ISO 11070 Guidewire Testing

Element evaluates all types of intravascular introducers, dilators, and guidewires, including those with specialized coatings and complex tip designs. Our testing capabilities cover standard and custom device configurations, including spring and coil tips, delivering comprehensive validation data that maps to your specific device requirements and intended clinical use. 

We perform visual inspections at multiple magnifications and validate coating integrity, particulate generation, and corrosion resistance to support your complete device validation needs. Our comprehensive testing suite includes:  

• Simulated Use Testing 

• Tip Pull, Flexibility and Kink Resistance Testing 

• Torque Strength and Torqueability Testing 

• Dimensional Verification 

• Joint Tensile Testing 

• Balloon-Rated Burst Pressure Testing 

• Balloon Fatigue Testing 

• Balloon Compliance Testing 

• Catheter Bond Strength 

• Catheter Body Burst Pressure 

Your testing program utilizes customized anatomical models designed to your exact specifications, including precise lumen diameter, bend radii, bend reversals, number of bends, tracking length, and coefficient of friction of tracking materials. We evaluate devices both independently and with relevant ancillary devices, providing thorough performance data for regulatory submissions. Our methods incorporate worst-case testing conditions and comprehensive documentation of all performance parameters. 

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. 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. 

Torqueability Testing: 
We evaluate torqueability using a simulated use model where the distal end remains unconstrained while the proximal end is rotated. Our reporting includes the rotational input to the resulting distal rotation at 90-degree interval and the proximal-to-distal rotation ratio for each sample.  

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: 
This measures how balloons perform under repeated inflations, typically up to 20 times, 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 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 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.

Our testing evaluates your device with anatomically relevant models designed to your specifications, including lumen diameter, bend radii, bend reversals, number of bends, tracking length, and coefficient of friction of tracking materials. We provide detailed observations on device compatibility, preparation requirements, and maneuverability.