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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.