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Testing 5G User Equipment: Review, Challenges, and Gaps from the Medical Device Perspective
Yongkang Liu1, Mohamad Omar Al Kalaa1
1Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA).
None:
5G technology can enable novel healthcare applications and augment existing medical device use of wireless technology to improve healthcare delivery. Having the dual role of medical device and cellular user equipment (UE), 5G-enabled devices navigate a plethora of rules and tests before they can operate on a 5G network to deliver their intended medical function. In this paper, we review the state-of-the-art of 5G UE certification programs and testing specifications. We then identify test challenges and discuss the relevance of existing test practices to support the 5G-enabled medical device safety and effectiveness. This information is useful to medical device developers planning to incorporate 5G technology in their products and wireless engineers working to expand mobile services into the healthcare vertical.
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