SIST EN ISO/IEEE 11073-10425:2025

SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST EN ISO 11073-10425:2019
Zdravstvena informatika - Interoperabilnost naprav - 10425. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Stalno spremljanje ravni
glukoze (ISO/IEEE 11073-10425:2024)
Health informatics - Device interoperability - Part 10425: Personal Health Device
Communication - Device Specialization- Continuous Glucose Monitor (CGM) (ISO/IEEE
11073-10425:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10425: Kommunikation von
Geräten für die persönliche Gesundheit - Gerätespezifikation - Kontinuierlicher Glukose-
Monitor (ISO/IEEE 11073-10425:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10425: Communication
entre dispositifs de santé personnels - Spécialisation des dispositifs - Glucomètre
continu (CGM) (ISO/IEEE 11073-10425:2024)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10425:2025
ICS:
11.040.55 Diagnostična oprema Diagnostic 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.

EN ISO/IEEE 11073-
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2025
ICS 35.240.80 Supersedes EN ISO 11073-10425:2019
English Version
Health informatics - Device interoperability - Part 10425:
Personal Health Device Communication - Device
Specialization- Continuous Glucose Monitor (CGM)
(ISO/IEEE 11073-10425:2024)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Interoperabilität von
- Partie 10425: Communication entre dispositifs de Geräten - Teil 10425: Kommunikation von Geräten für
santé personnels - Spécialisation des dispositifs - die persönliche Gesundheit - Gerätespezifikation -
Glucomètre continu (CGM) (ISO/IEEE 11073- Kontinuierlicher Glukose-Monitor (ISO/IEEE 11073-
10425:2024) 10425:2024)
This European Standard was approved by CEN on 30 September 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10425:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO/IEEE 11073-10425:2025) has been prepared by Technical Committee ISO/TC
215 "Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics”
the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2026, and conflicting national standards shall be
withdrawn at the latest by April 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11073-10425:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10425:2024 has been approved by CEN as EN ISO/IEEE 11073-
10425:2025 without any modification.

International
Standard
ISO/IEEE
11073-10425
Third edition
Health informatics — Device
2024-09
interoperability —
Part 10425:
Personal health device
communication — Device
specialization — Continuous
Glucose Monitor (CGM)
Informatique de santé — Interopérabilité des dispositifs —
Partie 10425: Communication entre dispositifs de santé personnels
— Spécialisation des dispositifs — Glucomètre continu (CGM)
Reference number
ISO/IEEE 11073-10425:2024(en) © IEEE 2024

ISO/IEEE 11073-10425:2024(en)
© IEEE 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10425:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
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through a consensus development process, approved by the American National Standards Institute, which
brings together volunteers representing varied viewpoints and interests to achieve the final product.
Volunteers are not necessarily members of the Institute and serve without compensation. While the IEEE
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ISO/IEEE 11073-10425 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10425) 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 third edition cancels and replaces the second edition (ISO/IEEE 11073-10425:2019), which has been
technically revised.
The main changes are as follows:
— updated Normative Reference to refer to IEEE Std 11073-20601-2019;
— updated version of this device specialization;
— updated the association details based on new version;
— updated the wording in 6.3 regarding the Observational;
— added some text to 6.12 to further elaborate the DIM extensibility rule;
— corrected the use condition of GET MDS at E.4.1;
© IEEE 2024 – All rights reserved
iii
ISO/IEEE 11073-10425:2024(en)
— updated the text in 8.5.2 regarding attribute-id-list, in order to be compliant with
20601-V4;
— added 4.3, Compliance with other standards;
— removed the year in bibliography to represent the latest version;
— 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;
— updated the examples in Annex E using protocol-version4.
A list of all parts in the ISO 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 2024 – All rights reserved
iv
ISO/IEEE 11073-10425:2024(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, a
normative definition of the communication between continuous glucose monitor (CGM) devices and
managers (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that
enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of
existing standards including ISO/IEEE 11073 terminology and 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
of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular
(typically 5 minute) basis through a sensor continuously attached to the person.

Keywords: continuous glucose monitor, IEEE 11073-10425™, medical device communication, personal health
devices
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ISO/IEEE 11073-10425:2024(en)
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ISO/IEEE 11073-10425:2024(en)
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ISO/IEEE 11073-10425:2024(en)
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viii
ISO/IEEE 11073-10425:2024(en)
Participants
At the time this IEEE standard was submitted to the IEEE SA Standards Board for approval, the Personal Health Devices
Working Group had the following membership:
Daidi Zhong, Chair
Malcolm Clarke, Vice-Chair
Raymond Krasinski, Secretary
Karsten Aalders Chia-Chin Chong Raul Gonzalez Gomez
Charles R. Abbruscato Jinhan Chung Chris Gough
Nabil Abujbara John A. Cogan Channa Gowda
Maher Abuzaid John T. Collins Charles M. Gropper
James Agnew Cory Condek Amit Gupta
Manfred Aigner Todd H. Cooper Jeff Guttmacher
Jorge Alberola Sandra Costanzo Rasmus Haahr
David Aparisi Douglas Coup Christian Habermann
Lawrence Arne Nigel Cox Michael Hagerty
Diego B. Arquillo Hans Crommenacker Jerry Hahn
Serafin Arroyo Tomio Crosley Robert Hall
Muhammad Asim Allen Curtis Shu Han
Kit August Jesús Daniel Trigo Nathaniel Hamming
Doug Baird David Davenport Rickey L. Hampton
David Baker Russell Davis Sten Hanke
Anindya Bakshi Sushil K. Deka Aki Harma
Ananth Balasubramanian Ciro de la Vega Jordan Hartmann
Sunlee Bang Jim Dello Stritto Kai Hassing
M. Jonathan Barkley Kent Dicks Avi Hauser
Gilberto Barrón Hyoungho Do Nathaniel Heintzman
David Bean Fangjie Dong Charles Henderson
John Bell Jonathan Dougherty Jun-Ho Her
Olivia Bellamou-Huet Xiaolian Duan Timothy L. Hirou
Rudy Belliardi Sourav Dutta Allen Hobbs
Daniel Bernstein Jakob Ehrensvard Alex Holland
George A. Bertos Fredrik Einberg Arto Holopainen
Chris Biernacki Javier Escayola Calvo Kris Holtzclaw
Ola Björsne Mark Estes Robert Hoy
Thomas Blackadar Leonardo Estevez Anne Huang
Thomas Bluethner Michael Faughn Guiling Huang
Douglas P. Bogia Bosco T. Fernandes Haofei Huang
Xavier Boniface Christoph Fischer Zhiyong Huang
Shannon Boucousis Morten Flintrup David Hughes
Lyle G. Bullock, Jr. Russell Foster Robert D. Hughes
Bernard Burg Eric Freudenthal Jiyoung Huh
Chris Burns Matthias Frohner Hugh Hunter
Jeremy Byford-Rew Kenneth Fuchs Philip O. Isaacson
Satya Calloji Jing Gao Atsushi Ito
Carole C. Carey Marcus Garbe Michael Jaffe
Craig Carlson John Garguilo Praduman Jain
Santiago Carot-Nemesio Liang Ge Zongbo Jiang
Seungchul Chae Rick Geimer Hu Jin
Yao Chen Igor Gejdos Danny Jochelson
Jing Cheng Ferenc Gerbovics Akiyoshi Kabe
Peggy Chien Alan Godfrey Steve Kahle
David Chiu Nicolae Goga Tomio Kamioka
Jinyong Choi Julian Goldman James J. Kang
© IEEE 2024 – All rights reserved
ix
ISO/IEEE 11073-10425:2024(en)
Kei Kariya Carsten Mueglitz Sid Shaw
Andy Kaschl Soundharya Nagasubramanian Frank Shen
Junzo Kashihara Alex Neefus Min Shih
Ralph Kent Trong-Nghia Nguyen-Dobinsky Mazen Shihabi
Laurie M. Kermes Michael E. Nidd Redmond Shouldice
Sanjay R. Kharche Jim Niswander Sternly K. Simon
Ahmad Kheirandish Hiroaki Niwamoto Marjorie Skubic
Junhyung Kim Thomas Norgall Robert Smith
Minho Kim Yoshiteru Nozoe Ivan Soh
Min-Joon Kim Abraham Ofek Motoki Sone
Taekon Kim Brett Olive Emily Sopensky
Tetsuya Kimura BegonyaOtal Rajagopalan Srinivasan
Michael J. Kirwan Marco Paleari Nicholas Steblay
Alfred Kloos Bud Panjwani Lars Steubesand
Edward Koch Carl Pantiskas John (Ivo) Stivoric
Jeongmee Koh Harry P. Pappas Hermanni Suominen
Jean-Marc Koller Hanna Park Lee Surprenant
John Koon Jong-Tae Park Ravi Swami
Patty Krantz Myungeun Park Ray Sweidan
Alexander Kraus Phillip E. Pash Na Tang
Ramesh Krishna TongBi Pei Haruyuyki Tatsumi
Geoffrey Kruse Soren Petersen Isabel Tejero
Falko Kuester James Petisce Tom Thompson
Rafael Lajara Peter Piction Jonas Tirén
Pierre Landau Michael Pliskin Janet Traub
Jaechul Lee Varshney Prabodh Gary Tschautscher
JongMuk Lee Jeff Price Masato Tsuchid
Kyong Ho Lee Harald Prinzhorn Ken Tubman
Rami Lee Lifei Qian Akib Uddin
Sungkee Lee Harry Qiu Sunil Unadkat
Woojae Lee Tanzilur Rahman Fabio Urbani
Jing Li Lin Ran Philipp Urbauer
Qiong Li Phillip Raymond Laura Vanzago
Xiangchen Li Terrie Reed Alpo Värri
Patrick Lichter Barry Reinhold Andrei Vasilateanu
Jisoon Lim Brian Reinhold Dalimar Velez
Wei-Jung Lo Melvin I. Reynolds Martha Velezis
Charles Lowe John G. Rhoads Rudi Voon
Don Ludolph Jeffrey S. Robbins Isobel Walker
Ling Luo Chris Roberts David Wang
Christian Luszick Moskowitz Robert Jerry P. Wang
Bob MacWilliams Stefan Robert Shiwei Wang
Srikkanth Madhurbootheswaran Scott M. Robertson Yao Wang
Miriam L. Makhlouf Timothy Robertson Yi Wang
M. Sabarimalai Manikandan Sean Rocke Steve Warren
Romain Marmot David Rosales Fujio Watanabe
Sandra Martinez Bill Saltzstein Toru Watsuji
Miguel Martínez de EsproncedaCámara Giovanna Sannino Kathleen Wible
Peter Mayhew Jose A. Santos-Cadenas
Jim McCain Stefan Sauermann Paul Williamson
LászlóMeleg John Sawyer Jia-Rong Wu
Alexander Mense Alois Schloegl Will Wykeham
Behnaz Minaei Paul S. Schluter Ariton Xhafa
Jinsei Miyazaki Mark G. Schnell Ricky Yang
Madhu Mohan Richard A. Schrenker Melanie S. Yeung
Erik Moll Antonio Scorpiniti Qiang Yin
Darr Moore KwangSeok Seo Done-Sik Yoo
Chris Morel Riccardo Serafin Zhi Yu
© IEEE 2024 – All rights reserved
x
ISO/IEEE 11073-10425:2024(en)
Jianchao Zeng Liang Zheng Miha Zoubek
Jason Zhang Daidi Zhong Szymon Zyskoter
Zerui Zhang Yuanhong Zhong
Shiwei Zhao Qing Zhou
The following members of the individual balloting committee voted on this standard. Balloters may have voted for approval,
disapproval, or abstention.
Robert Aiello Charles M. Gropper Bansi Patel
Cheryl Alexander Wang Werner Hoelzl Scott M. Robertson
Bjoern Andersen Piotr Karocki Stefan Schlichting
Pradeep Balachandran Stuart Kerry Walter Struppler
Malcolm Clarke Raymond Krasinski John Vergis
Javier Espina H. Moll Yu Yuan
Michael Faughn Rajesh Murthy Oren Yuen
Kenneth Fuchs Daidi Zhong
When the IEEE SA Standards Board approved this standard on 30 March 2023, it had the following membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Sara R. Biyabani Joseph S. Levy Paul Nikolich
Doug Edwards Howard Li Annette D. Reilly
Ramy Ahmed Fathy Johnny Daozhuang Lin Robby Robson
Guido R. Hiertz Gui Lin Lei Wang
Yousef Kimiagar Xiaohui Liu F. Keith Waters
Joseph L. Koepfinger* Kevin W. Lu Karl Weber
Thomas Koshy Daleep C. Mohla Philip B. Winston
John D. Kulick Andrew Myles Don Wright
*Member Emeritus
© IEEE 2024 – All rights reserved
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ISO/IEEE 11073-10425:2024(en)
Introduction
This introduction is not part of IEEE Std 11073-10425-2023, Health Informatics—Device Interoperability—Part 10425: Personal Health
Device Communication—Device Specialization—Continuous Glucose Monitor (CGM).
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This document uses
the optimized framework created in ISO/IEEE 11073-20601 and describes a specific, interoperable communication approach for
continuous glucose monitors (CGMs). These standards align with, and draw on, the existing clinically focused standards to
provide support for communication of data from clinical or personal health devices (PHDs).

Information on references can be found in Clause 2.
© IEEE 2024 – All rights reserved
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Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 Word usage . 1
1.4 Context . 1
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 2
3.1 Definitions . 2
3.2 Acronyms and abbreviations . 3
4. Introduction to ISO/IEEE 11073 personal health devices (PHDs) . 4
4.1 General . 4
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 4
4.3 Compliance with other standards . 5
5. Glucose monitoring concepts and modalities . 5
5.1 General . 5
5.2 Device types . 6
5.3 CGM agent-to-manager communication . 7
5.4 Collected data . 7
5.5 Stored data . 9
6. Continuous glucose monitor (CGM) domain information model (DIM) . 9
6.1 Overview . 9
6.2 Class extensions . 9
6.3 Object instance diagram . 9
6.4 Types of configuration . 11
6.5 Profiles . 11
6.6 MDS object. 11
6.7 Numeric objects . 14
6.8 Real-time sample array objects. 24
6.9 Enumeration objects . 24
6.10 PM-store objects . 27
6.11 Scanner objects . 31
6.12 Class extension objects . 31
6.13 CGM information model extensibility rules . 31
7. CGM service model . 32
7.1 General . 32
7.2 Object access services . 32
7.3 Object access event report services . 34
8. CGM communication model . 34
8.1 Overview . 34
8.2 Communication characteristics . 34
8.3 Association procedure . 35
8.4 Configuring procedure . 36
8.5 Operating procedure . 38
8.6 Time synchronization . 39
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ISO/IEEE 11073-10425:2024(en)
9. Test associations . 39
9.1 Behavior with standard configuration . 39
9.2 Behavior with extended configurations . 39
10. Conformance . 39
10.1 Applicability . 39
10.2 Conformance specification . 39
10.3 Levels of conformance. 40
Annex A (informative) Bibliography . 46
Annex B (normative) Any additional ASN.1 definitions . 47
Annex C (normative) Allocation of identifiers . 51
Annex D (informative) Message sequence examples . 56
Annex E (informative) Protocol data unit examples. 58
Annex F (informative) Revision history . 67

© IEEE 2024 – All rights reserved
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ISO/IEEE 11073-10425:2024(en)
Health Informatics—Device Interoperability
Part 10425:
Personal Health Device Communication—Device
Specialization—Continuous Glucose Monitor (CGM)
1. Overview
1.1 Scope
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM)
devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that
enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing
terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term
codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability.
This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the
measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to
the person.
1.2 Purpose
This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from
personal health devices (PHDs) and compute engines (e.g., cell phones, personal computers, personal health appliances, set top
boxes). Interoperability is the key to growing the potential market for these devices and to enabling people to be better informed
participants in the management of their health.
1.3 Word usage
The word shall indicates mandatory requirements strictly to be followed in order to conform to the standard and from which no
2, 3
deviation is permitted (shall equals is required to).
The word should indicates that among several possibilities one is recommended as particularly suitable, without mentioning or
excluding others; or that a certain course of action is preferred but not necessarily required (should equals is recommended that).
The word may is used to indicate a course of action permissible within the limits of the standard (may equals is permitted to
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