From total knee prostheses to individual components, we offer a full suite of total knee replacement (TKR) testing services. Our experts have experience testing femurs, patellas, tibial trays and tibial bearings, and can assist with custom setups and challenging projects.

元素的医疗设备测试实验室为全膝关节(TKRS)进行了各种机械测试服务,包括双手间和联菩萨膝盖的疲劳测试,磨损测试和冶金评估。我们可以协助膝关节植入物的协议开发和设计,可行性研究和监管提交,并为许多行业最使用的标准提供测试。

我们的膝关节植入测试服务

元件’s team of experts are uniquely situated to provide every stage of knee implant testing in-house, giving us greater oversight over the testing process and the ability to manage your project from start to finish. Our testing labs feature dedicated frames for knee implant testing, giving us greater capacity and competitive turnaround times.

我们提供的一些服务包括:

  • 疲劳试验
  • 磨损测试
  • 运动测试范围
  • 接触压力using TEKscan capabilities
  • Bearing Interlocking Strength
  • 约束
  • Particle Evaluation

For more information about our knee implant testing services, or to speak with an expert,联系我们today.

膝关节植入测试

Standards We Test To

美国测试和材料学会乐动娱乐官网

ASTM F1223, ASTM F1672, ASTM F1800, ASTM F1814, ASTM F1800, ASTM F2083, ASTM F2723, ASTM F2777

International Standards Organization

ISO 14879, ISO 14242, ISO 14243

膝关节植入疲劳测试640 x 480 May 2018
膝关节植入测试

膝关节植入疲劳测试

是否可行性或提交目的,Element's fatigue testing services provide the critical data you need to validate your device design.

Tibial Tray (ASTM F1800 & ISO 14879)

Tibial tray fatigue testing (link to fatigue) is performed by fixating one half of the tibial baseplate and applying a constant amplitude load to the unsupported half of the baseplate. Per ASTM F1800 & ISO 14879, testing is performed to a run-out of 10 million cycles. For submission testing, five samples must survive 10 million cycles under at least 900 N of load.

胫骨轴承部件

对于后稳定的植入物,建议使用UHMWPE胫骨柱的剪切疲劳试验。六个样品以不同的载荷循环以开发S / N曲线。至少一个样本应完成满足1000万个周期的完整耗尽。

股植入物

在各种条件下评估疲劳性能的血糖。可以测试各种屈曲角度和固井配置以评估疲劳性能。可以测试S / N曲线和最小耗尽。

高屈曲下的胫骨插入耐久性

For knee systems designed to allow high flexion, this test method evaluates the ability of UHMWPE inserts to resist deformation and fracture due to repeated deep knee bend activities. Tests are performed in-vitro to 220,000 cycles at a 2,275 N load. Results are benchmarked by performing pre- and post-test scans, along with constraint tests.

接触压力and Constraint Testing 640 x 480 May 2018
膝关节植入测试

接触压力和约束测试

接触压力和分布可能对膝关节磨损性能产生显着影响,而约束测试对于确定植入系统的位错和运动阻力至关重要。

接触压力

利用各种压敏薄膜,元件提供了胫酮和股骨髌骨膝关节接触机械的接触应力分析。在具有不同正常负载的多个屈曲角度进行测试。

约束测试(ASTM F1223)

元件provides both translational and rotational knee constraint testing services per ASTM F1223. Anterior, posterior, medial, lateral and rotational tibiofemoral shear forces are applied to induce either subluxation or a specified angle of rotation. This test can be crucial when comparing standard inserts, congruent inserts, or posterior stabilized inserts.

膝关节植入磨损测试640 x 480 2018年5月
膝关节植入测试

膝关节植入磨损测试

膝盖磨损测试允许测量股骨部件和胫骨插入件之间的磨损率。元素可以在力或位移控制中执行磨损测试。

ISO 14243-1 or ISO 14243-3

轴向力(FZ),前/后部(FX),屈曲/延伸(MY)和胫骨旋转(MZ)耦合,以精确地模拟人膝部的复杂,同时运动。测试程序以1 Hz的频率运行至5,000,000个周期。以各种间隔,除去样品并精确测量质量损失。测试后,使用SEM / EDS设备对测试解决方案进行粒子分析,以创建综合的形态报告。

元素的膝盖佩戴测试框架包含:

  • 6 test stations and 2 load/soak controls
  • Ability to perform force or displacement-controlled testing (ISO 14243-1 or ISO 14243-2)
  • 牛溶液的环境室

Ready to request a quote?

Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.

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