Stent & 支架移植检测服务

Stent testing is an important step in the preclinical validation process to assess compliance with standards and regulatory requirements. Element’s cardiovascular device experts offer a comprehensive suite of stent testing services including pulsatile durability, axial fatigue, 弯曲和扭转, inspections, 定制测试方法.  

Endovascular devices such as stents and stent-grafts are implanted through minimally-invasive procedures to address a vessel blockage and restore blood flow. 从药物洗脱和生物可吸收支架到血管移植, our experts test to the latest standards for a variety of clinical indications and anatomical locations.

Our stent and graft testing expertise allows us to evaluate the devices with a range of testing and inspection methods to determine dimensional attributes, 位移和位移力, 拉伸和弯曲强度, 径向力测量, and more. 

支架检测服务 

Pulsatile durability testing - ASTM F2477, ISO 25539-1, ISO 25539-2, ISO 7198

During pulsatile fatigue, Element tests devices in mock vessels mounted to a 支架/贪污测试仪，并使它们受到周期性压力脉冲的影响. The pulses create a dynamic radial strain in the mock vessel to simulate strains the device will experience in vivo. 

In our 复杂血管内装置脉动耐久性试验 article, we guide you through a step by step overview of pulsatile durability testing.

轴向疲劳试验- ASTM F2942， ISO 25539-1和ISO 25539-2

Axial 疲劳测试 may be used in tension or compression to mimic physiological loading conditions. 轴向疲劳试验的两个关键是抗压性能和信噪比曲线生成.

Crush resistance testing: We use crush resistance quasi-static tests radially or along the length of a stent to measure the stent’s ability to resist permanent deformation or cyclic fatigue to mimic 10 years of implantation. This test configuration is particularly useful in fatigue to study the impact of overlapping vessel interactions.

S/N曲线生成：我们的专家在我们的文章中概述了S/N疲劳测试 医疗器械疲劳测试提示. Load monitoring can be added to ensure that the specimen sees the desired load throughout the test and to detect specimen failures. 

弯曲和扭转耐久性试验。ASTM F2942和ISO 25539-2

These tests are applicable when the device’s clinical use would result in bending or torsional loading such as peripheral stent applications, especially superficial femoral artery (SFA) indications that experience additional loading caused by natural gait motion, running, sitting, and standing. 

我们开发了一个 各种各样的弯曲夹具 以适应弯曲试验，如纯弯曲, cantilevered, 结合纯粹和悬臂, constant radius, 压缩和剪切弯曲.

扭转疲劳试验- ASTM F2942， ISO 25539-1和ISO 25539-2

Element’s fixtures and test instruments can apply cyclical torsion loading to simulate a wide variety of clinical uses and anatomical locations, mounted directly on a test fixture or inside mock vessels and then secured on a test fixture. 施加张力/压缩的多轴加载夹具和仪器, 也可同时进行弯曲和扭转. 

Our article on 医疗器械扭转试验 描述外围支架的扭转载荷.

支架移植检测服务

血管移植试验。ISO 7198

除轴向外, 扭转和脉动耐久性试验, there are several additional tests we offer for vascular grafts per ISO 7198 to characterize the following properties:

• Longitudinal 抗拉强度 呈管状
• 管状结构的周向抗拉强度
• 管状受压爆裂强度
• Diaphragm pressurized burst strength and probe burst strength of graft in flat form
• 透析针反复穿刺后的强度
• 缝线保持强度
• 动态径向柔度

检验方法

Inspections are a key component of stent durability testing and are routinely performed before, 在疲劳试验期间和之后. 有些检查需要将设备从测试仪上拆下, 比如显微镜, 其他方法需要暂停测试, 比如内窥镜检查, while methods such as high-speed video and stroboscopes are useful while a test is running.

我们在支架疲劳试验中采用的主要检查方法有：

• Visual 
• 数码显微镜
• Endoscopes 
• 高速视频
• Strobe light
• 镍离子释放和颗粒试验用介质取样

了解更多im体育APP支架和支架移植测试服务的信息, 或者要求报价, contact our 心血管器械检测 experts today.