医疗器械EMC风险管理中如何评估EMC风险可接受性标准

IF 0.9 Q4 ENGINEERING, ELECTRICAL & ELECTRONIC
Vikas Ghatge;Dries Vanoost;Rob Kleihorst;Davy Pissoort
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引用次数: 0

摘要

电磁干扰(EMI)风险是所有电子设备故障的潜在原因之一。因此,在电磁兼容性(EMC)风险管理过程开始时定义emi风险可接受准则(EMI-RAC)以确定要实现的可接受风险水平是至关重要的。然而,定义这些标准是复杂的,因为它们依赖于各种因素,例如法规、标准、最先进的(SOTA)实践、参考数据库和专家判断。因此,这封信讨论了如何区分定义EMI-RAC的可接受,可容忍和不可接受的风险边界和区域。这封信通过简单的轶事例子为制造商提供了实用指南,其中业务目标被系统地转化为技术可接受性标准,并最终转化为可验证的EMC测试性能标准。它还说明了制造商如何在医疗器械设计中代表标准并平衡风险降低,以管理电磁干扰风险。这是通过风险效益分析和SOTA解决方案实现的,同时避免了现场故障和声誉损害。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
How to Assess EMI-Risk Acceptability Criteria in Medical Device EMC Risk Management
Electromagnetic-interference (EMI) risks are among the potential causes of failure in all electronic equipment. Therefore, it is crucial to define EMI-risk acceptability criteria (EMI-RAC) at the beginning of the electromagnetic-compatibility (EMC) risk management process to decide the acceptable risk levels to be achieved. However, defining these criteria is complex due to their dependence on various factors, such as regulations, standards, state-of-the-art (SOTA) practices, reference databases, and expert judgment. Therefore, this letter discusses how to distinguish acceptable, tolerable, and unacceptable risk boundaries and regions that define EMI-RAC. This letter provides practical guidelines for manufacturers through simple anecdotal examples where the business objectives are systematically transformed into technical acceptability criteria and eventually into verifiable EMC testing performance criteria. It also illustrates how manufacturers can represent criteria and balance risk reduction in medical device design to manage EMI risks. This is achieved in relation to risk-benefit analysis and SOTA solutions while avoiding field failures and damage to reputation.
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