prEN ISO/IEEE 11073-10419

Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE FDIS 11073-10419:2026)

General information

40.20   DIS ballot initiated: 12 weeks   Jul 16, 2026

CEN

CEN/TC 251 Health informatics

European Norm

35.240.80   IT applications in health care technology

Scope

This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO/IEEE 11073-10419:2023

NOW

IN_DEVELOPMENT
prEN ISO/IEEE 11073-10419
40.20 DIS ballot initiated: 12 weeks
Jul 16, 2026