ISO 10555 Catheter Testing services

Transform your regulatory compliance journey with our comprehensive testing solutions. Element inspects complete sterilized assemblies, including mounted stents and all accessory devices used in clinical procedures. Our testing evaluates every component of your catheter system under real physiological conditions.

•  Simulated Use Testing 
• Tip Pull, Flexibility and Kink Resistance, and Torque Strength 

• Dimensional Verification 

• Balloon-Rated Burst Pressure Testing 

• Balloon Fatigue Testing 

• Balloon Compliance Testing 

• Catheter Bond Strength 

• Catheter Body Burst Pressure 

Access a complete suite of validation testing that ensures your catheters meet all safety and performance requirements. From balloon-rated burst pressure testing with 99.9% survival rate at 95% confidence levels to comprehensive simulated use evaluation, we deliver the data you need for regulatory submission and market confidence. 

Simulated Use Testing: 

This test mimics the device’s clinical use by tracking the delivery catheter through a fixture that replicates in vivo conditions, like a tortuous path or aqueous environment. It uses sterilized assemblies, stents, and accessory devices in a 37°C water bath. Testing includes the observation of any abnormalities, device damage, or difficulties encountered during simulated procedures. 

Tip Pull, Flexibility & Kink Resistance, and Torque Strength: 

These tests measure the mechanical properties of the catheter, balloon, or guidewire within the simulated use model to assess how well they perform under real-world conditions. 

Dimensional Verification: 

This test ensures that accessory devices used in clinical procedures, such as introducers or guiding catheters, meet the required size specifications (e.g., smallest guiding catheter inner diameter) per ASTM F2081. 

Balloon-Rated Burst Pressure Testing: 

This test determines the rated burst pressure (RBP), or the pressure at which 99.9% of balloons can survive with 95% confidence, including testing in stents, per ISO 10555-4.  

Balloon Fatigue Testing: 

Balloon fatigue testing measures how balloons perform under repeated inflations, typically up to 10 inflations, to the rated burst pressure. We follow the “four corners” paradigm to test device sizes: largest diameter/longest length, largest diameter/shortest length, smallest diameter/longest length, and smallest diameter/shortest length. 

Balloon Compliance Testing: 

This test measures how the diameter of a deployed PTCA balloon changes with inflation pressure.  It includes single-point measurements of deployed PTCA balloon diameter and thickness of PTCA balloon material. It also includes measuring balloon inflation and deflation times to help manufacturers create compliance charts for selecting the right catheter size for the target vasculature. 

Catheter Bond Strength: 

We test the bonding areas of the catheter where adhesives or other methods are used to join components. The catheter is preconditioned by tracking it through a tortuous path fixture to assess bond strength. 

Catheter Body Burst Pressure: 

This test measures the maximum pressure a catheter body can withstand under injection conditions, including using syringes or automatic injectors. The test also includes measuring the contrast media flow rate at maximum burst pressure and typical clinical pressures. 

Our advanced testing facilities feature specialized equipment including digital stroboscopes for visual inspection, precision pressure monitoring systems, and temperature-controlled testing environments that maintain exact 37°C conditions. We utilize custom-designed fixtures that accurately simulate tortuous vascular pathways and specialized measurement tools that provide detailed data on catheter performance across all test parameters. 

Our expert team operates from strategically located medical device industry hubs, giving you convenient access to expert guidance. Find your nearest lab on our Locations Page.