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
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© 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
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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The procedures used to develop this document and those intended for its further maintenance are described
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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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