YY/T 0808-2010 in English

Scope

This test method evaluates the durability performance of the vascular stent by applying a fluid pulsating load to bring the vascular stent to a diameter expansion level similar to the in vivo environment. This method is applicable to stent test samples that have been expanded in simulated blood vessels (simulated blood vessel elasticity). A typical endurance testing period is equivalent to 10 years (based on 72 heartbeats per minute) or at least 380 million cardiac cycles. This method is suitable for metal or alloy balloon-expandable stents or self-expanding stents. Although this test method can also be used for coated stents, polymer stents, or degradable stents, it does not specifically address the properties unique to these stents. This method is not recommended for use with covered stents or other catheter products to treat aneurysms or peripheral vascular injuries or to provide vascular access. But some of the information may be used in the evaluation of these products. This method is suitable for stent failure due to typical periodic vessel diameter expansion, but does not involve dynamic bending, torsion, stretching, extrusion or wear and other modes of stent failure. This method does not involve the testing conditions of the curved blood vessel model. This method does not involve bracket overlap test conditions. This standard does not attempt to address all safety issues involved, but should be used in conjunction with them even if necessary. It is the responsibility of the user of this standard to establish appropriate safety and health operating practices and clarify administrative rights before application.