Rated Burst Pressure & Leak Testing

Our testing capabilities cover your complete medical device portfolio, from full assemblies to critical subcomponents. We specialize in testing balloon-mounted catheters, endovascular grafts, vascular prostheses, and complex fluid management systems including connectors, vent fittings, and catheter tip seals. Our expertise ensures thorough validation across your entire product range. 

Comprehensive testing solutions deliver the data you need for product validation and regulatory compliance. Our capabilities include low-pressure testing up to 100 psi and high-pressure testing up to 1,000 psi, balloon fatigue assessment, compliance determination, and crucial flow measurements including inflation/deflation timing and contrast media flow rates. Our comprehensive testing includes: 

• Low-pressure testing (up to 100 psi) 

• High-pressure testing (up to 1,000 psi) 

• Balloon fatigue assessment 

• Compliance determination 

• Inflation/deflation timing 

• Contrast media flow rates 

• Water entry pressure testing 

Your testing requirements are unique, and our solutions reflect that. We offer custom testing programs with programmable sequences tailored to your specific device and clinical requirements. Choose between air or liquid testing mediums, backed by comprehensive data collection that supports your regulatory submissions and quality assurance needs. Our solutions include:

• Custom programmable test sequences 

• Air and liquid testing mediums 

• Comprehensive data collection 

• Regulatory documentation support 

Rated Burst Pressure Testing: 
We use complete catheters or subassemblies with the balloon mounted on the catheter. This measures the pressure at which 99% of balloons can survive with 95% confidence. Ruptures, leaks, and pressure loss are recorded, and failure modes are noted to characterize the balloons. 

We also test non-stented endovascular grafts and vascular prostheses for burst strength per ISO 7198. Burst strength is measured by directly filling the device with fluid or using a balloon distention apparatus. Common tests for vascular grafts include water entry pressure, leakage, and compliance. 

Leak Testing and Detection: 
Leak tests detect manufacturing defects in fluid management systems by using air or liquid flow through components like connectors, vent fittings, and catheter tip seals. Our advanced equipment assesses leakage with either air or liquid. 

We also offer custom testing, allowing for programmable steps tailored to each device and its clinical use. 

Pressure and Flow Rate Testing: 
In balloon catheter pressure tests, the device is inflated to rated burst pressure (RBP) and held for 30 seconds (or another specified time). The balloon is then deflated, and the process is repeated for 20 cycles. 

Balloon or endovascular graft compliance is determined by the pressure-diameter relationship. We use balloon compliance charts to ensure proper catheter size selection for the target vasculature. Balloon inflation and deflation times are key specifications, as they control how long a vessel remains occluded and blood flow is obstructed. 

Contrast media flow rate testing for catheters is performed at both maximum burst pressures and during clinical use pressures. 

Access advanced instrumentation designed for both low and high-pressure applications, delivering the precise measurements you need. Our specialized equipment includes balloon distention testing apparatus and sophisticated fluid management system evaluation tools, ensuring accuracy across all test parameters. Available equipment includes:

• Low-pressure testing instruments 

• High-pressure testing apparatus 

• Balloon distention testing equipment 

• Fluid management system analyzers 

Our team operates from Life Sciences hubs across the world, providing convenient access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.

Our integrated testing approach combines multiple evaluation methods in one location, streamlining your validation process. From pressure testing to flow rate analysis, you get comprehensive data collection and expert interpretation to support your product development and regulatory compliance needs.