oSIST prEN ISO/IEEE 11073-10406:2026

• 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
• Public Enquiry End Date: 09-Nov-2026
• ICS: 11.040.50 - Radiographic equipment
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 22-Jul-2026
• Due Date: 09-Dec-2026
• Completion Date: 20-Aug-2026
• Ref Project: prEN ISO/IEEE 11073-10406 - 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)

• Revises: SIST EN ISO 11073-10406:2013 - Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
• Effective Date: 27-May-2026

oSIST prEN ISO/IEEE 11073-10406:2026 is a CEN draft standard in the ISO/IEEE 11073 device interoperability family. It specifies how personal basic electrocardiograph (ECG) devices with 1- to 3-lead ECG communicate with managers such as cell phones, personal computers, personal health appliances, and set-top boxes so they can interoperate in telehealth use.

What does oSIST prEN ISO/IEEE 11073-10406:2026 specify?

oSIST prEN ISO/IEEE 11073-10406:2026 defines a device specialization for personal basic ECG communication. It sets the communication model, data model, service model, and conformance rules for a basic ECG agent and a manager.

The standard narrows optional behavior to improve interoperability. It distinguishes monitoring ECG devices from diagnostic ECG equipment, limits support to three leads, and focuses on waveform acquisition, recording, R-R interval, and heart rate rather than cardiac diagnosis.

Annex	What it covers
Annex A	Bibliography
Annex B	Additional ASN.1 definitions, including bit mappings for device, lead, and signal status
Annex C	Allocation of identifiers and nomenclature codes
Annex D	Message sequence examples
Annex E	Protocol data unit examples
Annex F	Revision history

The document is organized into clauses 1 to 10. These cover scope and purpose, references, definitions, the general PHD context, device concepts, the domain information model, service model, communication model, test associations, and conformance.

What are the key requirements of oSIST prEN ISO/IEEE 11073-10406:2026?

oSIST prEN ISO/IEEE 11073-10406:2026 builds on ISO/IEEE 11073-20601 and then fixes the choices needed for a basic ECG implementation. In practice, this is the part developers use to decide which objects to support, which services to implement, and how a manager should interact with the agent.

Device model and object structure

Clause 6 defines the basic ECG domain information model. The model includes the medical device system (MDS) object, numeric objects, real-time sample array (RT-SA) objects, enumeration objects, PM-store objects, and scanner objects. For implementers, that means the ECG device is not described as a single data stream but as a set of managed objects with defined attributes, methods, and events.

The standard uses attribute qualifiers such as mandatory, conditional, recommended, not recommended, and optional. It also distinguishes static, dynamic, and observational attributes. That matters because it tells an implementer what must be present, what may change during an association, and what data must be available before a report can be interpreted.

Profiles, extensibility, and identifiers

Clause 6.5 defines a simple ECG profile and a heart rate profile. Clause 6.13 allows the model to be extended with ISO/IEEE 11073-20601 elements and vendor-specific elements, while keeping those extensions aligned with the standard structure. For a manufacturer, this is the rule set for adding non-standard features without breaking interoperability.

The standard also assigns nomenclature codes in Annex C and reserves private numbering space for vendor-specific objects and attributes. In practice, a manager can identify the meaning of object classes and data items from their codes, which is what allows two different products to exchange ECG data consistently.

Services and data exchange

Clause 7 defines the service model. The basic ECG agent supports GET, SET, event report, and action services. GET is used to read MDS and PM-store data, SET is limited to the operational-state attributes of the scanner objects, event reports carry configuration and measurement data, and action services cover time setting and PM-store operations.

Clause 7.3 sets the reporting behavior. MDS event reports are used in confirmed mode, scanner reports may be confirmed or unconfirmed, and measurement data must be supportable in agent-initiated mode or persistently stored metric mode. The manager must support both single-person and multiple-person report styles, while the agent may support one or both. That matters for telehealth systems that may handle one user at a time or data from several people.

Communication limits and time handling

Clause 8 defines the communication model and the APDU size limits the agent has to handle. The permitted sizes depend on whether the agent supports persistent metric storage and on the chosen profile. If an implementation also supports other device specializations, the limits are combined according to the standard rules. Practically, this controls how much ECG data can be sent in one exchange and when a device must split data into multiple reports.

Clause 8.6 allows time synchronization between agent and manager, but the synchronization mechanism itself is outside the scope of the document. If time sync is used, the device must report that fact in the Mds-Time-Info attribute. That helps keep ECG observations aligned with the recording time used by the manager.

Test and conformance behavior

Clause 9 defines test associations for the standard configuration. In test mode, normal physiological processing is suspended and the device sends a simulated heart rate value that is clearly outside normal use. This gives manufacturers a controlled way to demonstrate behavior without mixing test data with real patient data.

Clause 10 requires conformance to be declared through implementation conformance statements (ICSs). The document defines base conformance and extended nomenclature conformance. For a buyer or integrator, the ICS is the practical checklist for seeing which objects, services, and extensions a product really supports.

What terms does oSIST prEN ISO/IEEE 11073-10406:2026 define?

• agent - The device role that collects personal health data and sends it to a manager.
• manager - The device role that receives data from one or more agents.
• Medical device system (MDS) - The top-level managed object that represents the device and exposes its key attributes and events.
• Domain information model (DIM) - The object model used to describe the device, its data, and its behavior.
• real-time sample array (RT-SA) - The object type used for streaming waveform data such as ECG traces.
• PM-store - The persistent storage model used to keep measurements for later transfer.
• Implementation conformance statements (ICSs) - The formal declarations a vendor uses to state which parts of the standard an implementation supports.

Who uses oSIST prEN ISO/IEEE 11073-10406:2026?

oSIST prEN ISO/IEEE 11073-10406:2026 is used by manufacturers of personal ECG devices, telehealth device developers, and software teams that build managers on phones, PCs, home health appliances, or set-top boxes. It is also relevant to quality and regulatory teams that need to document conformance, and to test laboratories that verify association, configuration, reporting, and test-association behavior.

Healthcare IT integrators use it when connecting ECG devices into broader personal health device systems. Buyers and procurement teams use it to compare whether a product supports the ECG communication features they need, especially for interoperable remote monitoring.

What changed in oSIST prEN ISO/IEEE 11073-10406:2026 from the previous edition?

This second edition cancels and replaces ISO/IEEE 11073-10406:2012. The main changes stated in the document are:

• support for Base-Offset-Time was added
• a new standard configuration 0x259 was defined
• the normative reference to ISO/IEEE 11073-20601 was updated
• the device specialization version and association details were updated
• wording was revised around observational data and qualifier handling
• examples in Clause 8 and Annex E were updated for BaseOffsetTime
• BaseOffsetTime was recommended in MDS and other objects
• the DIM extensibility rule was expanded
• GET MDS use conditions were corrected
• the attribute-id-list text was aligned with 20601-V4
• Clause 3.4 on compliance with other standards was added
• ISO/IEEE 11073-10101 was made a normative reference
• nomenclature precedence and nomenclature-version usage were updated

Which standards are used with oSIST prEN ISO/IEEE 11073-10406:2026?

Standard	What it contributes
ISO/IEEE 11073-10101	The nomenclature used for object, attribute, and term codes
ISO/IEEE 11073-20601	The base application profile, information models, encoding, and communication framework

Clause 4.3 also points implementers to common safety, software, and risk-management standards used alongside medical device work, including IEC 60601-1, IEC 60601-2 series, IEC 62304, ISO 14971, and IEC 80001-1.

What does the oSIST prEN ISO/IEEE 11073-10406:2026 document contain?

The document includes the ECG device concepts, the information model, the service model, the communication model, and the conformance rules needed to implement a basic ECG agent and manager. Figure 1 explains the ECG signal context, and Figure 2 shows the object structure of the domain information model.

Table 24 summarizes the supported object access services, including GET, SET, event report, and action interactions. Annex B provides ASN.1 definitions needed by the standard, Annex C lists identifier allocation, and Annexes D and E give message sequence and PDU examples for association, configuration, GET MDS attributes, data reporting, and disassociation. These examples are useful for design reviews, software implementation, and interoperability testing.

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
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ISO/IEEE FDIS 11073­10406:2026(en)
© IEEE 2023
© IEEE 2026 – All rights reserved
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ISO/IEEE 11073-10406:2026(en)
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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
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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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ISO/IEEE 11073-10406:2026(en)
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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
...