外科植入物用α+β钛合金金相检验国内外标准对比分析

doi:10.13251/j.issn.0254-6051.2024.06.043

金属热处理 ›› 2024, Vol. 49 ›› Issue (6): 277-281.DOI: 10.13251/j.issn.0254-6051.2024.06.043

外科植入物用α+β钛合金金相检验国内外标准对比分析

李帆^1,2,3, 高娜^1,2,3, 张露文^1,2,3, 郭琳琳^1,2,3, 娄贵^1,2,3, 张博^1,2,3

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

收稿日期:2023-11-12 修回日期:2024-03-19 出版日期:2024-06-25 发布日期:2024-07-29
通讯作者: 张博,高级工程师,硕士,E-mail:zhang_bo51@126.com
作者简介:李帆(1992—),男,工程师,硕士,主要研究方向为无源医疗器械物理性能检测,E-mail:lifanqust@163.com。
基金资助:
山东省医疗器械和药品包装检验研究院内部立项课题(NB202311)

Comparative analysis of domestic and foreign standards for metallographic examination of α+β titanium alloy for surgical implants

Li Fan^1,2,3, Gao Na^1,2,3, Zhang Luwen^1,2,3, Guo Linlin^1,2,3, Lou Gui^1,2,3, Zhang Bo^1,2,3

1. Shandong Provincial Key Laboratory of Biological Evaluation of Medical Devices, Jinan Shandong 250101, China;
2. Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA, Jinan Shandong 250101, China;
3. Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, Jinan Shandong 250101, China

Received:2023-11-12 Revised:2024-03-19 Online:2024-06-25 Published:2024-07-29

摘要/Abstract

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。

关键词: TC4合金, 显微组织, 国内外标准, 热处理

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 α phase 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.

Key words: TC4 alloy, microstructure, domestic and foreign standards, heat treatment

中图分类号:

TG113

李帆, 高娜, 张露文, 郭琳琳, 娄贵, 张博. 外科植入物用α+β钛合金金相检验国内外标准对比分析[J]. 金属热处理, 2024, 49(6): 277-281.

Li Fan, Gao Na, Zhang Luwen, Guo Linlin, Lou Gui, Zhang Bo. Comparative analysis of domestic and foreign standards for metallographic examination of α+β titanium alloy for surgical implants[J]. Heat Treatment of Metals, 2024, 49(6): 277-281.

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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

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