Want to see the Machine Solutions testing equipment in action? You can book an in person or virtual Lab Day where the MSI Labs testing team works with you to identify a procedure and perform device-catheter testing. These Lab Days provide raw data same day, which is some of the fastest turn around available.
Catheters or balloon catheters are devices used during minimally invasive interventional procedures to navigate the vasculature to target clinical sites for diagnosis or treatment procedures. Intravascular catheters have become essential to the practice of modern medicine by improving treatment methods, patient care, and quality of life. While catheter designs evolve and improve so to must the testing of these devices. Balloon catheters require rigorous functional and failure testing to ensure efficacy, safety, and performance.
Listed below are a variety of standard test methods our experienced team offers to evaluate the performance of Catheters, Balloon catheters, or accessory devices (guidewires, guide catheters, endoscopes, stents…). These test methods were designed following the outlined general requirements in the ISO 10555 and ISO 11070 standards, as well as the FDA 824 guidance document. All of MSI Labs contract testing follows Good Lab Practices and requires customer approval of study plans and protocols prior to performing testing.
There are a variety of methods used to evaluate the properties of catheters and balloons. ISO 10555 outlines general requirements for testing intravascular sterile use catheters. We offer comprehensive testing services for catheters according to FDA guidance document recommendations and ISO standards.
Utilizing MSI’s Radial expansion testing equipment, the RX650, following stepped parameters that control and record the Iris diameter and speed MSI Labs quantitatively collect the radial resistive forces and the Chronic outward forces that a stent experiences during a run process.
Standard test methods include:
Related Standards and Guides:
Utilizing MSI’s Stent Retention equipment, the SR1000, following stepped parameters that control and record retention diameter, distance, and speed MSI Labs quantitatively collect forces required dislodge a balloon expandable stent from the balloon catheter.
Standard test methods include:
Related Standards and Guides:
Utilizing our in-house Motorized push/ pull tester with data collection, MSI labs can control to move speed and distance while collecting force distance and speed data. This method of testing is for all ASTM and ISO linear tension and compression testing.
Related Standards and Guides:
Utilizing calibrated measurement equipment, MSI Labs will analysis and record product measurements at specified locations as a standalone dimensional verification or pre and/or post simulated use or other testing method.
Related Standards and Guides:
Utilizing MSI’s simulated use testing equipment, the IDTE, following stepped parameters that control and record proximal rotational direction and speed MSI Labs quantitatively collect proximal forces and rotations while also recording distal forces or rotations.
Standard test methods include:
Related Standards and Guides:
Utilizing MSI’s simulated use testing equipment, the IDTE, following stepped parameters that control and record insertion/withdraw- distance, speed, and delay MSI Labs quantitatively collect forces required to track a catheter or device through a tortuous path that mimics challenging in vivo physiologic/anatomic conditions.
Standard test methods include:
Related Standards and Guides:
Our knowledge of Standards, Documents, and Guidelines is ever growing. Should you have need to test to something outside of the list below our expert team will be happy to work with you to develop a Study Plan and Protocol to meet your needs.