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Radiofrequency identification and medical devices: The regulatory framework on electromagnetic compatibility. Part II: Active implantable medical devices

机译:射频识别和医疗设备:电磁兼容性的监管框架。第二部分:有源植入式医疗设备

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摘要

The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology.
机译:在过去的十年中,具有有源可植入医疗设备(AIMD)的患者在日常活动中所接触的电磁辐射器的数量和类型激增。射频识别(RFID)是在许多领域中应用的无线技术的一个示例。 RFID发射器与AIMD之间的相互作用对于患者,行业和监管机构而言是一个重要的问题,因为与此类相互作用相关的风险。不同的AIMD引用以不同方式解决电磁抗扰性问题的不同标准。实际上,使用了不同的测试设置,免疫级别和原理来确保AIMD对电磁非电离辐射具有免疫力。在本文中,分析了有关RFID系统与AIMD之间电磁兼容性的法规框架,以了解当前AIMD标准的应用是否以及如何应用才能有效控制与RFID技术相关的潜在风险。

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