YY/T 0808-2010Standard test methods for in vitro pulsatile durability testing of vascular stents (English PDF)

YY/T 0808-2010 is the English-translated version of 血管支架体外脉动耐久性标准测试方法.

YY/T 0808-2010 is the Chinese standard "Standard test methods for in vitro pulsatile durability testing of vascular stents".

Its scope clause reads: This test method by applying a pulsating fluid load makes the stent is similar to the in vivo environment of the diameter of blood vessels to evaluate the level of expansion The durability of the stent can.

This method has been applied to the test sample holder expansion in the simulated blood vessels (simulated blood vessel elasticity) in. Typical durable Testing of the equivalent of 10 years (according to 72 beats per minute basis) or at least 380 million times the cardiac cycle.

This method is suitable for balloon expandable stent or metal alloy or self-expanding stents. Although this test method can also be used to coat stents, Degradable polymer scaffolds or stents, but not specifically for these stents specific properties.

This method is not recommended for the treatment of arterial aneurysm or peripheral vascular damage or to provide vascular access catheter stent graft or other products. but Some of the information may be used in the evaluation of these products.

This method is applicable due to the typical cyclical expansion vessel diameter leads to stent failure, but does not involve dynamic bending, twisting, stretching, squeezing Pressure or wear as a result of stent failure mode.

This method does not involve a curved vessel model test conditions. This method does not involve overlapping stents test conditions. This standard does not attempt to all the security issues involved elaborate, even if necessary, should be combined with its use.

Establish appropriate safety Health practices, as well as a clear management authority before the application of this standard is the user's own responsibility.

Description --- This document is the guide today most laboratories test implementation. If there are other more effective testing techniques to encourage use.

Whatever the testing technology use, the tester has an obligation to demonstrate a particular test, test equipment and test the feasibility of the application program. this The standard also includes how to select and proper calibration of all test equipment, and recommendations of the standard deviation from the place might be feasible, but We need to fully demonstrate techniques to be used. Its clauses include terms and definitions.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

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