EndoLab - Implant Testing Services Implant Testing

Radial Force ISO 25539

Normative References  



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

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

The purpose of this test is to determine the force exerted by a self-expanding stent, as a function of the stent diameter under the conditions of expansion and compression.

The stents will be deployed within the testing fixture until the initial diameter is less than or equal to the minimum vessel diameter indicated in the IFU. The force will be recorded while the stent is expanded to the maximum indicated vessel diameter. Subsequently, the stent will be compressed to the minimum nominal indicated vessel diameter.

For these tests, EndoLab® is using a compression station for Radial Force Testing (“iris tester”).  


Implant Testing - Radial Force ISO 25539