摘要
目的:以完善镍钛形状记忆合金材料和植入物的安全有效性标准评价体系为目的,指明我国在该领域的标准化研究方向。方法:一方面,对比国内外在相关领域已发布的标准与相关材料产品安全有效性评价的标准需求之间的差距;另一方面,对比国内外标准在具体技术内容上的区别。通过对比总结出我国在此领域应该重点开展的标准化研究方向。结果:在医用镍钛形状记忆合金材料及其植入物领域,国际上已有美国等5个国家的标准化组织发布了25份专用标准,我国已发布了11份专用标准,基本形成了比较完善的标准体系。通过对国内外发布标准技术内容的比较,可发现我国在医用镍钛合金电偶腐蚀性能评价、相转变温度测试方法的标准相对滞后于国际标准。另外,通过分析对比镍钛形状记忆合金材料及其植入物安全有效性评价的标准需求,可发现在医用镍钛形状记忆合金材料或植入物体外镍离子释放、镍钛形状记忆合金植入物的形状恢复能力评价等方面,国内外均缺少规范的标准。结论:我国应在相关方面尽快开展标准化研究,积极缩小国内外标准差距,进一步完善镍钛合金材料和植入物的安全性和有效性标准评价体系,为企业的质量控制提供依据,为监管部门的技术审评提供指南,更好地保障人民群众的用械安全。
Objective:To point out the standardization research direction of our country in this field with the aim of improving the standard evaluation system of safety and effectiveness of nickel-titanium shape memory alloy materials and implants.Methods:On the one hand,the gap between published standards in the related field at home and abroad and the standard requirements for safety and effectiveness evaluation of related materials and products was compared.On the other hand,the differences between domestic and foreign standards in the specific technical content were compared.The standardization research direction our country should focus on in this field was summarized through these comparisons.Results:In the field,25 specialized standards have been issued in the world by standardization organizations in 5 countries including the United States and 11 specialized standards have been issued in China.Therefore,a relatively perfect standard system has been basically formed.By comparing the technical content of standards issued at home and abroad,we find out that the standards of evaluation of galvanic corrosion performance and test methods of phase inversion temperature of medical nickeltitanium alloy in China lag behind the international standards.In addition,by analyzing and comparing the standard requirements of the safety and effectiveness evaluation of nickel-titanium shape memory alloy materials and their implants,we also find out that there is a lack of standard standards at home and abroad in the following aspects,such as in vitro release of nickel ions from medical NiTi shape memory alloy materials or implants,the evaluation of the shape recovery ability of nickel-titanium shape memory alloy materials or implants and so on.Conclusion:China should carry out standardized research as soon as possible in relevant aspects,and actively narrow the standard gap between China and foreign countries,and further improve the standard evaluation system for the safety and effectiveness of nickel-titanium alloy materials and their implants to provide a basis for the quality control of enterprises,to provide guidance for the technical review of regulatory departments,and to better ensure the safety of the people using medical devices.
作者
汤京龙
马立翠
温莉茵
徐红
宋可婧
吕原原
余新华
母瑞红
Tang Jinglong;Ma Licui;Wen Liyin;Xu Hong;Song Kejing;Lv Yuanyuan;Yu Xinhua;Mu Ruihong(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国药事》
CAS
2019年第6期649-654,共6页
Chinese Pharmaceutical Affairs
基金
国家重点研发计划课题(编号2018YFC1106704)
关键词
镍钛
形状记忆
标准
合金
Nickel titanium
shape memory
standard
alloy
