外科植入物用α+β钛合金金相检验国内外标准对比分析
Comparative analysis of domestic and foreign standards for metallographic examination of α+β titanium alloy for surgical implants
李帆 1高娜 1张露文 1郭琳琳 1娄贵 1张博1
作者信息
- 1. 山东省医疗器械和药品包装检验研究院,山东济南 250101;国家药品监督管理局生物材料器械安全性评价重点实验室,山东济南 250101;山东省医疗器械生物学评价重点实验室,山东济南 250101
- 折叠
摘要
对比分析了国内外外科植入物标准中对钛合金显微组织的要求,GB/T 13810-2017中板材的显微组织要求原始β晶粒应充分破碎,不准许存在连续的晶界α相,棒材和丝材的显微组织应符合该标准中图A.1(a～i).ISO 5832-3、ASTM F136和ASTM F1472的最新版中都规定显微组织应为在转变β基体上分布着等轴和/或拉长的初生α相,在原始β晶界上无连续的网状α相,其中ISO 5832-3中棒材的横向显微组织还要求符合ISO 20160中的A1～A9.结合钛合金的热机械加工工艺,热加工和再结晶的温度足够低于β转变温度,或者缓慢冷却时,将得到高体积分数的初生α相和晶间β相,在接近β转变温度下进行再结晶处理,将得到转变β基体上均匀分布着的等轴初生α相,表现为标准图谱中的A1～A9.在β相转变温度以上进行再结晶处理,将得到粗大的β晶粒间存在连续的晶界α、网状α、片状α相,表现为标准图谱中的A10～A24.
Abstract
Microstructure requirements of titanium alloy in surgical implant standards in domestic and foreign were compared and analyzed.The microstructure of plates in GB/T 13810-2017 requires that the original β grain should be fully broken,and continuous grain boundary αphase is not allowed,the microstructure of bars and wires should conform to figure A.1(a-i)of the standard.The latest versions of ISO 5832-3,ASTM F136,and ASTM F1472 all specify that the microstructure shall be equiaxial and/or elongated primary α phase distributed on the transformed β matrix,with no continuous α network on the prior β grain boundaries.Among them,the transverse microstructure of the bars in ISO 5832-3 shall correspond to A1-A9 in ISO 20160.Combined with the thermal mechanical processing technology of titanium alloy,when the temperature of hot processing and recrystallization is lower than the β transition temperature,or slowly cooling,high volume fraction of primary α phase and intergranular β will be obtained,recrystallization treatment at close to the β transition temperature will obtain equiaxial primary α phase uniformly distributed on the β matrix,which is represented by A1-A9 in the standard spectrum.After recrystallization above the β phase transition temperature,continuous grain boundary α,network α and lamellar α phases are obtained between the coarse β grains,which are manifested as A10-A24 in the standard diagram.
关键词
TC4合金/显微组织/国内外标准/热处理Key words
TC4 alloy/microstructure/domestic and foreign standards/heat treatment引用本文复制引用
基金项目
山东省医疗器械和药品包装检验研究院内部立项项目(NB202311)
出版年
2024
NETL
NSTL
万方数据