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 ofα+βtitanium alloy for surgical implants

作　　者：李帆 高娜 张露文 郭琳琳 娄贵 张博 Li Fan;Gao Na;Zhang Luwen;Guo Linlin;Lou Gui;Zhang Bo(Shandong Provincial Key Laboratory of Biological Evaluation of Medical Devices,Jinan Shandong 250101,China;Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,NMPA,Jinan Shandong 250101,China;Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,山东济南250101 [2]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 [3]山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《金属热处理》2024年第6期277-281,共5页Heat Treatment of Metals

基　　金：山东省医疗器械和药品包装检验研究院内部立项课题(NB202311)。

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。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 originalβgrain should be fully broken,and continuous grain boundaryαphase 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 primaryαphase distributed on the transformedβmatrix,with no continuousαnetwork on the priorβgrain 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 theβtransition temperature,or slowly cooling,high volume fraction of primaryαphase and intergranularβwill be obtained,recrystallization treatment at close to theβtransition temperature will obtain equiaxial primaryαphase uniformly distributed on theβmatrix,which is represented by A1⁃A9 in the standard spectrum.After recrystallization above theβphase transition temperature,continuous grain boundaryα,networkαand lamellarαphases are obtained between the coarseβgrains,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 

分 类 号：TG113[金属学及工艺—物理冶金]