Al Kalaa Mohamad Omar, Guag Joshua, Seidman Seth J, Ma Yao, Coder Jason
Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD 20993.
National Institute of Standards and Technology (NIST), Boulder, CO 80305.
IEEE Electromagn Compat Mag. 2020;9(4):47-53. doi: 10.1109/memc.2020.9328232.
This article aims to provide a narrative for addressing wireless coexistence in medical devices to help medical device developers, test engineers, and regulatory affairs personnel throughout the device life cycle. Accordingly, we present a case-study covering the coexistence evaluation process including the risk analysis of the wireless functionality of a hypothetical medical device, determining the corresponding risk category, specification of the device functional wireless performance (FWP), wireless coexistence testing, and measurement of the intended/untended signal ratio. Also, we propose a simple method for translating the test outcome into user recommendations for minimum/maximum separation distances between the device, its intended companion, and the source of unintended signals.
本文旨在提供一个关于解决医疗设备中无线共存问题的叙述，以帮助医疗设备开发者、测试工程师以及整个设备生命周期中的监管事务人员。因此，我们呈现了一个案例研究，涵盖共存评估过程，包括对一个假设医疗设备的无线功能进行风险分析、确定相应的风险类别、规定设备功能无线性能（FWP）、进行无线共存测试以及测量预期/非预期信号比。此外，我们还提出了一种简单方法，可将测试结果转化为针对设备、其预期配套设备以及非预期信号源之间最小/最大分离距离的用户建议。
