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The effect of fatigue on the corrosion resistance of common medical alloys

机译：疲劳对普通医用合金耐蚀性的影响

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The effect of mechanical fatigue on the corrosion resistance of medical devices has been a concern for devices that experience significant fatigue during their lifespan and devices made from metallic alloys. The Food and Drug Administration had recommended in some instances for corrosion testing to be performed on post-fatigued devices [Non-clinical tests and recommended labeling for intravascular stents and associated delivery systems: guidance for industry and FDA staff. 2005: Food and Drug Administration, Center for Devices and Radiological Health], although the need for this has been debated [Nagaraja S, et al., J Biomed Mater Res Part B: Appl Biomater 2016, 8.] This study seeks to evaluate the effect of fatigue on the corrosion resistance of 5 different materials commonly used in medical devices: 316 LVM stainless steel, MP35N cobalt chromium, electropolished nitinol, mechanically polished nitinol, and black oxide nitinol. Prior to corrosion testing per ASTM F2129, wires of each alloy were split into subgroups and subjected to either nothing (that is, as received); high strain fatigue for less than 8 min; short-term phosphate buffered saline (PBS) soak for less than 8 min; low strain fatigue for 8 days; or long-term PBS soak for 8 days. Results from corrosion testing showed that the rest potential trended to an equilibrium potential with increasing time in PBS and that there was no statistical (p >0.05) difference in breakdown potential between the fatigued and matching PBS soak groups for 9 out of 10 test conditions. Our results suggest that under these nonfretting conditions, corrosion susceptibility as measured by breakdown potential per ASTM F2129 was unaffected by the fatigue condition.
机译：机械疲劳对医疗器械的耐腐蚀性的影响一直困扰着在其使用寿命中遭受严重疲劳的器械以及由金属合金制成的器械。在某些情况下，美国食品药品监督管理局（FDA）建议对疲劳后的设备进行腐蚀测试[非临床测试，并建议为血管内支架和相关的输送系统贴标签：针对行业和FDA工作人员的指南。 2005：食品和药物管理局，设备与放射卫生中心]，尽管对此的争议已经讨论过[Nagaraja S等人，J Biomed Mater Res Part B：Appl Biomater 2016，8。]本研究旨在评估疲劳对医疗设备中常用的5种不同材料的耐腐蚀性的影响：316 LVM不锈钢，MP35N钴铬，电抛光的镍钛合金，机械抛光的镍钛合金和黑色氧化镍钛合金。在按照ASTM F2129进行腐蚀测试之前，将每种合金的线分成亚组，不进行任何处理（即按原样）；不到8分钟的高应变疲劳；短期磷酸盐缓冲盐水（PBS）浸泡少于8分钟； 8天低疲劳疲劳；或长期PBS浸泡8天。腐蚀试验的结果表明，在PBS中，随着时间的延长，静息电位趋于平衡，并且在10个测试条件中的9个中，疲劳和匹配的PBS浸泡组之间的击穿电位没有统计学差异（p> 0.05）。我们的结果表明，在这些微动条件下，按照ASTM F2129通过击穿电位测量的腐蚀敏感性不受疲劳条件的影响。

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