SIST EN ISO/IEEE 11073-10472:2025

SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST EN ISO 11073-10472:2013
Zdravstvena informatika - Interoperabilnost naprav - 10472. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Naprava za nadzor jemanja
zdravil (ISO/IEEE 11073-10472:2024)
Health informatics - Device interoperability - Part 10472: Personal Health Device
Communication - Device Specialization - Medication Monitor (ISO/IEEE 11073-
10472:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10472: Kommunikation von
Geräten für die persönliche Gesundheit - Gerätespezifikation - Medikamentenmonitoring
(ISO/IEEE 11073-10472:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10472: Communication
entre dispositifs de santé personnels - Spécialisation des dispositifs - Moniteur de
surveillance de médication (ISO/IEEE 11073-10472:2024)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10472:2025
ICS:
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 11073-10472:2012
English Version
Health informatics - Device interoperability - Part 10472:
Personal Health Device Communication - Device
Specialization - Medication Monitor (ISO/IEEE 11073-
10472:2024)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Interoperabilität von
- Partie 10472: Communication entre dispositifs de Geräten - Teil 10472: Kommunikation von Geräten für
santé personnels - Spécialisation des dispositifs - die persönliche Gesundheit - Gerätespezifikation -
Moniteur de surveillance de médication (ISO/IEEE Medikamentenmonitoring (ISO/IEEE 11073-
11073-10472:2024) 10472:2024)
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 11073-10472:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO/IEEE 11073-10472:2025) 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 11073-10472:2012.
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 11073-10472:2024 has been approved by CEN as EN ISO/IEEE 11073-
10472:2025 without any modification.

International
Standard
ISO/IEEE
11073-10472
Second edition
Health informatics — Device
2024-09
interoperability —
Part 10472:
Personal health device
communication — Device
specialization — Medication monitor
Informatique de santé — Interopérabilité des dispositifs —
Partie 10472: Communication entre dispositifs de santé
personnels — Spécialisation des dispositifs — Moniteur de
surveillance de médication
Reference number
ISO/IEEE 11073-10472:2024(en) © IEEE 2024

ISO/IEEE 11073-10472:2024(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 11073-10472:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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ISO document should be noted (see www.iso.org/directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
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Volunteers are not necessarily members of the Institute and serve without compensation. While the IEEE
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ISO/IEEE 11073-10472 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10472) 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 11073-10472:2012), which has been
technically revised.
The main changes are as follows:
— added support for Base-Offset-Time;
— defined new standard configurations based on BaseOffsetTime;
— updated Clause 2 to include ISO/IEEE 11073-20601 and IEEE Std 11073-10101;
— updated version of this device specialization;
— updated the association details based on new version;
— updated the wording in 6.3 regarding the Observational;
© IEEE 2024 – All rights reserved
iii
ISO/IEEE 11073-10472:2024(en)
— 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 ISO/IEC
11073-20601;
— added subclause 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 wording at 1.3 and 4.1 regarding the precedence of nomenclature between
11073-10101, 11073-20601, 11073-104xx and this standard;
— updated the usage of nomenclature-version. Tied it with the corresponding protocol-version.
A list of all parts in the ISO 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 11073-10472:2024(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, a
normative definition of communication between personal telehealth medication monitor devices and
compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) is
established by this standard in a manner that enables plug-and-play interoperability. Appropriate portions of
existing standards including ISO/IEEE 11073 terminology, information models, application profile standards,
and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth
environments restricting optionality in base frameworks in favor of interoperability are specified. A common
core of communication functionality for personal telehealth medication monitor devices is defined in this
standard.
Keywords: device communication, IEEE 11073-10472™, medication monitor, personal health devices
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ISO/IEEE 11073-10472:2024(en)
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ISO/IEEE 11073-10472:2024(en)
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ISO/IEEE 11073-10472:2024(en)
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viii
ISO/IEEE 11073-10472:2024(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 Nigel Cox Kai Hassing
Charles R. Abbruscato Hans Crommenacker Avi Hauser
Nabil Abujbara Tomio Crosley Nathaniel Heintzman
Maher Abuzaid Allen Curtis Charles Henderson
James Agnew Jesús Daniel Trigo Jun-Ho Her
Manfred Aigner David Davenport Timothy L. Hirou
Jorge Alberola Russell Davis Allen Hobbs
David Aparisi Sushil K. Deka Alex Holland
Lawrence Arne Ciro de la Vega Arto Holopainen
Diego B. Arquillo Jim Dello Stritto Kris Holtzclaw
Serafin Arroyo Kent Dicks Robert Hoy
Muhammad Asim Hyoungho Do Anne Huang
Kit August Fangjie Dong Guiling Huang
Doug Baird Jonathan Dougherty Haofei Huang
David Baker Xiaolian Duan Zhiyong Huang
Anindya Bakshi Sourav Dutta David Hughes
Ananth Balasubramanian Jakob Ehrensvard Robert D. Hughes
Sunlee Bang Fredrik Einberg Jiyoung Huh
M. Jonathan Barkley Javier Escayola Calvo Hugh Hunter
Gilberto Barrón Mark Estes Philip O. Isaacson
David Bean Leonardo Estevez Atsushi Ito
John Bell Bosco T. Fernandes Michael Jaffe
Olivia Bellamou-Huet Christoph Fischer Praduman Jain
Rudy Belliardi Morten Flintrup Hu Jin
Daniel Bernstein Russell Foster Danny Jochelson
George A. Bertos Eric Freudenthal Akiyoshi Kabe
Chris Biernacki Matthias Frohner Steve Kahle
Ola Björsne Ken Fuchs Tomio Kamioka
Thomas Blackadar Jing Gao James J. Kang
Thomas Bluethner Marcus Garbe Kei Kariya
Douglas P. Bogia John Garguilo Andy Kaschl
Xavier Boniface Liang Ge Junzo Kashihara
Shannon Boucousis Rick Geimer Ralph Kent
Lyle G. Bullock, Jr. Igor Gejdos Laurie M. Kermes
Bernard Burg Ferenc Gerbovics Sanjay R. Kharche
Chris Burns Alan Godfrey Ahmad Kheirandish
Jeremy Byford-Rew Nicolae Goga Junhyung Kim
Satya Calloji Julian Goldman Minho Kim
Carole C. Carey Raul Gonzalez Gomez Min-Joon Kim
Craig Carlson Chris Gough Taekon Kim
Santiago Carot-Nemesio Channa Gowda Tetsuya Kimura
Seungchul Chae Charles M. Gropper Michael J. Kirwan
Yao Chen Amit Gupta Alfred Kloos
Jing Cheng Jeff Guttmacher Edward Koch
Peggy Chien Rasmus Haahr Jeongmee Koh
David Chiu Christian Habermann Jean-Marc Koller
Jinyong Choi Michael Hagerty John Koon
Chia-Chin Chong Jerry Hahn Patty Krantz
Jinhan Chung Robert Hall Alexander Kraus
John A. Cogan Shu Han Ramesh Krishna
John T. Collins Nathaniel Hamming Geoffrey Kruse
Cory Condek Rickey L. Hampton Falko Kuester
Todd H. Cooper Sten Hanke Rafael Lajara
Sandra Costanzo Aki Harma Pierre Landau
Douglas Coup Jordan Hartmann Jaechul Lee
© IEEE 2024 – All rights reserved
ix
ISO/IEEE 11073-10472:2024(en)
JongMuk Lee Phillip E. Pash Hermanni Suominen
Kyong Ho Lee TongBi Pei Lee Surprenant
Rami Lee Soren Petersen Ravi Swami
Sungkee Lee James Petisce Ray Sweidan
Woojae Lee Peter Piction Na Tang
Jing Li Michael Pliskin Haruyuyki Tatsumi
Qiong Li Varshney Prabodh Isabel Tejero
Xiangchen Li Jeff Price Chn Jonas Tirén
Xiaoyu Li Harald Prinzhorn Janet Traub
Patrick Lichter Lifei Qian Gary Tschautscher
Jisoon Lim Harry Qiu Masato Tsuchid
Wei-Jung Lo Tanzilur Rahman Ken Tubman
Charles Lowe Lin Ran Akib Uddin
Ling Luo Phillip Raymond Sunil Unadkat
Don Ludolph Terrie Reed Fabio Urbani
Christian Luszick Barry Reinhold Philipp Urbauer
Bob MacWilliams Brian Reinhold Laura Vanzago
Srikkanth Madhurbootheswaran John G. Rhoads Alpo Värri
Miriam L. Makhlouf Jeffrey S. Robbins Andrei Vasilateanu
M. Sabarimalai Manikandan Chris Roberts Dalimar Velez
Romain Marmot Moskowitz Robert Martha Velezis
Sandra Martinez Stefan Robert Rudi Voon
Miguel Martínez de EsproncedaCámara Scott M. Robertson Isobel Walker
Peter Mayhew Timothy Robertson David Wang
Jim McCain Sean Rocke Jerry P. Wang
LászlóMeleg David Rosales Shiwei Wang
Alexander Mense Bill Saltzstein Yao Wang
Behnaz Minaei Giovanna Sannino Yi Wang
Jinsei Miyazaki Jose A. Santos-Cadenas Steve Warren
Madhu Mohan Stefan Sauermann Fujio Watanabe
Erik Moll John Sawyer Toru Watsuji
Darr Moore Alois Schloegl Kathleen Wible
Chris Morel Paul S. Schluter Paul Williamson
Carsten Mueglitz Mark G. Schnell Jia-Rong Wu
Soundharya Nagasubramanian Richard A. Schrenker Will Wykeham
Alex Neefus Antonio Scorpiniti Ariton Xhafa
Trong-Nghia Nguyen-Dobinsky KwangSeok Seo Ricky Yang
Michael E. Nidd Riccardo Serafin Melanie S. Yeung
Jim Niswander Sid Shaw Qiang Yin
Hiroaki Niwamoto Frank Shen Done-Sik Yoo
Thomas Norgall Min Shih Zhi Yu
Yoshiteru Nozoe Mazen Shihabi Jianchao Zeng
Abraham Ofek Redmond Shouldice Jason Zhang
Sternly K. Simon Zerui Zhang
Brett Olive Marjorie Skubic Shibai Zhao
Begonya Otal Robert Smith Yu Zhao
Marco Paleari Ivan Soh Liang Zheng
Bud Panjwani Motoki Sone Yuanhong Zhong
Carl Pantiskas Emily Sopensky Qing Zhou
Harry P. Pappas Rajagopalan Srinivasan Miha Zoubek
Hanna Park Nicholas Steblay Szymon Zyskoter
Jong-Tae Park Lars Steubesand
Myungeun Park John (Ivo) Stivoric
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 Michael Faughn Stuart Kerry
Pradeep Balachandran Ken Fuchs Raymond Krasinski
Pin Chang Charles M. Gropper Erik Moll
Malcolm Clarke Werner Hoelzl Rajesh Murthy
Javier Espina Piotr Karocki Bansi Patel
© IEEE 2024 – All rights reserved
x
ISO/IEEE 11073-10472:2024(en)
Harry Solomon Yu Yuan
Scott M. Robertson Walter Struppler Oren Yuen
Stefan Schlichting John Vergis 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 Gui Lin Robby Robson
Guido R. Hiertz Johnny Daozhuang 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 11073-10472:2024(en)
Introduction
This introduction is not part of IEEE Std 11073-10472-2023, IEEE Standard for Health Informatics—Device Interoperability—Part 10472:
Personal Health Device Communication—Device Specialization—Medication Monitor.
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. Within the context
of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the
communication between medication monitoring devices 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 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 ambiguity in base frameworks in favor of interoperability. This standard
defines a common core of communication functionality for medication monitors. In this context, medication monitors are
defined as devices that have the ability to determine and communicate (to a manager) measures of a user’s adherence to a
medication regime.
© IEEE 2024 – All rights reserved
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ISO/IEEE 11073-10472:2024(en)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 Word usage . 1
1.4 Context . 2
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 . 3
4.1 General . 3
4.2 Introduction to IEEE 11073-20601 modeling constructs . 4
4.3 Compliance with other standards . 4
5. Medication monitor device concepts and modalities. 5
5.1 General . 5
5.2 Model usage examples . 6
5.3 Medication dispensed . 7
5.4 Status reporter . 7
5.5 User feedback . 8
5.6 Usage patterns . 8
6. Medication monitor domain information model . 9
6.1 Overview . 9
6.2 Class extensions . 9
6.3 Object instance diagram . 9
6.4 Types of configuration . 10
6.5 Medical device system object . 11
6.6 Numeric objects . 15
6.7 Real-time sample array objects. 25
6.8 Enumeration objects . 25
6.9 PM-store objects . 29
6.10 Scanner objects . 32
6.11 Class extension objects . 32
6.12 Medication monitor information model extensibility rules . 32
7. Medication monitor service model . 33
7.1 General . 33
7.2 Object access services . 33
7.3 Object access event report services . 34
8. Medication monitor communication model . 35
8.1 Overview . 35
8.2 Communications characteristics . 35
8.3 Association procedure . 35
8.4 Configuring procedure . 37
8.5 Operating procedure . 44
8.6 Time synchronization . 45
9. Test associations . 45
9.1 Behavior with standard configuration . 45
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ISO/IEEE 11073-10472:2024(en)
9.2 Behavior with extended configurations . 45
10. Conformance . 45
10.1 Applicability . 45
10.2 Conformance specification . 46
10.3 Levels of conformance . 46
10.4 Implementation conformance statements (ICSs) . 46
Annex A (informative) Bibliography . 52
Annex B (normative) Any additional ASN.1 definitions . 53
Annex C (normative) Allocation of identifiers . 54
Annex D (informative) Message sequence examples . 55
Annex E (informative) Protocol data unit examples . 57
E.1 General . 57
E.2 Association information exchange . 57
E.3 Configuration information exchange . 60
E.4 GET MDS attributes service . 62
E.5 Data reporting . 63
E.6 Disassociation . 64
Annex F (informative) Revisio
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