医疗器械疲劳测试提示

疲劳试验用于在循环载荷期间表征材料性质和样本行为。了解设备的耐用性和限制允许医疗设备制造商带来安全可靠的产品。

Given the complex regulation and high risk of medical device applications, fatigue testing must be stringently performed to the appropriate stress levels, sample size, and standards according to well-defined test protocols.

如何进行医疗设备S / N疲劳测试？

医疗器械疲劳检测重点关注在许多循环后失效所需的标称应力。压力通常绘制在对数尺度上，以抵抗失败的循环次数（n），也称为S / N疲劳测试。

During an S/N fatigue test, the first sample group is tested at high peak stress (or strain in a variation of the test) where failure occurs after a low number of cycles. Subsequent samples are tested at decreasing stress levels until a statistically significant number of samples do not fail in the specified number of cycles. The fatigue threshold is the highest stress at which a runout (non-failure) occurs.

如何确定样本大小

确定适当的样本大小是最高统计置信度所需的测试数量与开发试样的成本之间的平衡。所需的样本数量取决于标准偏差和所需水平的统计显着性。电源分析计算器可在线提供，以帮助您确定应用程序的最佳示例大小。

样品和跳动整形设备疲劳Testing

Orthopedic devices experience various forces during their use inside the body, including fatigue, torsion and wear. The number of samples needed for an orthopedic device fatigue test may vary based on device type, materials and more.

例如，在骨板疲劳测试期间，通常使用六个样品。在较高的负载水平下测试4个样品以在较高的负载水平下进行故障，两者用作跳动。如果对产品或过程进行了较小的更改，则只需要重新测试跳动样本以确认更改不会影响设备性能。

血管内装置疲劳试验样品设计与故障检测方法

对于没有谓词的血管内装置测试，所需的样品计数和测试水平的数量通常比具有整形外科器件高。例如，支架设计可以使用每个测试水平的六个或十二个标本夹具。

为了在循环（n）和应力轴上达到更好的粒度，可以与每个六个或十二个样本测试设置一起使用六个或更多个测试水平。虽然测试数量可能是六个，所测试的样本数量可以是72.当测试多个样本时，掺入失效检测机制是有用的，以便可以跟踪试样故障而无需恒定的视觉检查。

用于血管内装置疲劳试验的测试试样通常是支架和阀门的菱形，并且可以直接从装置（1：1刻度）或缩放，因此如果设备尺寸非常小，则更容易处理。

元素优势

As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single source supplier for all of your testing needs, from product qualification and mechanical testing to material characterization and microbiological evaluation.

Our medical device experts work diligently to help your company mitigate risk and bring safe products to patients worldwide.联系我们to discuss how we can help with your medical device fatigue testing.

如何为医疗设备疲劳测试项目创建测试协议

为确保任何尺寸的成功疲劳测试项目，请符合清晰和彻底的测试协议，以符合清晰和彻底的测试协议进行测试至关重要。聘请专家Maciej Jakucki概述了如何构建文档，分析要求和定义我们的验收标准医疗设备的测试协议文章。

Which medical device fatigue test system should I use?

There are different systems available for fatigue testing of medical devices. While most 21st-century fatigue testing applications leverage linear motor technology, each technology possesses unique characteristics that make it indispensable to medical device testing. Our医疗器械疲劳测试系统的比较文章介绍了伺服液压，伺服喷射，单相和多相线性电机测试系统之间的差异。

Do’s and Dont’s of Medical Device Mechanical Testing

有关医疗器械的疲劳测试和机械测试程序的更多指导，请阅读我们的文章做医疗器械机械测试的事务。