Medical Device Testing Services
Medical Device Testing Services
 

Radial Force Testing

Implantable Medical Devices 

Radial Force Tester

Scope:

This benchtop test provides empirical evidence of the force exerted by a self-expanding stent, as a function of the stent diameter under the conditions of expansion and compression. The samples are deployed within the testing fixture iris until the initial diameter is less than or equal to the minimum vessel diameter indicated in the IFU. A test engineer will record the force while the stent is expanded to the maximum indicated vessel diameter. Then, the engineer will record the force while the stent is compressed to the minimum nominal indicated vessel diameter.  The test is conducted in body temperature air (37°C).

Standards:

ISO 25539-1: Cardiovascular implants, Endovascular devices, Part 1: Endovascular prostheses.  

ISO 25539-2: Cardiovascular implants, Endovascular devices, Part 2: Vascular stents.  

Equipment:

MDT has an MSI RX500 radial force tester including an optional environmental chamber tank (not pictured).  System features include:

Test Protocol & Setup:

Testing schedules and resource needs are determined during project kickoff meetings with MDT engineers and the customer. Services are performed in accordance with ANSI/ISO/IEC 17025-2005. In compliance with this standard, standard operating procedures and test protocols specific to the project are used.

Test Reports:

In compliance with ANSI/ISO/IEC 17025-2005, MDT test reports include comprehensive documentation and summary of the test protocol and results. All reports are GLP compliant and can be submitted directly to regulatory agencies. Any test method deviations, additions, or exclusions are documented and reviewed with the customer prior to beginning the test. Information within the report includes the specific test conditions, statements of compliance with test protocol, and the estimated measurement uncertainty. The reported results only relate to the items tested. Any opinions and interpretations provided by MDT are clearly marked as such. Any additional information required by customer-specific methods will also be noted. At the conclusion of the test, MDT provides the customer with a Microsoft Windows formatted CD containing copies of all raw data, inspection results, and other information collected during the test (see example test reports).

Please take a few moments to tell us more about your device and test requirements in our short questionnaire, and we will be happy to provide you with a quote.

 

Radial Force Testing

RX500 SS 12-segment

Radial Force Testing

Example stent setup with 12 contact points