IEEE 2802-2022
IEEE Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology
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About This Item
IEEE 2802-2022 is a technical standard focused on the terminology used for performance and safety evaluation of artificial intelligence based medical devices. It helps align understanding across bioengineering, computing, communication, and device engineering contexts where consistent language is essential for assessment and documentation. By defining terms for this specialized area, the standard supports clearer communication between developers, testers, reviewers, and procurement teams working with AI-enabled medical technology.
IEEE 2802-2022 overview
This standard provides terminology for evaluating the performance and safety of artificial intelligence based medical devices, helping reduce ambiguity in a complex technical area. In practice, IEEE 2802-2022 supports consistent use of terms when describing system behavior, test results, risk-related considerations, and device capabilities. It is relevant to engineering teams and organizations that need a common vocabulary for specification writing, verification, and technical review of AI-enabled medical systems.
Typical use cases
IEEE 2802-2022 is useful when documenting or reviewing AI-based medical devices that rely on software, data processing, networking, or integrated electronic systems. It may be applied in design documentation, performance evaluation reports, safety assessments, and supplier or procurement specifications. The terminology can also support multidisciplinary teams working on diagnostic tools, monitoring systems, connected medical equipment, or other computer-assisted healthcare technologies where precise language is important.
Why this standard matters
Clear terminology is important when safety and performance claims must be evaluated consistently across teams and organizations. IEEE 2802-2022 can help reduce misunderstandings during testing, compliance review, and technical exchange, especially where AI behavior affects medical device outcomes. For organizations involved in development, validation, or purchasing, the standard supports more reliable comparisons, better documentation quality, and lower risk of inconsistent interpretation in engineering and regulatory workflows.
- Terminology for AI-based medical device evaluation
- Performance and safety assessment language
- Useful for testing and documentation
- Supports engineering and review consistency
- Relevant to connected medical systems
- Publication Date: 2023
- Standard Status: Active
- Publisher: IEEE
- Subject: Bioengineering; Components, Circuits, Devices and Systems; Computing and Processing; Communication, Networking and Broadcast Technologies
- Official IEEE: Doi link
- This Version: 2802 (2023)
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