General Information

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
Publication Date
02-Apr-2028
Current Stage
4020 - Submission to enquiry - Enquiry
Start Date
16-Jul-2026
Completion Date
16-Jul-2026

Buy Documents

Draft

prEN ISO/IEEE 11073-10406:2026 - BARVE

English language (78 pages)
Preview
Preview
e-Library read for
1 day

Overview

prEN ISO/IEEE 11073-10406:2026 defines a framework for interoperability between personal basic electrocardiograph (ECG) devices and management systems such as smartphones, personal computers, personal health appliances, and set-top boxes. Developed within the context of the ISO/IEEE 11073 family of health informatics standards, this part focuses on communication protocols and device specialization for 1- to 3-lead basic ECGs used in telehealth and personal healthcare environments.

This standard leverages existing information models and terminologies from ISO/IEEE 11073 and IEEE 11073-20601 to ensure consistent data exchange and plug-and-play interoperability. By specifying structured codes, formats, and behaviors, it addresses the unique requirements of basic, wearable ECG devices while promoting interoperability and multi-functionality in personal health telemonitoring systems.

Key Topics

  • Interoperability of Personal ECG Devices
    Defines protocols for seamless communication between 1- to 3-lead ECG devices and managing systems, enabling easy integration and remote health monitoring.

  • Plug-and-Play Communication
    Establishes standards for automatic discovery, association, and operation of ECG devices within telehealth environments.

  • Support for Wearable Technology
    Focuses on non-diagnostic, monitoring-type ECGs commonly found in wearable and ambulatory health devices, limited to a maximum of three electrical leads.

  • Consistent Terminology and Information Models
    Adopts and updates core terminology, object models, and configurations from related standards for consistency and reliability in health data management.

  • Restricted Optionality for Interoperability
    Limits optional system configuration parameters, supporting a defined core set of communication features to maximize compatibility across devices and systems.

  • Multifunction Device Support
    Facilitates implementations where personal devices may combine ECG measurements with other physiological metrics, such as respiration rate, under a unified communication approach.

Applications

  • Remote Health Monitoring
    Enables real-time transmission of ECG data from patient-worn devices to healthcare providers or personal health records for continuous cardiac monitoring.

  • Telehealth and Mobile Health Solutions
    Supports integration of ECG data into telemedicine platforms, allowing for at-home cardiac assessment and prompt response to cardiac events.

  • Home-Based Health Appliances
    Standardizes data exchange for ECG functionality integrated into personal health appliances, enhancing self-management of cardiovascular health.

  • Interoperable Health IT Systems
    Ensures consistent and reliable communication between ECG devices and multiple types of management systems, supporting scalable and vendor-neutral digital health ecosystems.

Related Standards

  • ISO/IEEE 11073 Series
    The overarching framework for health informatics and interoperable medical device communication, of which Part 10406 is a key component.

  • ISO/IEEE 11073-20601
    Specifies foundational information models leveraged by the ECG device specialization for structured, standardized messaging.

  • ISO/IEEE 11073-10101
    Provides nomenclature for consistent coding of measurements and clinical concepts across interoperable health devices.

  • Relevant Device Specializations (104xx)
    Includes companion standards for device types such as pulse oximeters, blood pressure monitors, and other personal health measurement devices.


prEN ISO/IEEE 11073-10406:2026 is a critical standard for anyone developing, integrating, or implementing interoperable personal ECG solutions in telehealth and mobile health ecosystems. Its adoption facilitates secure, reliable, and standardized device communication, supporting remote patient monitoring and improved outcomes in digital health.

Relations

Effective Date
30-May-2026
Effective Date
27-May-2026

Buy Documents

Draft

prEN ISO/IEEE 11073-10406:2026 - BARVE

English language (78 pages)
Preview
Preview
e-Library read for
1 day

Get Certified

Connect with accredited certification bodies for this standard

BSI Group

BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.

UKAS United Kingdom Verified

NYCE

Mexican standards and certification body.

EMA Mexico Verified

Sponsored listings

Frequently Asked Questions

prEN ISO/IEEE 11073-10406 is a draft published by the European Committee for Standardization (CEN). Its full title is "Health Informatics - Device Interoperability - Part 10406: Personal health device communication, device specialization, basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE FDIS 11073-10406:2026)". This standard covers: 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).

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).

prEN ISO/IEEE 11073-10406 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.

prEN ISO/IEEE 11073-10406 has the following relationships with other standards: It is inter standard links to ISO/IEEE FDIS 11073-10406, EN ISO 11073-10406:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

prEN ISO/IEEE 11073-10406 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-september-2026
Zdravstvena informatika - Interoperabilnost naprav - 10406. del: Komunikacija
osebnih medicinskih naprav, specialne naprave, osnovni elektrokardiograf (EKG)
(od 1- do 3-odvodni EKG) (ISO/IEEE FDIS 11073-10406:2026)
Health Informatics - Device Interoperability - Part 10406: Personal health device
communication, device specialization, basic electrocardiograph (ECG) (1- to 3-lead
ECG) (ISO/IEEE FDIS 11073-10406:2026)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10406: Gerätespezifikation - Basiselektrokardiogramm (EKG) (EKG mit 1 bis 3
Ableitungen) (ISO/IEEE FDIS 11073-10406:2026)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10406: Spécialisation des dispositifs - Électrocardiographe de base (ECG) (ECG 1 à 3)
(ISO/IEEE FDIS 11073-10406:2026)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10406
ICS:
11.040.50 Radiografska oprema Radiographic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
ISO/IEEE FDIS 11073-10406:2026(en)
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.
TO BECOME STAND ARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: stds.ipr@ieee.org
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)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards ISO
(the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has
been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted (see www.iso.org/directives).
IEEE Standards documents are developed within IEEE Societies and subcommittees of IEEE Standards
Association (IEEE SA) Board of Governors. IEEE develops its standards through an accredited consensus
development process, which brings together volunteers representing varied viewpoints and interests to
achieve the final product. IEEE standards are documents developed by volunteers with scientific, academic,
and industry-based expertise in technical working groups. Volunteers are not necessarily members of IEEE or
IEEE SA and participate without compensation from IEEE. While IEEE administers the process
and establishes rules to promote fairness in the consensus development process, IEEE does not independently
evaluate, test, or verify the accuracy of any of the information or the soundness of any judgments contained in
its standards.
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had received notice of (a) patent(s) which
may be required to implement this document. However, implementers are cautioned that this may
not represent the latest information, which may be obtained from the patent database available
at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
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
ISO and CEN (Vienna Agreement), and drafted in accordance with its editorial rules. It was adopted, under the
“fast-track procedure” defined in the Partner Standards Development Organization cooperation agreement
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
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
All rights reserved. Published 19 October 2023. Printed in the United States of America.
IEEE is a registered trademarks in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics Engineers,
Incorporated.
PDF: 979-8-8557-0178-4 STD26518
Print: 979-8-8557-0179-1 STDPD26518
IEEE prohibits discrimination, harassment and bullying. For more information, visit https://www.ieee.org/about/corporate/governance/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
ISO/IEEE 11073-10406:2026(en)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE Standards documents are made available for use subject to important notices and legal disclaimers.
These notices and disclaimers, or a reference to this page (https://standards.ieee.org/ipr/disclaimers.html),
appear in all standards and may be found under the heading “Important Notices and Disclaimers
Concerning IEEE Standards Documents.”
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents are developed within IEEE Societies and subcommittees of IEEE Standards
Association (IEEE SA) Board of Governors. IEEE develops its standards through an accredited consensus
development process, which brings together volunteers representing varied viewpoints and interests to
achieve the final product. IEEE Standards are documents developed by volunteers with scientific, academic,
and industry-based expertise in technical working groups. Volunteers are not necessarily members of IEEE
or IEEE SA and participate without compensation from IEEE. While IEEE administers the process and
establishes rules to promote fairness in the consensus development process, IEEE does not independently
evaluate, test, or verify the accuracy of any of the information or the soundness of any judgments contained
in its standards.
IEEE makes no warranties or representations concerning its standards, and expressly disclaims all
warranties, express or implied, concerning this standard, including but not limited to the warranties of
merchantability, fitness for a particular purpose and non-infringement. In addition, IEEE does not warrant
or represent that the use of the material contained in its standards is free from patent infringement. IEEE
standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE Standard does not imply that there
are no other ways to produce, test, measure, purchase, market, or provide other goods and services related
to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved
and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other
services for, or on behalf of, any person or entity, nor is IEEE undertaking to perform any duty owed by
any other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon
his or her own independent judgment in the exercise of reasonable care in any given circumstances or, as
appropriate, seek the advice of a competent professional in determining the appropriateness of a given
IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO: THE
NEED TO PROCURE SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
that an IEEE standard is translated, only the English version published by IEEE is the approved IEEE
standard.
ISO/IEEE 11073-10406:2026(en)
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE SA Standards Board
Operations Manual shall not be considered or inferred to be the official position of IEEE or any of its
committees and shall not be considered to be, nor be relied upon as, a formal position of IEEE. At lectures,
symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall
make it clear that the presenter’s views should be considered the personal views of that individual rather
than the formal position of IEEE, IEEE SA, the Standards Committee, or the Working Group. Statements
made by volunteers may not represent the formal position of their employer(s) or affiliation(s).
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of
membership affiliation with IEEE or IEEE SA. However, IEEE does not provide interpretations,
consulting information, or advice pertaining to IEEE Standards documents.
Suggestions for changes in documents should be in the form of a proposed change of text, together with
appropriate supporting comments. Since IEEE standards represent a consensus of concerned interests, it is
important that any responses to comments and questions also receive the concurrence of a balance of
interests. For this reason, IEEE and the members of its Societies and subcommittees of the IEEE SA Board
of Governors are not able to provide an instant response to comments, or questions except in those cases
where the matter has previously been addressed. For the same reason, IEEE does not respond to
interpretation requests. Any person who would like to participate in evaluating comments or in revisions to
an IEEE standard is welcome to join the relevant IEEE working group. You can indicate interest in a
working group using the Interests tab in the Manage Profile & Interests area of the IEEE SA myProject
system. An IEEE Account is needed to access the application.
Comments on standards should be submitted using the Contact Us form.
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not constitute compliance to any applicable
regulatory requirements. Implementers of the standard are responsible for observing or referring to the
applicable regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action
that is not in compliance with applicable laws, and these documents may not be construed as doing so.
Data privacy
Users of IEEE Standards documents should evaluate the standards for considerations of data privacy and
data ownership in the context of assessing and using the standards in compliance with applicable laws and
regulations.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under US and international copyright laws.
They are made available by IEEE and are adopted for a wide variety of both public and private uses. These
include both use, by reference, in laws and regulations, and use in private self-regulation, standardization,
and the promotion of engineering practices and methods. By making these documents available for use and
Available at: https://development.standards.ieee.org/myproject-web/public/view.html#landing.
Available at: https://standards.ieee.org/content/ieee-standards/en/about/contact/index.html.
ISO/IEEE 11073-10406:2026(en)
adoption by public authorities and private users, neither IEEE nor its licensors waive any rights in
copyright to the documents.
Photocopies
Subject to payment of the appropriate licensing fees, IEEE will grant users a limited, non-exclusive license
to photocopy portions of any individual standard for company or organizational internal use or individual,
non-commercial use only. To arrange for payment of licensing fees, please contact Copyright Clearance
Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA; +1 978 750 8400;
https://www.copyright.com/. Permission to photocopy portions of any individual standard for educational
classroom use can also be obtained through the Copyright Clearance Center.
Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect.
Every IEEE standard is subjected to review at least every 10 years. When a document is more than 10 years
old and has not undergone a revision process, it is reasonable to conclude that its contents, although still of
some value, do not wholly reflect the present state of the art. Users are cautioned to check to determine that
they have the latest edition of any IEEE standard.
In order to determine whether a given document is the current edition and whether it has been amended
through the issuance of amendments, corrigenda, or errata, visit IEEE Xplore or contact IEEE. For more
information about the IEEE SA or IEEE’s standards development process, visit the IEEE SA Website.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE SA Website. Search for standard
number and year of approval to access the web page of the published standard. Errata links are located
under the Additional Resources Details section. Errata are also available in IEEE Xplore. Users are
encouraged to periodically check for errata.
Patents
IEEE Standards are developed in compliance with the IEEE SA Patent Policy.
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE SA Website at https://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Available at: https://ieeexplore.ieee.org/browse/standards/collection/ieee.
Available at: https://standards.ieee.org/standard/index.html.
Available at: https://standards.ieee.org/about/sasb/patcom/materials.html.
ISO/IEEE 11073-10406:2026(en)
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely
their own responsibility. Further information may be obtained from the IEEE Standards Association.
IMPORTANT NOTICE
IEEE Standards do not guarantee or ensure safety, security, health, or environmental protection, or ensure
against interference with or from other devices or networks. IEEE Standards development activities
consider research and information presented to the standards development group in developing any safety
recommendations. Other information about safety practices, changes in technology or technology
implementation, or impact by peripheral systems also may be pertinent to safety considerations during
implementation of the standard. Implementers and users of IEEE Standards documents are responsible for
determining and complying with all appropriate safety, security, environmental, health, and interference
protection practices and all applicable laws and regulations.
ISO/IEEE 11073-10406:2026(en)
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
wea
...