prEN ISO/IEEE 11073-10425
(Main)Health informatics - Device interoperability - Part 10425: Personal Health Device Communication - Device Specialization- Continuous Glucose Monitor (CGM) (ISO/IEEE FDIS 11073-10425:2024)
Health informatics - Device interoperability - Part 10425: Personal Health Device Communication - Device Specialization- Continuous Glucose Monitor (CGM) (ISO/IEEE FDIS 11073-10425:2024)
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.
Medizinische Informatik - Interoperabilität von Geräten - Teil 10425: Kommunikation von Geräten für die persönliche Gesundheit - Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO/IEEE FDIS 11073-10425:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10425: Titre manque (ISO/IEEE FDIS 11073-10425:2024)
La présente norme établit une définition normative de la communication entre des dispositifs (agents) et des gestionnaires de glucomètres continus (CGM) personnels de santé (par exemple des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé, des boîtiers décodeurs) d’une manière qui permet une interopérabilité du type prêt à l’emploi. Elle s’appuie sur le travail réalisé dans d’autres normes ISO/IEEE 11073, y compris la terminologie, des modèles d’informations, des normes de profils d’applications et des normes de transport. Elle spécifie l’utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l’interopérabilité. La présente norme définit un noyau commun de fonctionnalités de communication des dispositifs CGM. Dans ce contexte, CGM désigne la mesure du niveau de glucose dans l’organisme relevé régulièrement (généralement toutes les 5 minutes) par le biais d’un capteur relié en permanence à la personne.
Zdravstvena informatika - Interoperabilnost naprav 10425. del: Komunikacija osebnih medicinskih naprav - Specialne naprave - Stalno spremljanje ravni glukoze (ISO/IEEE FDIS 11073-10425:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Zdravstvena informatika - Interoperabilnost naprav 10425. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Stalno spremljanje ravni
glukoze (ISO/IEEE FDIS 11073-10425:2024)
Health informatics - Device interoperability - Part 10425: Personal Health Device
Communication - Device Specialization- Continuous Glucose Monitor (CGM) (ISO/IEEE
FDIS 11073-10425:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10425: Kommunikation von
Geräten für die persönliche Gesundheit - Gerätespezifikation - Kontinuierlicher Glukose-
Monitor (ISO/IEEE FDIS 11073-10425:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10425: Titre manque
(ISO/IEEE FDIS 11073-10425:2024)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10425
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO/IEEE 110736- en,fr,de
10425:2024
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10425
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2024-04-11
Part 10425:
Personal Health Device
Voting terminates on:
2024-08-29
Communication — Device
Specialization- Continuous Glucose
Monitor (CGM)
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEEE FDIS 1107310425:2024(en) © IEEE 2024
FINAL DRAFT
ISO/IEEE FDIS 11073-10425:2024(en)
International
Standard
ISO/IEEE
FDIS
11073-10425
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10425:
Personal Health Device
Voting terminates on:
Communication — Device
Specialization- Continuous Glucose
Monitor (CGM)
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
© IEEE 2024
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
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Published in Switzerland Reference number
ISO/IEEE FDIS 1107310425:2024(en) © IEEE 2024
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10425:2024(en)
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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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