Crush Resistance – Parallel Plates

The goal of the test is to determine the load required to cause clinically relevant buckling or a deflection equivalent to a diameter reduction of at least 50%, and determine the load and the displacement required to permanently deform or fully collapse the stent. The purpose of the test is to also determine whether the stent recovers from its original geometry after testing.

Test Procedure

Samples are tested for crush between two parallel plates. A compression testing system and a specific software are used to measure both the loading force on the sample and the displacement while decreasing the distance between the two parallel plates on which the sample is placed. The distance between the parallel plates is adjusted to a known distance using a calibrated dimensional gauge and then the distance is increased to a value superior to sample diameter. A sample is placed on the support plate in the orientation anticipated to have the least amount of crush resistance. The sample is compressed using a uniform rate of compression until final distance value defined is reached. Load and displacement are continuously recorded during cycles.

A physiological temperature of 37°C can be used for thermo-sensitive material

Equipment

Tank with thermal regulation system

Calibrated thermometer

Automatic compression system with parallel plates system including:

– Calibrated dynamometer

– Stepping motor

– Software

Calibrated gauge block

Measured Parameters

Force

Displacement

Temperature

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

OLE0609

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