EN ISO 11073-10425:2019

SLOVENSKI STANDARD
01-junij-2019
Nadomešča:
SIST EN ISO 11073-10425:2017
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10425. del:
Specialne naprave - Stalno spremljanje ravni glukoze (ISO/IEEE 11073-10425:2019)
Health informatics - Personal health device communication - Part 10425: Device
specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10425: Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO/IEEE 11073-
10425:2019)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10425: Spécialisation du dispositif - Glucomètre continu (CGM) (ISO/IEEE 11073-
10425:2019)
Ta slovenski standard je istoveten z: EN ISO 11073-10425:2019
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 11073-10425
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11073-10425:2016
English Version
Health informatics - Personal health device
communication - Part 10425: Device specialization -
Continuous glucose monitor (CGM) (ISO/IEEE 11073-
10425:2019)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10425: für die persönliche Gesundheit - Teil 10425:
Spécialisation du dispositif - Glucomètre continu Gerätespezifikation - Kontinuierlicher Glukose-Monitor
(CGM) (ISO/IEEE 11073-10425:2019) (ISO/IEEE 11073-10425:2019)
This European Standard was approved by CEN on 22 February 2019.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10425:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11073-10425:2019) 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 October 2019, and conflicting national standards shall
be withdrawn at the latest by October 2019.
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 11073-10425:2016.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10425:2019 has been approved by CEN as EN ISO 11073-10425:2019
without any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10425
Second edition
2019-03
Health informatics — Personal health
device communication —
Part 10425:
Device specialization — Continuous
glucose monitor (CGM)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10425: Spécialisation du dispositif — Glucomètre continu (CGM)
Reference number
ISO/IEEE 11073-10425:2019(E)
©
IEEE 2018
ISO/IEEE 11073-10425:2019(E)
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ISO/IEEE 11073-10425:2019(E)
Foreword
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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 11073‐10425‐2017) 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 11073‐10425:2016), which has
been technically revised.
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 2018– All rights reserved iii

ISO/IEEE 11073-10425:2019(E)
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 11073-10425:2019(E)
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