Health Informatics - Device Interoperability - Part 10406: Device specialization - Personal health device communication, device specialization, basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE FDIS 11073-10406:2026); English version prEN ISO/IEEE 11073-10406:2026
Abstract
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set-top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and ISO/IEEE 11073-206016 information models. 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 of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate).
Begin
2026-06-03
WI
00251441
Planned document number
DIN EN ISO/IEEE 11073-10406
Project number
17600238
Responsible national committee
NA 176-02-02 AA - Interoperability
Responsible european committee
CEN/TC 251/WG 2 - Technology and Applications
Responsible international committee
ISO/TC 215/WG 2 - Systems and Device Interoperability
draft standard
Health Informatics - Device Interoperability - Part 10406: Device specialization - Personal health device communication, device specialization, basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE FDIS 11073-10406:2026); English version prEN ISO/IEEE 11073-10406:2026
2026-08
Order from DIN Media
