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
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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
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,
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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 the IEEE Societies and the Standards Coordinating
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through a consensus development process, approved by the American National Standards Institute, which
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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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v
ISO/IEEE 11073-10472:2024(en)
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