非脊柱用金属接骨螺钉及垫圈产品FDA注册性能检测

该指南适用于非脊柱用金属接骨螺钉及垫圈产品，属第II类器械，对应产品代码分别为HWC和HTN。用于下颌、颌面、颅骨和眼眶骨折内固定或用于脊柱的接骨螺钉或垫圈不在本指南适用范围内。用于缝合或弦状结构（如骨锚、韧带联合紧绳）作为植入系统一部分的产品也不在本指南适用范围内。各种型号的接骨螺钉(例如松质骨螺钉、皮质骨螺钉、空心螺钉、全螺纹螺钉、半螺纹螺钉)都在本指南适用范围内。组成该类产品的接骨螺钉和垫圈，其材料需为符合下列FDA认可标准中的任意一种：

●ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

●ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

●ASTM F1295 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

●ASTM F67 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

●ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

●ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

●ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

需进行的性能测试及标准如下：

力学测试

●扭转强度

方法：ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws

●转动扭矩

方法：ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws

●轴向拔出力

方法：建议使用Chapman等人在1996年所提出的方程进行工程分析，以评估轴向拔出力。

灭菌(标记为无菌的器械)和再处理(终端用户灭菌)验证

●灭菌(标记为无菌的器械)和再处理(终端用户灭菌)

方法：FDA目前认可的以下共识标准版本(如适用)：

●International Organization for Standardization (ISO) 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

●ISO 11135-1 Sterilization of health care products – Ethylene oxidePart 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

●ISO 11137-1 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

●ISO 11607-1 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

●ISO 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes

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