Kalaa Mohamad Omar Al, Seidman Seth J, Witters Donald, Refai Hazem H
Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.
Department of Electrical and Computer Engineering, University of Oklahoma, Tulsa, OK 74135.
IEEE Electromagn Compat Mag. 2017 Fourth Quarter;6(4):47-52. doi: 10.1109/memc.0.8272281.
Integrating wireless technology in medical devices has proved beneficial for both patients and caregivers. However, the use of shared, unlicensed spectrum bands by both medical and non-medical wireless devices has raised concerns about wireless coexistence. The challenge of incorporating wireless communication into a medical device is to ensure reasonable medical device effectiveness and patient safety. Consequently, work to develop a standardized process to assess wireless coexistence, primarily for wireless medical devices, was carried by Subcommittee 7 of American National Standards Institute (ANSI)-accredited standards committee (ASC) C63 and the Wireless Working Group (SM-WG06) of the Association for the Advancement of Medical Instrumentation (AAMI). Both groups have recently released their respective documents. In this article, we discuss practical aspects of wireless coexistence testing-in the realm of ANSI C63.27 and AAMI TIR69-to help answer basic, yet important, questions such as what to test, how to test, and how to present results.
事实证明,将无线技术集成到医疗设备中对患者和护理人员都有益处。然而,医疗无线设备和非医疗无线设备都使用共享的、未经许可的频谱频段,这引发了对无线共存的担忧。将无线通信纳入医疗设备面临的挑战是确保医疗设备具有合理的有效性和患者安全。因此,美国国家标准学会(ANSI)认可的标准委员会(ASC)C63的第7小组委员会以及医疗仪器促进协会(AAMI)的无线工作组(SM-WG06)开展了工作,以制定一个主要针对无线医疗设备评估无线共存的标准化流程。这两个小组最近都发布了各自的文件。在本文中,我们将讨论在ANSI C63.27和AAMI TIR69领域进行无线共存测试的实际问题,以帮助回答一些基本但重要的问题,比如测试什么、如何测试以及如何呈现结果。