压入/拔出测试



ASTM F 1820: Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device.



人工髋关节微动腐蚀测试


ASTM F 1875: Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface.



人工髋关节活动范围测试


ISO 21535: Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants.




人工髋关节疲劳测试


ASTM F 2580: Standard test method for evaluation of modular connection of proximally fixed femoral hip prosthesis.



撞击测试


ASTM F 2582: Standard test method for impingement of acetabular prostheses.




人工髋关节磨损​测试



ISO 14242-1: Implants for surgery - wear of total hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests.

ISO 14242-2: Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement.


ISO 14242-3: Implants for surgery - wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test.









小关节

名称描述内容
    
     髋膝关节类



人工髋关节疲劳测试


ISO 7206-4: Implants for surgery -- Partial and total hip joint prostheses -- Part 4: Determination of endurance properties of stemmed femoral components.


ISO 7206-6: Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components.


ISO 7206-8: Implants for surgery -- Partial and total hip joint prostheses -- Part 8: Endurance performance of stemmed femoral components with application of torsion.


ISO 14242-3: Implants for surgery — Wear of total hip-joint prostheses —Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test.


ISO 14242-2 (ASTM F1714-96): Implants for surgery — Wear of total hip-joint prostheses —Part 2: Methods of measurement.
















髋关节










在过去的50年里,人工髋膝关节置换取得了很多先进的成就,使得成千上万的患者受益,从而重新拥有正常的生活。随着科技的不断提高,对于人工髋关节产品的成功开发和改进而言,机械测试仍然是一个关键的组成部分。


Orthotek提供模块化和非组合式假体系统的机械试验。我们可以提供的髋关节植入物测试服务包括磨损测试,疲劳测试,静态测试和腐蚀测试。

股骨球测试

  

ISO 7206-9: Implants for surgery - Partial and total hip joint prostheses - Part 9: Determination of resistance to torque of head fixation of stemmed femoral components.  


ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads.

ASTM F 2345: Standard test methods for determination of static and cyclic fatigue strength of ceramic modular femoral heads.  



球头拔出测试

 

   

ASTM F 2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.



人工髋关节分类与规格


ISO 7206-1: Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions.

ISO 7206-2: Implants for surgery - Partial and total hip joint prostheses: Articulating surfaces made of metallic, ceramic and plastic materials.

ASTM F 1814: Standard Guide for Evaluating Modular Hip and Knee Joint Components.

ASTM F 2033: Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials.

ASTM F 2068: Standard Specification for Femoral Prostheses—Metallic Implants.

ASTM F 2091: Standard Specification for Acetabular Prostheses.


人工髋关节模拟测试



ISO 14242-1: Implants for surgery - wear of totaISO 14242-2 (ASTM F1714-96)
l hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests.


ISO 14242-2: Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement.


ISO 14242-3: Implants for surgery — Wear of total hip-joint prostheses —Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test.



ISO 14242-2 (ASTM F1714-96): Implants for surgery — Wear of total hip-joint prostheses —Part 2: Methods of measurement.



人工膝关节活动度测试


ASTM F 1223: Standard Test Method for Determination of Total Knee Replacement Constraint.



胫骨托疲劳测试


ASTM F 2724: Standard Test Method for Evaluating Mobile Bearing Knee Dislocation.





ISO 14879: Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance properties of knee tibial trays.

ISO 21536: Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants.

ASTM F 1800: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

ASTM F 2083: Standard Specification for Total Knee Prosthesis

膝关节










膝关节置换手术的数量随着人口老龄化的增长而呈现增长趋势。自从近50年前进行了第一个膝关节置换术至今,针对人工膝关节的设计不断改进,手术技术也取得了很大突破。我们必须确保病患使用膝关节植入物的安全性,因此对膝关节新的设计和材料的验证测试仍然是至关重要的。 


Orthotek提供整体膝关节和部分膝关节置换测试服务。常见的测试包括疲劳测试,磨损测试,接触压力测试,约束测试和腐蚀测试,以及多孔涂层评价和外植体失效分析。

髌骨规格


ASTM F 1672: Standard Specification for Resurfacing Patellar Prosthesis.

人工膝关节分类与规格


ISO 7207-1: Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions.

ISO 7207-2: Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastic materials.

ISO 21536: Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants.

人工膝关节磨损测试


ISO 14243-1: Implants for surgery -- Wear of total knee joint prostheses
Part 1:Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for tests.

ISO 14243-2: Implants for surgery -- Wear of total knee joint prostheses Part 2: Methods of measurement.

ISO 14243-3: Implants for surgery — Wear of total knee joint prostheses, Part 3: Loading and displacement parameters for wear testing machines with displacement control and corresponding environmental conditions for test.  

高屈曲疲劳测试


ASTM F2777: Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion.

人工膝关节磨损测试



ISO 14243-1: Implants for surgery -- Wear of total knee joint prostheses
Part 1:Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for tests.

ISO 14243-2: Implants for surgery -- Wear of total knee joint prostheses Part 2: Methods of measurement.

ISO 14243-3: Implants for surgery — Wear of total knee joint prostheses, Part 3: Loading and displacement parameters for wear testing machines with displacement control and corresponding environmental conditions for test.  

活动型胫骨平台疲劳测试


ASTM F2723: Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation.

ASTM F2722: Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops.

    
小关节类
创伤类
脊柱类
手术工具类
齿科类
定制测试
失效分析

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