EN ISO/IEEE 11073-10419:2023 PDF

Overview

EN ISO/IEEE 11073-10419:2023 (equivalent to ISO/IEEE 11073-10419:2019) is the CEN-adopted device specialization standard for insulin pumps within the ISO/IEEE 11073 family. It provides a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (for example, smartphones, personal computers, personal health appliances or set‑top boxes) to enable plug-and-play interoperability in telehealth environments. The standard defines a common core of communication functionality and the data modelling approach according to ISO/IEEE 11073-20601. It does not specify measurement methods for insulin delivery.

Key topics and technical requirements

• Plug-and-play interoperability: Normative rules for agent (pump) and manager behavior to support seamless device discovery and data exchange.
• Data modelling: Uses the ISO/IEEE 11073-20601 information model for consistent representation of device data and states.
• Restricted optionality: Limits optional features of base frameworks to ensure interoperable implementations across vendors.
• Terminology and term codes: Specifies the use of established ISO/IEEE 11073 term codes, formats and semantics rather than introducing new measurement methods.
• Profiles leveraged: Applies existing 11073 terminology, information profiles, application profile standards and transport standards to insulin pump specialization.
• Core functionality definition: Defines a minimum set of behaviors, events and data items expected from personal telehealth insulin pumps (CSII devices).

Applications and practical value

• Enables reliable wireless/data communication between insulin pumps and mobile apps, gateways and health IT systems for remote monitoring, telemedicine and patient self‑management.
• Facilitates integration of pump data into electronic health records (EHRs), personal health records (PHRs) and cloud analytics platforms.
• Reduces integration cost and time for developers and integrators by providing a standard semantic model and expected behaviors.
• Supports device manufacturers in producing interoperable pumps and managers, and helps test labs and certification bodies evaluate conformance.

Who should use this standard

• Medical device manufacturers (insulin pump and accessory vendors) implementing device communications.
• mHealth and telehealth application developers and system integrators connecting pumps to smartphones, gateways or cloud services.
• Healthcare IT architects, interoperability specialists and regulatory bodies interested in medical device communication standards.
• Test laboratories and certification bodies performing conformance and interoperability testing.

Related standards

• ISO/IEEE 11073-20601 (agent/manager data model) - used for data modelling.
• Other parts of the ISO/IEEE 11073 family for terminology, transport and application profiles.

Keywords: EN ISO/IEEE 11073-10419:2023, insulin pump, personal health device communication, ISO/IEEE 11073, medical device communication, interoperability, CSII, data modelling.