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 de santé personnels (agents) du type glucomètre continu (CGM) et des gestionnaires (par exemple, téléphones cellulaires, ordinateurs personnels, équipements de santé personnels et 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, notamment la terminologie, les modèles d'informations, les normes de profils d'applications et les normes de transport. Elle spécifie l'utilisation de codes, de formats et de comportements liés à des termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base favorisant l'interopérabilité. La présente norme définit un noyau commun de fonctionnalités de communication pour les dispositifs CGM. Dans ce contexte, CGM désigne la mesure régulière du niveau de glucose dans l'organisme (généralement toutes les 5 minutes) par le biais d'une sonde fixée en permanence sur 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

Status
Not Published
Public Enquiry End Date
29-Jun-2024
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
22-Apr-2024
Due Date
09-Sep-2024

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SLOVENSKI STANDARD
oSIST prEN ISO/IEEE 110736-10425:2024
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.

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oSIST prEN ISO/IEEE 110736-10425:2024

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oSIST prEN ISO/IEEE 110736-10425:2024
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.
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TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEEE FDIS 11073­10425:2024(en) © IEEE 2024

---------------------- Page: 3 ----------------------
oSIST prEN ISO/IEEE 110736-10425:2024
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
COPYRIGHT PROTECTED DOCUMENT
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
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Website: www.ieee.org
Published in Switzerland Reference number
ISO/IEEE FDIS 11073­10425:2024(en) © IEEE 2024

© IEEE 2024 – All rights reserved
ii

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oSIST prEN ISO/IEEE 110736-10425:2024
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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