Machine Solutions offers equipment and comprehensive testing services to meet ISO 10555 standards and FDA guidance document recommendations. Our innovative catheter and stent testing equipment was designed to provide accurate, repeatable, quantitative data giving our customers real results so they can develop world class devices.
Our experienced team can evaluate the performance characteristics of balloon catheters, guidewires, guide catheters, endoscopes, stents, and other interventional devices using Good Lab Practices and customer approved of study plans and protocols.
Leader in Hydraulic Burst and Leak Testing Equipment
Machine Solutions offers a sophisticated system for destructive and nondestructive hydraulic (distilled water) pressure testing angioplasty balloons as well as other medical devices. Crescent Design HBLT’s can be used for a wide range of applications including valves and luer fittings, pressure switches, liquid filters, plastic tubing, IV bags and more.
Test methods include:
- Burst to failure
- Balloon fatigue testing
- Compliance measurement
Non-destructive Leak Testing
Final inspection of products can be completed using pneumatic pressure testing. BW TEC offers several machines that can simultaneously test multiple devices by applying a specific pressure or vacuum to the product to confirm the product does not have any pin holes or leaks. BW TEC equipment features an easy-to-use HMI that collects all testing data to meet customer’s data analysis and storage needs.
Simulated Use Catheter Testing Equipment
With our 20+ years of experience, Machine Solutions has provided innovative testing equipment that is designed to measure trackability, torquability, and pushability of your interventional device for competitive testing or device validation.
MSI’s catheter testing equipment and the IDTE equipment can help validate your device to the following international recommendations:
- ISO (2003). ISO 25539-1 Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses.
- ISO (2000). ISO/TS 15539 Cardiovascular implants – Endovascular prostheses.
- FDA guidelines – guidance for industry and FDS staff non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems
Catheter Radial Force Testing Services
Radial expansion testing has been used for a variety of interventional devices, including balloon expandable stents, self-expanding stents, stent grafts, collagen plugs, embolic filters, vena cava filters and more. With our very own patented international testing technology,. Machine Solutions offers radial force testing equipment that provides optimal device evaluation, and inline manufacturing quality testing.
Catheter Stent Securement Testing
Machine Solutions offers a variety of stent securement testing equipment that is used to record the force required to dislodge a balloon-expandable stent from it’s proper position on a balloon. Each of our stent testing machines feature quick, simple software calibration, along with a high speed data acquisition system for repeatable results.
Device Testing Services
Machine Solutions offers comprehensive testing services for catheters according to FDA guidance document recommendations and ISO standards. ISO 10555 outlines general requirements for testing intravascular sterile use catheters.
Our experienced team can perform standard test methods to evaluate the performance of Catheters, Balloon catheters, or accessory devices (guidewires, guide catheters, endoscopes, stents, etc.).
The MSI Labs testing team provides Contract Testing or In-house / virtual testing workshops where we develop a protocol and study plan with you and run product on any equipment available.
Hydraulic Burst & Leak Testing
Crescent Design’s Hydraulic Burst-Leak Tester (HBLT) has become the world-wide standard for pressure testing catheters, balloons, fittings, valves, luers and many other disposable medical devices. The HBLT features a touch screen interface that allows the operator to program and save up to 40 different custom tests. Other features include built-in networking, test importing/exporting with other HBLT’s, selectable pressure display units and a total loss distilled water system that eliminates dissolved mineral precipitation inside the hydraulic system to improve reliability.
Get Wet or Keep Dry?
Some applications require hydraulic pressure, while others are better suited for pneumatic pressure. Learn more about the differences between Wet or Dry Burst & Leak Testing.
Test up to 10 Products At a Time With Smart Manifold
The more you can automate the more you can save, and that’s what our Smart Manifold helps you to do.
Connect the Smart Manifold to our Hydraulic Burst Leak Tester (HBLT) and you can do unattended testing of one to ten parts simultaneously. With three basic testing modes to choose from, the Smart Manifold lets you pressurize all selected ports simultaneously, or pressurize each selected port individually, or pressurize only one port at a time.
Balloon Compliance Measurement
Crescent Design HBLT can be upgraded to perform compliance testing include both contact and non-contact diameter measurement methods.
A variety of different water baths are available to accommodate compliance testing of products while submerged in temperature controlled water. The Compliance Test Fixture (CTF) uses a standard, low-force Mitutoyo Digimatic gauge for taking contact diameter measurements. Crescent Design’s Positioning Controller can be integrated with a Keyence LS7070 Optical Micrometer to take diameter measurement in multiple locations during testing.
Catheter Performance Testing
Machine Solutions’ IDTE equipment is used to accurately and repeatably measure forces of guidewires, catheters, guide catheters, and other interventional devices in simulated testing environment. For trackability testing, the load cell on the roller system measures the force to advance and retract the product though a simulated model. Standard tests include track, push efficiency, insertion force and more. The system can be equipped with a torque testing module to measure torque efficiency or rotational response in a straight path or simulated configuration.
Catheter Torque Testing
Catheter Torqueability or torque efficiency describes the measure of rotational feedback at the distal end of a device while imparting a rotation at the proximal end. Designed to meet the requirements of ISO 10555, ISO 25539, ASTM F2394, and the FDA catheter or guidewire guidance documents, MSI’s simulated use testing equipment uses torque sensors to measure torque efficiency or rotational response in a straight path or simulated configuration.
Standard test methods include:
- Torque strength
- Rotational response
- Torque to failure
- Rotational Bond strength
8 up Pneumatic Leak Tester
Pneumatic leak testing equipment provides non-destructive for tests in the production line. Up to 8 products can be simultaneously tested to a specific pressure or vacuum and held for a defined time.
Radial Force Testing
MSI’s radial force testing measures and records device characteristics including radial stiffness and strength, chronic outward force during expansion and radial reactive force during compression. By using highly precise sensors such as encoders, linear actuators and precision roller bearings, our catheter testing equipment has the capability to display force outputs in various units of hoop force, radial force or pressure. Each of our radial force testing machines offer many benefits such as:
- High speed data acquisition system
- Improved motion control
- Quick set-up
- Repeatable and reproducible data
- Increased diameter accuracy and resolution
Stent Securement Testing
Machine Solution’s stent securement testing equipment is proven to produce the most repeatable results compared to tape and shim methods. Our self-aligning system limits operator use so tests results will not be impacted, reducing the number of samples required to get statistically significant results. This equipment can be used for regulatory submissions, competitive product testing, R&D device evaluation and inline manufacturing quality assurance. Our stent testing machines give direct feedback on how adjustments to the crimping parameters may impact stent securement results, allowing R&D engineers to quickly optimize crimper processing settings.