Local Compression
The purpose of this test is to determine the deformation of the device in response to a localized compressive force perpendicularly applied to the longitudinal axis of the device, and to determine whether the stent recovers its original geometry after testing.
Test Procedure
After measuring the stent outside diameter, the sample is positioned on a specific bench fixture. The sample stands horizontally on a V shaped support. A piston, controlled by a stepper motor, is advanced to the device until we obtain a preload that ensures point of contact at a pre-defined location on the specimen with stent. Then, the displacement is applied at a fixed rate while measuring the resultant force. The test stops when the displacement reaches defined target value. Then the piston is moved back to acquire elastic behavior data during sample unloading. At the end of the test, piston displacement and force are recorded.
A physiological temperature of 37°C can be used for thermo-sensitive material
Equipment
Optical gauging machine
Thermostatic bath
Calibrated thermometer
Automatic compression system
Measured Parameters
Time
Distance
Force
Scope
Balloon expandable stents
Self expanding stents
Service Levels
Applicable Standards
ISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Related Tests
OLE1219
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