Scholarlink

<p>The in vitro pitting corrosion acceptance criteria for ASTM F2129 testing that represents safe long-term in vivo performance of medical devices has been a subject of discussion for decades in the community. Most studies in this area point to low <i>E</i><sub>b</sub> values (i.e., &lt; 300&#xa0;mV) as concerning to long-term in vivo performance and typically, Ni-elution testing (ASTM F3306) is recommended to further understand a device’s corrosion performance. To investigate the relationship between F2129 and F3306 test methods, nitinol samples representing low <i>E</i><sub>b</sub> values were manufactured. F2129 testing was conducted on as-manufactured samples and samples incubated at relevant F3306 time points. Another set of samples underwent metal ion elution testing. The as-made average <i>E</i><sub>b</sub> values for the three groups were − 64, 76, and 213&#xa0;mV vs. SCE. All groups saw an increase in <i>E</i><sub>b</sub> and <i>E</i><sub>b</sub>–<i>E</i><sub>r</sub> with incubation time. The group with an as-made <i>E</i><sub>b</sub> of − 64&#xa0;mV vs. SCE showed the highest ion elution and visual inspection showed evidence of pitting, despite the elution values being below the recommended tolerable intakes for nickel. Even with the as-made <i>E</i><sub>b</sub> less than 300&#xa0;mV vs. SCE, the two remaining groups showed no evidence of pitting after ion elution testing or incubation.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Understanding Pitting Corrosion Acceptance Criteria Using Hybrid ASTM F2129 and ASTM F3306

  • 期刊论文

  • 发表日期：

    2025年8月21日

查看全文
  • Audrey Martin,
  • Parikshith Kumar

摘要

The in vitro pitting corrosion acceptance criteria for ASTM F2129 testing that represents safe long-term in vivo performance of medical devices has been a subject of discussion for decades in the community. Most studies in this area point to low Eb values (i.e., < 300 mV) as concerning to long-term in vivo performance and typically, Ni-elution testing (ASTM F3306) is recommended to further understand a device’s corrosion performance. To investigate the relationship between F2129 and F3306 test methods, nitinol samples representing low Eb values were manufactured. F2129 testing was conducted on as-manufactured samples and samples incubated at relevant F3306 time points. Another set of samples underwent metal ion elution testing. The as-made average Eb values for the three groups were − 64, 76, and 213 mV vs. SCE. All groups saw an increase in Eb and Eb–Er with incubation time. The group with an as-made Eb of − 64 mV vs. SCE showed the highest ion elution and visual inspection showed evidence of pitting, despite the elution values being below the recommended tolerable intakes for nickel. Even with the as-made Eb less than 300 mV vs. SCE, the two remaining groups showed no evidence of pitting after ion elution testing or incubation.