IEEE/UL 2621.1:2022

IEEE/UL Standard for Wireless Diabetes Device Security Assurance Evaluation: Connected Electronic Product Security Evaluation Programs

Standard Details

Committee/Society: IEEE Engineering in Medicine and Biology Society/StandardDetails Committee

Abstract: A framework for a connected electronic product security assurance evaluation program, with specific requirements and guidance relating to digital diabetes devices and solutions, such as insulin pumps is described in this standard.

Keywords: assurance, diabetes, devices, evaluator, firmware, IEEE 2621.1, protection profile, security, security target

Multimedia: N

Additional Comments: Title and Designation Updated

Subscription Package: Digital Health

Non-IEEE Normative references: ISO/IEC 15408-1--Information technology--Security techniques--Evaluation criteria for IT security--Part 1: Introduction and general model.

ISO/IEC 15408-2--Information technology--Security techniques--Evaluation criteria for IT security--Part 2: Security functional components.

ISO/IEC 15408-3--Information technology--Security techniques--Evaluation criteria for IT security--Part 3: Security assurance components.

ISO/IEC 17025, Testing and calibration laboratories. ISO/IEC 18045, Information technology--Security techniques--Methodology for IT security evaluation.