulatory pathways. Through precise measurement and expert interpretation, Eurofins MDS provides you with the data required to validate durability, refine design, and strengthen product performance.