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Fatigue Durability Test ISO 25539 / ASTM F2477

Normative References  

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

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

ISO 7198: Cardiovascular implants -- Tubular vascular prostheses

ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents.

DIN EN 12006-3: Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Blutgefäßstents und Hohlvenenfilter

The test setup consists of an array of mock vessels being pulsated by electro-dynamic motors to simulate physiologic loading conditions on the implanted stents.

Loading and unloading of a stent is defined by the decrease and increase of silicone vessel diameter, respectively. This value is used for digital closed-loop control of the test system and allows for high precision control even when testing extremely small or large (peripheral) vascular implants. The actual outer diameter of the mock vessel is scanned by a contactless diameter scanning system. The corresponding change of the inner diameter is evaluated by analytical means.

According to ASTM F2477, the typical duration of this test is 10 years of equivalent use (at 72 beats per minute), or at least 380 million cycles. Most of the fatigue tests have been operating at frequencies between 40 and 70 Hz.

EndoLab® GmbH verifies the fatigue life of vascular prostheses such as coronary and peripheral stents and bifurcated devices under simulated physiological loading conditions.