Testing 5G User Equipment: Review, Challenges, and Gaps from the Medical Device Perspective.

Area of Science:

• Biomedical Engineering
• Wireless Communications
• Regulatory Science

Background:

• 5G technology integration into medical devices presents unique regulatory and technical challenges.
• Medical devices functioning as cellular user equipment (UE) must meet stringent network and safety standards.
• The convergence of healthcare and telecommunications necessitates a review of current 5G certification processes.

Purpose of the Study:

• To review the current state-of-the-art in 5G user equipment (UE) certification programs and testing specifications.
• To identify specific challenges in testing 5G-enabled medical devices.
• To assess the relevance of existing test practices for ensuring the safety and effectiveness of these devices.

Main Methods:

• Literature review of 5G UE certification programs.
• Analysis of existing wireless testing specifications.
• Identification and discussion of test challenges for 5G medical devices.

Main Results:

• Current 5G UE certification programs and testing specifications are evolving.
• Several test challenges specific to 5G-enabled medical devices have been identified.
• The applicability of existing test practices to ensure medical device safety and effectiveness requires further evaluation.

Conclusions:

• Navigating 5G network rules and tests is crucial for 5G-enabled medical devices.
• Addressing identified test challenges is essential for the successful deployment of 5G in healthcare.
• This review provides valuable insights for developers and engineers in the 5G healthcare vertical.