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​          脊柱类



脊柱内固定组件规格


ASTM F 2193: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.



脊柱椎体融合器静态及疲劳测试



ASTM F 1798: Evaluation of the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants.


ISO 12189: Implants for surgery — Mechanical testing of implantable spinal devices — Fatigue test method for spinal implant assemblies using an anterior support.


脊柱植入物










脊柱植入物是生物医药行业增长最快的领域之一，随着新型设备的不断开发，其应用将继续增长态势。


Orthotek拥有良好的测试设备与分析手段，可以满足客户对脊柱装置的测试要求。


脊柱植入物一般分为融合或非融合装置。Orthotek对于这两种类型的脊柱植入物都可以根据ASTM标准如ASTM F1717和ASTM F2077等提供测试服务​。

脊柱内固定钉棒系统测试



ASTM F 1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.


椎间融合器测试方法



ASTM F 2077: Test Methods For Intervertebral Body Fusion Devices.


人工椎间盘磨损测试


ISO 18192-1: Test Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test.

ISO 18192-2: Implants for surgery — Wear of total spinal intervertebral disc prostheses — Part 2: Nucleus replacements.

静力作用下椎间融合器塌陷测试



ASTM F 2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.


其他测试​



ASTM F 2624: Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants.


ASTM F 2694: Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses.

ASTM F 2790: Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses.


ASTM F 2706: Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. 



    
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