ISO/IEEE FDIS 11073-10406

• Abstract:

  Within the context of the ISO/IEEE 11073 family of standards for device communication, 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 is established in ISO/IEEE11073-10406:2012. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena. ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate).

• Status: Not Published
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 2 - Systems and Device Interoperability
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 14-Jul-2026
• Completion Date: 14-Jul-2026

• Revises: ISO/IEEE 11073-10406:2012 - Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
• Effective Date: 16-May-2026

Overview

ISO/IEEE FDIS 11073-10406: Health Informatics-Device Interoperability-Part 10406: Personal Health Device Communication, Device Specialization, Basic Electrocardiograph (ECG) (1- to 3-lead ECG) establishes international requirements for communication between personal, basic ECG devices and manager systems. This standard is part of the ISO/IEEE 11073 family, which focuses on health device interoperability, ensuring plug-and-play integration of personal health devices such as wearables, smartphones, PCs, and set-top boxes. By leveraging established terminology and information models from ISO/IEEE 11073 and IEEE 11073-20601, the standard enables manufacturers and solution providers to implement interoperable ECG data exchange in telehealth environments.

This standard specifically covers personal 1- to 3-lead ECG devices used for monitoring purposes and does not extend to diagnostic ECG equipment that require the capability to annotate or analyze cardiac phenomena. Interoperability, streamlined data formats, and defined communication protocols are emphasized to promote consistent and reliable telehealth services.

Key Topics

• Plug-and-play interoperability: Defining standard methods for ECG devices to connect and exchange information seamlessly with various health managers (e.g., smartphones, computers).
• Scope of device specialization: Focusing on basic electrocardiograph devices supporting up to three leads, typically used in personal health and wearable monitoring.
• Consistent terminology and models: Utilization of ISO/IEEE 11073 nomenclature and IEEE 11073-20601 information models for uniform data representation.
• Communication functions: Specification of a core set of data structures and message formats for personal ECG telemetry, allowing multi-function implementations (e.g., ECG plus respiration rate).
• Telehealth integration: Adaptation of codes, formats, and behaviors to maximize compatibility in remote health monitoring scenarios, reducing optionality in favor of robust interoperability.
• Updates in 2026 edition (relative to previous version):
  • Added Base-Offset-Time support
  • New standard configuration definition
  • Enhanced alignment with updated 20601 base standard
  • Expanded support for configuration profiles and nomenclature version ties

Applications

Organizations, device manufacturers, and solution developers will find ISO/IEEE 11073-10406 foundational for:

• Wearable and mobile ECG devices: Ensuring that consumer and patient monitoring ECG devices can reliably transmit waveforms and heart rate data to mobile apps, PCs, or remote care hubs.
• Telehealth and remote patient monitoring: Facilitating integrated care by allowing plug-and-play interoperability, enabling timely data access for clinicians and caregivers.
• Healthcare IoT platforms: Providing a communication backbone for personal health devices to integrate with health record systems or cloud-based analytics via standardized data exchange.
• Product certification and compliance: Using the document as a reference for regulatory submissions or compliance verifications based on recognized international standards.
• Multi-function personal health devices: Enabling manufacturers to implement additional sensor modalities (e.g., adding respiration monitoring) alongside ECG under the same communication protocol.

Related Standards

ISO/IEEE FDIS 11073-10406 operates within a broad ecosystem of health informatics and device communication standards, including:

• ISO/IEEE 11073-20601: Health Informatics - Point-of-care medical device communication - Framework and overview.
• ISO/IEEE 11073-10101: Health Informatics - Nomenclature, providing controlled vocabulary for physiological data and device attributes.
• Other 11073-104xx standards: Device specializations for different personal health devices (e.g., blood pressure monitors, glucose meters).
• ISO/IEEE 11073 family: Comprehensive suite for medical device interoperability across multiple use cases, supporting safe and efficient data flow in digital health.

Adoption of ISO/IEEE FDIS 11073-10406 drives uniformity, interoperability, and regulatory harmonization across the fast-evolving personal health technology landscape, ensuring improved patient outcomes, data consistency, and integration flexibility.

FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10406
ISO/TC 215
Health Informatics — Device
Secretariat: ANSI
Interoperability —
Voting begins on:
2026-07-14
Part 10406:
Personal health device
Voting terminates on:
2026-12-01
communication, device
specialization, basic
electrocardiograph (ECG) (1- to
3-lead ECG)
This document has not been edited by the ISO Central Secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEEE FDIS 11073­10406:2026(en) © IEEE 2026

FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10406
ISO/TC 215
Health Informatics — Device
Secretariat: ANSI
Interoperability —
Voting begins on:
Part 10406:
Personal health device
Voting terminates on:
communication, device
specialization, basic
electrocardiograph (ECG) (1- to
3-lead ECG)
This document has not been edited by the ISO Central Secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPORTING D OCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
© IEEE 2026
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
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Website: www.ieee.org
Published in Switzerland Reference number
ISO/IEEE FDIS 11073­10406:2026(en)
© IEEE 2023
© IEEE 2026 – All rights reserved
ii
ISO/IEEE 11073-10406:2026(en)
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ISO/IEEE 11073-10406 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10406™-2023), in collaboration with the European
Committee for Standardization (CEN), in accordance with the Agreement on technical cooperation between
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between ISO and IEEE, by Technical Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO/IEEE 11073-10406:2012), which has been
technically revised.
The main changes are as follows:
— added support for Base-Offset-Time;
— defined new standard configuration 0x259;
© IEEE 2023 – All rights reserved
iii
ISO/IEEE 11073-10406:2026(en)
 updated Normative Reference, to refer to ISO/IEEE 11073-20601;
 updated version of this device specialization;
 updated the association details based on new version;
 updated the wording in 6.3 regarding the Observational;
 updated the examples in 8.4.2 and Annex E, to indicate the support of BaseOffsetTime;
 updated the qualifier in MDS and other objects to recommend BaseOffsetTime. Also updated the
description of the qualifiers in 6.5;
 added some text to 6.12 to further elaborate the DIM extensibility rule;
 corrected the use condition of GET MDS at E.4.1;
 updated the text in 8.5.2 regarding attribute-id-list, in order to be compliant with 20601-V4;
 added Clause 3.4 --- Compliance with other standards;
 removed the year in bibliography to represent the latest version;
 extended Table 1 to specify qualifier details for all possible configurations;
 updated the bit example in E.4.3, by inserting the Mds-Time-Info into MDS;
 made the ISO/IEEE 11073-10101 as normative reference;
 updated the wording at 1.3 and 4.1 regarding the precedence of nomenclature between 10101, 20601,
104xx and this standard;
 updated the usage of nomenclature-version. Tied it with the corresponding protocol-version.
A list of all parts in the ISO/IEEE 11073 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
© IEEE 2023 – All rights reserved
iv
ISO/IEEE 11073-10406:2026(en)
IEEE Std 11073-10406™-2023
(Revision of IEEE Std 11073-10406-2011)
Health Informatics—Device Interoperability
Part 10406: Personal Health Device
Communication—Device Specialization—
Basic Electrocardiograph (ECG)
(1- to 3-lead ECG)
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 15 February 2023
IEEE SA Standards Board
ISO/IEEE 11073-10406:2026(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, 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 is established in this standard. Appropriate portions of existing standards including
ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use
of specific term codes, formats, and behaviors in telehealth environments restricting optionality in
base frameworks in favor of interoperability is specified. A common core of communication
functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. 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).
Keywords: 1- to 3-lead ECG, basic electrocardiograph, ECG, IEEE 11073-10406™, medical
device communication, personal health devices
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Introduction
This introduction is not part of IEEE Std 11073-10406-2023, Health Informatics—Device Interoperability—
Part 10406: Personal Health Device Communication—Device Specialization—Basic Electrocardiograph (ECG) (1- to
3-lead ECG).
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 IEEE 11073-20601 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).
ISO/IEEE 11073-10406:2026(en)
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Chair
Malcolm Clarke, Vice-Chair
Raymond Krasinski, Secretary
Karsten Aalders Todd H. Cooper Shu Han
Charles R. Abbruscato Sandra Costanzo Nathaniel Hamming
Nabil Abujbara Douglas Coup Rickey L. Hampton
Maher Abuzaid Nigel Cox Sten Hanke
James Agnew Hans Crommenacker Aki Harma
Manfred Aigner Tomio Crosley Jordan Hartmann
Jorge Alberola Allen Curtis Kai Hassing
David Aparisi Jesús Daniel Trigo Avi Hauser
Lawrence Arne David Davenport Nathaniel Heintzman
Diego B. Arquillo Russell Davis Charles Henderson
Serafin Arroyo Sushil K. Deka Jun-Ho Her
Muhammad Asim Ciro de la Vega Timothy L. Hirou
Kit August Jim Dello Stritto Allen Hobbs
Doug Baird Kent Dicks Alex Holland
David Baker Hyoungho Do Arto Holopainen
Anindya Bakshi Fangjie Dong Kris Holtzclaw
Ananth Balasubramanian Jonathan Dougherty Robert Hoy
Sunlee Bang Xiaolian Duan Anne Huang
M. Jonathan Barkley Sourav Dutta Guiling Huang
Gilberto Barrón Jakob Ehrensvard Haofei Huang
David Bean Fredrik Einberg Zhiyong Huang
John Bell Javier Escayola Calvo David Hughes
Olivia Bellamou-Huet Mark Estes Robert D. Hughes
Rudy Belliardi Leonardo Estevez Jiyoung Huh
Daniel Bernstein Bosco T. Fernandes Hugh Hunter
George A. Bertos Christoph Fischer Philip O. Isaacson
Chris Biernacki Morten Flintrup Atsushi Ito
Ola Björsne Russell Foster Michael Jaffe
Thomas Blackadar Eric Freudenthal Praduman Jain
Thomas Bluethner Matthias Frohner Danny Jochelson
Douglas P. Bogia Ken Fuchs Akiyoshi Kabe
Xavier Boniface Jing Gao Steve Kahle
Shannon Boucousis Marcus Garbe Tomio Kamioka
Lyle G. Bullock, Jr. John Garguilo James J. Kang
Bernard Burg Liang Ge Kei Kariya
Chris Burns Rick Geimer Andy Kaschl
Jeremy Byford-Rew Igor Gejdos Junzo Kashihara
Satya Calloji Ferenc Gerbovics Ralph Kent
Carole C. Carey Alan Godfrey Laurie M. Kermes
Craig Carlson Nicolae Goga Sanjay R. Kharche
Santiago Carot-Nemesio Julian Goldman Ahmad Kheirandish
Seungchul Chae Raul Gonzalez Gomez Junhyung Kim
Yao Chen Chris Gough Minho Kim
Jing Cheng Channa Gowda Min-Joon Kim
Peggy Chien Charles M. Gropper Taekon Kim
David Chiu Amit Gupta Tetsuya Kimura
Jinyong Choi Jeff Guttmacher Michael J. Kirwan
Chia-Chin Chong Rasmus Haahr Alfred Kloos
Jinhan Chung Christian Habermann Edward Koch
John A. Cogan Michael Hagerty Jeongmee Koh
John T. Collins Jerry Hahn Jean-Marc Koller
Cory Condek Robert Hall John Koon
ISO/IEEE 11073-10406:2026(en)
Patty Krantz Bud Panjwani Rajagopalan Srinivasan
Alexander Kraus Carl Pantiskas Nicholas Steblay
Ramesh Krishna Harry P. Pappas Lars Steubesand
Geoffrey Kruse Hanna Park John (Ivo) Stivoric
Falko Kuester Jong-Tae Park Hermanni Suominen
Rafael Lajara Myungeun Park Lee Surprenant
Pierre Landau Phillip E. Pash Ravi Swami
Jaechul Lee TongBi Pei Ray Sweidan
JongMuk Lee Soren Petersen Haruyuyki Tatsumi
Kyong Ho Lee James Petisce Isabel Tejero
Rami Lee Peter Piction Chn Jonas Tirén
Sungkee Lee Michael Pliskin Janet Traub
Woojae Lee Varshney Prabodh Gary Tschautscher
Jing Li Jeff Price Masato Tsuchid
Qiong Li Harald Prinzhorn Ken Tubman
Xiangchen Li Lifei Qian Akib Uddin
Xiaoyu Li Harry Qiu Sunil Unadkat
Patrick Lichter Tanzilur Rahman Fabio Urbani
Jisoon Lim Lin Ran Philipp Urbauer
Wei-Jung Lo Phillip Raymond Laura Vanzago
Charles Lowe Terrie Reed Alpo Värri
Ling Luo Barry Reinhold Andrei Vasilateanu
Don Ludolph Brian Reinhold Dalimar Velez
Christian Luszick John G. Rhoads Martha Velezis
Bob MacWilliams Jeffrey S. Robbins Rudi Voon
Srikkanth Madhurbootheswaran Chris Roberts Isobel Walker
Miriam L. Makhlouf Moskowitz Robert David Wang
M. Sabarimalai Manikandan Stefan Robert Jerry P. Wang
Romain Marmot Scott M. Robertson Shiwei Wang
Sandra Martinez Timothy Robertson Yao Wang
Miguel Martínez de Sean Rocke Yi Wang
EsproncedaCámara David Rosales Steve Warren
Peter Mayhew Bill Saltzstein Fujio Watanabe
Jim McCain Giovanna Sannino Toru Watsuji
LászlóMeleg Jose A. Santos-Cadenas Kathleen Wible
Alexander Mense Stefan Sauermann Paul Williamson
Behnaz Minaei John Sawyer Jia-Rong Wu
Jinsei Miyazaki Alois Schloegl Will Wykeham
Madhu Mohan Paul S. Schluter Ariton Xhafa
Erik Moll Mark G. Schnell Ricky Yang
Darr Moore Richard A. Schrenker Melanie S. Yeung
Chris Morel Antonio Scorpiniti Qiang Yin
Carsten Mueglitz KwangSeok Seo Done-Sik Yoo
Soundharya Nagasubramanian Riccardo Serafin Zhi Yu
Alex Neefus Sid Shaw Jianchao Zeng
Trong-Nghia Nguyen-Dobinsky Frank Shen Jason Zhang
Michael E. Nidd Min Shih Zerui Zhang
Jim Niswander Mazen Shihabi Hongbo Zhao
Hiroaki Niwamoto Redmond Shouldice Shibai Zhao
Thomas Norgall Sternly K. Simon Yu Zhao
Yoshiteru Nozoe Marjorie Skubic Liang Zheng
Abraham Ofek Robert Smith Yuanhong Zhong
Brett Olive Ivan Soh Qing Zhou
BegonyaOtal Motoki Sone Miha Zoubek
Marco Paleari Emily Sopensky Szymon Zyskoter
ISO/IEEE 11073-10406:2026(en)
The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.
Robert Aiello Stuart Kerry Stefan Schlichting
Bjoern Andersen Raymond Krasinski Harry Solomon
Pradeep Balachandran H Moll Walter Struppler
Javier Espina Rajesh Murthy John Vergis
Kenneth Fuchs Bansi Patel Yu Yuan
Werner Hoelzl Esteban Pino Oren Yuen
Piotr Karocki Scott Robertson Daidi Zhong

When the IEEE SA Standards Board approved this standard on 15 February 2023, it had the following
membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary

Edward A. Addy Johnny Daozhuang Lin Mark Siira
Ramy Ahmed Fathy Kevin Lu Dorothy V. Stanley
J. Travis Griffith Daleep C. Mohla Lei Wang
Guido R. Hiertz Andrew Myles F. Keith Waters
Yousef Kimiagar Damir Novosel Karl Weber
Joseph L. Koepfinger* Annette D. Reilly Sha Wei
Thomas Koshy Robby Robson Philip B. Winston
John D. Kulick Jon Walter Rosdahl Daidi Zhong

ISO/IEEE 11073-10406:2026(en)
Contents
1. Overview .13
1.1 Scope .13
1.2 Purpose .13
1.3 Context .14
1.4 Word usage .14
2. Normative references .14
3. Definitions, acronyms, and abbreviations .15
3.1 Definitions .15
3.2 Acronyms and abbreviations .16
4. Introduction to ISO/IEEE 11073 personal health devices .16
4.1 General .16
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs .17
4.3 Compliance with other standards .17
5. Basic ECG (1- to 3-lead ECG) device concepts and modalities .18
5.1 General .18
5.2 ECG waveform .18
5.3 R-R interval .18
5.4 Heart rate .18
6. Basic ECG (1- to 3-lead ECG) domain information model .19
6.1 Overview .19
6.2 Class extensions .19
6.3 Object instance diagram .19
6.4 Types of configuration .20
6.5 Profiles .21
6.6 Medical device system object .23
6.7 Numeric objects .27
6.8 Real-time sample array objects .31
6.9 Enumeration objects .32
6.10 PM-store objects .35
6.11 Scanner objects .42
6.12 Class extension objects .44
6.13 Basic ECG (1- to 3-lead ECG) information model extensibility rules .45
7. Basic ECG (1- to 3-lead ECG) service model .45
7.1 General .45
7.2 Object access services.45
7.3 Object access event report services .48
8. Basic ECG (1- to 3-lead ECG) communication model .48
8.1 Overview .48
8.2 Communications characteristics .48
8.3 Association procedure .49
8.4 Configuring procedure .51
8.5 Operating procedure .52
8.6 Time synchronization .53
9. Test associations .53
ISO/IEEE 11073-10406:2026(en)
9.1 Behavior with standard configuration .53
9.2 Behavior with extended configurations .53
10. Conformance .53
10.1 Applicability .53
10.2 Conformance specification .54
10.3 Levels of conformance .54
10.4 Implementation conformance statements (ICSs) .54
Annex A (informative) Bibliography .59
Annex B (normative) Any additional ASN.1 definitions .60
B.1 Bit mappings for device, lead, and signal status .60
Annex C (normative) Allocation of identifiers .61
Annex D (informative) Message sequence examples .62
Annex E (informative) Protocol data unit examples .64
E.1 General .64
E.2 Association information exchange .64
E.3 Configuration information exchange .67
E.4 GET MDS attributes service .70
E.5 Data reporting.72
E.6 Disassociation .72
Annex F (informative) Revision history .74

ISO/IEEE 11073-10406:2026(en)
Health Informatics—Device Interoperability
Part 10406: Personal Health Device
Communication—Device Specialization—
Basic Electrocardiograph (ECG)
(1- to 3-lead ECG)
1. Overview
1.1 Scope
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 11073-20601 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).
1.2 Purpose
This standard addresses a need for an openly defined, independent standard for controlling information
exchange to and from personal health devices and managers (e.g., cell phones, personal computers,
personal health appliances, and set-top boxes). Interoperability is key to growing the potential market for
these devices and enabling people to be better informed participants in the management of their health.

Information on references can be found in Clause 2.
ISO/IEEE 11073-10406:2026(en)
IEEE Std 11073-10406-2023
Health Informatics—Device Interoperability—Part 10406: Personal Health Device Communication
Device Specialization—Basic Electrocardiograph (ECG) (1- to 3-lead ECG)
1.3 Context
See ISO/IEEE 11073-20601 for an overview of the environment within which this standard is written.
This standard defines the device specialization for the basic ECG (1- to 3-lead ECG), being a specific agent
type, and it provides a description of the device concepts, its capabilities, and its implementation according
to this standard.
This standard is based on ISO/IEEE 11073-20601, which in turn draws information from both ISO/IEEE
11073-10201:2004 [B6] and ISO/IEEE 11073-20101:2004 [B7]. The medical device encoding rules
(MDER) used within this standard are fully described in ISO/IEEE 11073-20601.
The object classes and attributes in this standard are identified by nomenclature codes. Each code consists of a
reference identifier (RefID) string and an integer code value. By using a
...