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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