Medical bone plates, bone screws and fixation devices are used throughout the body for a variety of trauma conditions and disorders. We provide testing of these devices to ensure they function safely when they are needed most.

As an industry leader inmedical device testing, we have experience testing a variety of products for mechanical strength and durability, includingfatigue, bend, and torsion testing. Our labs also offer complementary services, including particulate testing,porous coating evaluationand in-house project management.

我们的创伤板,骨螺钉和固定装置测试

除了提供对定制项目的测试设计和支持外,我们还经常测试到ASTM F382和ASTM F384用于骨板,ASTM F543用于骨螺钉,ASTM F1541用于外固定装置。对于具有不同要求的项目,我们的专家可以帮助确定最合适的测试标准。我们还可以提供指导和支持对监管要求的测试,包括FDA 510K..

Some of the devices that we test include:

  • Bone plates and bone screws
  • Spinal fixation assemblies
  • Intramedullary rods and nails
  • External Fixation Devices
  • Pins
  • Staples
  • Bone anchors
  • 缝线
  • Cables and Wires

有关我们骨板,骨螺钉和固定装置测试的更多信息,或要求引用,联系我们today.

Trauma Device Testing
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Internal Fixation Devices

元素为内部固定装置提供了全面的测试解决方案,从骨板和螺钉到髓内杆和钉子。进行的常见测试包括静态弯曲,张力和扭矩以及各种疲劳试验。

Bone Plates (ASTM F382 & F384)

Bone plates are tested to determine both static and dynamic bending properties. Samples are loaded into a 4 point bend test fixture and either bent to failure or cycled to a run-out of 1,000,000 cycles. Angled plates are tested in the same manner, with ASTM F384 guiding these specific angled designs.

骨螺钉(ASTM F543)

Bone screws must withstand a battery of testing as prescribed in the various annexes of ASTM F543. This testing includes torsional properties, insertion/removal torque, axial pullout force, and self-tapping performance (if applicable).

External Fixation Device 640 x 480 May 2018
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External Fixation Devices

Due to the modularity of many external fixators, there are a variety of test methods available depending on the application of your specific assemblage. Element’s team can assist you in determining the most appropriate test methods for your device.

External Skeletal Fixation Devices (ASTM F1541)

This specification outlines how to perform static and dynamic testing on external fixation devices to determine the mechanical properties of the device. ASTM F1541 defines the test procedures for various assemblages, including:

  • Connectors
  • In-plane compression of ring elements
  • 关节
  • Anchoring pins
  • Subassemblies
  • Schanz螺丝

准备要求报价?

我们可交付的是确定性 - 高质量的数据,测试报告和证书,您可以在做出关于您的材料和合规性的决策时绝对依赖。乐动娱乐官网与今天的专家参与。

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