IEEE 2621.3-2022 /UL 2621-3-2022 PDF
This recommended practice specifies recommendations for the use of consumer mobile devices (CMDs) in the control of diabetes-related medical devices. While these recommendations may be applied to other medical use cases, they are targeted specifically for diabetes related control use cases. The following two use cases are covered by this recommended practice: open loop remote control and automated insulin dosing (AID) systems. In general, the recommendations within this recommended practice apply to both use cases unless explicitly indicated otherwise.
This recommended practice defines recommendations for the use of mobile devices in diabetes contexts, as deemed necessary and sufficient by an appropriate set of stakeholders. These recommendations are intended to be used within a security evaluation program, as defined in other components of this multi-part standard.
New IEEE Standard – Active. A framework for a connected electronic product security evaluation program, with specific requirements and guidance relating to digital diabetes devices and solutions, such as insulin pumps is defined in this standard.
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