T/GMES 029-2024 TiNi shape memory alloy internal fixation device

Scope

Main technical contents: 4.3 Performance 4.3.1 Hardness: The hardness of internal fixation devices shall meet the manufacturer's specified requirements. 4.3.2 Shape recovery rate: The shape recovery rate of internal fixation devices shall be no less than 95%. 4.3.3 Phase transition temperature: The effective austenite phase transition completion temperature of internal fixation devices shall meet the manufacturer's specified requirements. 4.3.4 Shape recovery force: The shape recovery force of internal fixation devices shall meet the manufacturer's specified requirements. 4.3.5 Static mechanical properties: The bending structure stiffness and bending strength of internal fixation devices shall meet the manufacturer's specified requirements. 4.3.6 Fatigue performance: The fatigue strength under a 106-cycle load condition shall meet the manufacturer's specified requirements. 4.4 Surface quality 4.4.1 Surface defects: The surface defects of internal fixation devices shall comply with the requirements of YY 0017. 4.4.2 Surface roughness: The surface roughness Ra value of internal fixation devices shall not exceed the values specified in Table 1. 4.4.3 Appearance: The surface shall be smooth, without defects such as sharp edges, burrs, or adhered materials. 4.5 Biological evaluation: Conduct a biological evaluation according to GB/T 16886.1, and the results shall be within acceptable levels. 4.6 Nickel ion release: The manufacturer shall evaluate the nickel ion release of internal fixation devices. 4.7 Sterility: Internally fixed devices delivered in a sterile state shall undergo an effective and validated sterilization process to ensure their sterility. 4.8 Ethylene oxide residue: If internal fixation devices are sterilized with ethylene oxide, the ethylene oxide residue shall meet the manufacturer's specified requirements and not exceed the values specified in GB/T 16886.7.

Development Information

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