Integrating machine-readable user interface requirements into open networked operating rooms.

ABSTRACT: Comprehensive risk management (RM) and usability engineering (UE) must be performed to enable safe and usable interoperable medical device systems (according to IEEE 11073 SDC). This has to be fulfilled by applying recognized standards such as ISO 14971 (RM) and IEC 62366-1 (UE). Addressing the complexity of use cases with multiple network participants requires defining use context, hazardous situations, user profiles, user interfaces, system function contributions, limitations, configurations, and required conditions for safe use. We propose extending the categories mentioned in IEEE 11073-10700 with standardized user interface requirements provided by medical device manufacturers. A consumer of networked services can consider those UI Profiles containing design-, risk-, and

SUBMITTER: Yilmaz O 

PROVIDER: S-EPMC12319011 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature