Development Status of Nickel Titanium Shape Memory Alloy Internal Fixation Device Standards
With superior repeated use stability,super elasticity,low Young's modulus,biological adaptability,and corrosion resistance,nickel titanium shape memory alloys are widely used in the manufacturing of medical devices.In this study,the characteristics and shortcomings of the standards closely related to nickel titanium shape memory alloy internal fixation devices that have been issued and formulated in China were analyzed one by one by introducing the content of the standards.The results showed that the standard system for nickel titanium alloy bone plates was relatively complete,perfect,and clear.The standards have high practical value in regulating the production,testing,use,and product quality of nickel titanium alloy orthopedic implants,but there are problems such as product standards not keeping up with the pace of product development,low standard thresholds,insufficient implementation of product standards,incomplete performance evaluation,and insufficient safety evaluation.Therefore,China should continuously improve the standard parameters and technical indicators of nickel titanium shape memory alloy internal fixation devices based on the existing technological level,strengthen the collaborative formulation of industry standards and the construction of talent teams,in order to promote the development of nickel titanium shape memory alloy internal fixation devices and improve product quality.
万方数据
维普
