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

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard reference method using redrafted ASTMF2477. "Stent pulsatile durability Standard Test Method for" the preparation of 2007. This standard ASTMF2477.2007 technical differences are as follows:

--- Deleted the Chapter 9, "precision and bias" and Chapter 10, "keyword";

--- The reference to Appendix X1, Appendix X2 to the Appendix B, remains unchanged. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard by the national orthopedic implants and surgical instruments cardiovascular implants Standardization Technical Committee Technical Committee (SAC/TC110 / SC2) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, minimally invasive medical devices (Shanghai) Limited. The main drafters of this standard. Fan platinum Wang Guohui, Ma Chun Bao, Sun Huili, Zhang Lu, Li Yong. Stent pulsatile durability Standard Test Method

1 Scope

YY/T 0808 is the bench durability test for the vascular stent. A stent implanted in an artery is loaded by every heartbeat, roughly forty million times a year, and the failure it has to be shown not to suffer is fatigue fracture of its struts. The test method accelerates that history in vitro, cycling stents in a mock vessel under pulsatile pressure for the equivalent of ten years or more, and defines how the loading, the vessel compliance and the inspection for fracture are handled so that results mean the same thing between laboratories. It sits alongside YY/T 0663.1 on endovascular prostheses in the Chinese cardiovascular implant framework. For a manufacturer of coronary or peripheral stents seeking Chinese registration, this is the method behind the durability data.

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.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

YY 0500-2004 cardiovascular implant artificial blood vessels

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Cardiac cycle cardiaccycle Diastolic and systolic heart every time a cycle is formed.

3.2 Compliance compliance Since the cyclic pressure changes caused by changes in blood vessel diameter. Compliance as defined in

8.10.5 YY 0500-2004 expressed as The percentage change of each 100mmHg pressure caused by changes in the diameter of blood vessels, the following formula. Compliance (%) = Dp2-Dp