镍钛形状记忆合金内固定器械标准的发展现状  

Development Status of Nickel Titanium Shape Memory Alloy Internal Fixation Device Standards

作　　者：聂永胜 张镭 闫鹏伟 宋丽霞 陈大雷 高海艳 王毅博 贺军权 缪祥文 胡亚平 Nie Yongsheng;Zhang Lei;Yan Pengwei;Song Lixia;Chen Dalei;Gao Haiyan;Wang Yibo;He Junquan;Miao Xiangwen;Hu Yaping(Lanzhou Seemine Shape Memory Alloy Co.,Ltd.,Lanzhou Gansu 730105,China;Gansu Medical Device Inspection and Testing Institute,Lanzhou Gansu 730000,China;Qingyang City Ecological Environment Protection Bureau,Gansu Province,Qingyang Gansu 745000,China)

机构地区：[1]兰州西脉记忆合金股份有限公司,甘肃兰州730105 [2]甘肃医疗器械检验检测所,甘肃兰州730000 [3]甘肃省庆阳市生态环境保护局,甘肃庆阳745000

出　　处：《医疗装备》2024年第3期22-26,共5页Medical Equipment

基　　金：甘肃省药品科研项目(2021GSMPA004)。

摘　　要：镍钛形状记忆合金因具有优越的反复使用稳定性、超弹性、低杨氏模量、生物体适应性、耐腐蚀性,被广泛用于制造医疗器械。该研究通过介绍政府相关部门已颁布的与镍钛形状记忆合金内固定器械紧密相关的标准内容,分析标准的特点和不足。结果显示,镍钛合金骨板的标准体系较完善、健全和清晰;对于规范镍钛合金骨科内植入器械的生产、检测、使用和产品质量都具有较高的使用价值,但存在产品标准跟不上产品研发的步伐、标准门槛较低、对产品标准实施力度不够、性能评估不全面和安全性评估不充分等问题。因此,应根据现有工艺技术水平不断提高镍钛形状记忆合金内固定器械标准参数和技术指标,加强行业标准协同制定和人才队伍建设,从而推动镍钛形状记忆合金内固定器械的发展和产品质量的提高。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.

关 键 词：形状记忆合金 内固定器械 标准 超弹性 

分 类 号：R318.08[医药卫生—生物医学工程]