膝关节植入物检测| im体育APP | im体育APP-im体育平台app下载

From total knee prostheses to individual components, we offer a full suite of total knee replacement (TKR) testing services. 我们的专家有检测股骨的经验, 髌骨, 胫骨托盘和胫骨轴承, and can assist with custom setups and challenging projects.

im体育APP’s medical device testing labs perform a variety of 机械测试全膝关节置换术服务, 包括疲劳试验, wear testing and metallurgical evaluation for both bicondylar and unicondylar knees. We can assist in protocol development and design, feasibility studies and regulatory submissions for knee implants, and provide testing to many of the industry’s most used standards.

我们的膝关节植入测试服务

im体育APP’s team of experts are uniquely situated to provide every stage of 膝关节植入物测试 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 膝关节植入物测试, giving us greater capacity and competitive turnaround times.

我们提供的服务包括:

疲劳测试
磨损测试
运动范围测试
接触压力 using TEKscan capabilities
轴承联锁强度
约束
粒子的评估

For more information about our 膝关节植入物测试 services, or to speak with an expert, im体育APP 今天.

美国测试与材料学会

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

国际标准组织

Iso 14879, Iso 14242, Iso 14243

膝关节植入物测试

膝关节植入物疲劳测试

Whether for feasibility or submission purposes, im体育APP's fatigue testing services provide the critical data you need to validate your 设备设计.

胫骨托盘(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. 根据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.

胫骨支承部件

对于后稳定的植入物, shear fatigue testing of the UHMWPE tibial post is recommended. Six samples are cycled at varying loads to develop an S/N curve. At least one sample should complete full run-out to 10 million cycles.

股植入物

Femurs are evaluated for fatigue properties in a variety of conditions. Various flexion angles and cementing configurations can be tested to evaluate fatigue performance. Both S/N curves and minimum run-outs can be tested.

胫骨插入物在高屈曲下的耐力

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.

膝关节植入物测试

接触压力 & 约束测试

Contact pressure and distribution can have significant effects on knee implant wear properties, while constraint testing is critical in determining the dislocation and motion resistance of the implant system.

接触压力

Utilizing a variety of pressure sensitive films, im体育APP provides contact stress analysis of tibiofemoral and femoral-patellar knee implant contact mechanics. 测试 is performed at multiple flexion angles with varying normal loads.

约束试验(ASTM F1223)

im体育APP provides both translational and rotational knee constraint testing services per ASTM F1223. 前, 后, 内侧, 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, 相等的插入, 或者后路稳定植入物.

膝关节植入物测试

膝关节植入物磨损测试

Knee wear testing allows for the measurement of wear rates between the femoral component and the tibial insert. 元件可以进行磨损 testing in either force or displacement control.

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ISO 14243-1或ISO 14243-3

轴向力(Fz), 前/后力(Fx), 弯曲/扩展(我的), and tibial rotation (Mz) are coupled to accurately simulate the complex, 人的膝盖同时运动. Test programs run at a frequency of 1 Hz to 5,000,000 cycles. At various intervals, the samples are removed and precisely measured for mass loss. 在测试之后, a particle analysis is performed on the test solution using SEM/EDS equipment to create a comprehensive morphology report.

im体育APP的膝盖磨损测试框架包含:

6个测试站和2个负载/浸泡控制
Ability to perform force or displacement-controlled testing (ISO 14243-1 or ISO 14243-2)
牛溶液环境箱

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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. 今天就和专家交流.

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