EN ISO 11073-10425:2019
(Main)Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019)
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019)
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 - 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)
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 - Komunikacija osebnih medicinskih naprav - 10425. del: Specialne naprave - Stalno spremljanje ravni glukoze (ISO/IEEE 11073-10425:2019)
Ta standard določa normativno opredelitev komunikacije med osebnimi medicinskimi pripomočki za stalno spremljanje ravni glukoze (agenti) in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi pripomočki, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost s takojšnjim učinkom (»vstavi in poženi«). Standard temelji na delu, doseženem v drugih standardih ISO/IEEE 11073, vključno z obstoječo terminologijo, informacijskimi profili, standardi za profile aplikacije in standardi za prevoz. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih, kjer v korist interoperabilnosti omejuje izbirnost osnovnih okvirov. Ta standard določa skupno jedro komunikacijske funkcionalnosti za naprave za stalno spremljanje ravni glukoze. V tem kontekstu se stalno spremljanje ravni glukoze navezuje na redno merjenje ravni glukoze v telesu (običajno na 5 minut) s senzorjem, ki je stalno pritrjen na osebo.
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SLOVENSKI STANDARD
SIST EN ISO 11073-10425:2019
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
SIST EN ISO 11073-10425:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11073-10425:2019
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SIST EN ISO 11073-10425:2019
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.
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SIST EN ISO 11073-10425:2019
EN ISO 11073-10425:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11073-10425:2019
EN ISO 11073-10425:2019 (E)
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,
...
SLOVENSKI STANDARD
oSIST prEN ISO 11073-10425:2018
01-november-2018
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10425. del:
Specialne naprave - Stalno spremljanje ravni glukoze (ISO/IEEE/FDIS 11073-
10425:2018)
Health informatics - Personal health device communication - Part 10425: Device
specialization - Continuous glucose monitor (CGM) (ISO/IEEE/FDIS 11073-10425:2018)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10425: Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO/IEEE/FDIS
11073-10425:2018)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10425: Spécialisation du dispositif - Glucomètre continu (CGM) (ISO/IEEE/FDIS 11073-
10425:2018)
Ta slovenski standard je istoveten z: prEN ISO 11073-10425
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 11073-10425:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11073-10425:2018
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oSIST prEN ISO 11073-10425:2018
FFIINANALL
IINNTTEERRNNAATTIIOONNAAL L ISO/IEEE/
DDRRAAFFTT
SSTTAANNDDAARRDD FDIS
11073-10425
215
Health informatics — Personal health
SeSeccrretariatetariat: ANSI: ANSI
device communication —
VVoting begins on:oting begins on:
20201188--09-03
Part 10425:
VVotioting ng tteerrmmiinnaatteess oonn::
Device specialization — Continuous
20201199--0101--21
glucose monitor (CGM)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10425: Spécialisation du dispositif — Glucomètre continu (CGM)
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
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oSIST prEN ISO 11073-10425:2018
ISO/IEEE FDIS 11073-10425:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© IEEE 2018
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Email: stds.ipr@ieee.org
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Published in Switzerland
ii © IEEE 2018 – All rights reserved
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oSIST prEN ISO 11073-10425:2018
ISO/IEEE FDIS 11073-10425:2018(E)
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
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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 documents should be noted (see www.iso.org/directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE‐SA) Standards Board. The IEEE develops its
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