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EN ISO/IEEE 11073-10419:2023

(Main)

Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)

Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)

This standard establishes a normative definition of communication between personal telehealth insulin pump 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 functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2019)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10419: Spécialisation des dispositifs - Pompe à insuline (ISO/IEEE 11073-10419:2019)

La présente norme établit une définition normative de la communication entre des dispositifs (agents) pompes à insuline personnels de télésanté et des gestionnaires (par exemple, des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et 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 des dispositifs pompes à insuline personnels de télésanté.
Dans le contexte des dispositifs de santé personnels (PHD), une pompe à insuline est un dispositif médical utilisé pour administrer de l'insuline en traitement du diabète, également connu sous le nom de thérapie par perfusion sous-cutanée continue d'insuline (PSCI).
La présente norme fournit la modélisation des données conformément à l'ISO/IEEE 11073‑20601 et ne spécifie pas la méthode de mesurage.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del: Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2019)

Ta standard določa normativno opredelitev komunikacije med osebnimi telemedicinskimi napravami za črpanje inzulina in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play.
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 funkcionalnost skupnega jedra za osebne telemedicinske naprave za črpanje inzulina.
Inzulinska črpalka se v okviru osebnih medicinskih pripomočkov (PHD) uporablja za dovajanje inzulina pri zdravljenju sladkorne bolezni, poznanem tudi kot terapija s stalno subkutano infuzijo inzulina (CSII).
Ta standard podaja napotke za modeliranje podatkov v skladu s standardom ISO/IEEE 11073-20601 in ne določa merske metode.

General Information

Status
Published
Publication Date
29-Aug-2023
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Drafting Committee
CEN/TC 251 - Medical informatics
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
30-Aug-2023
Due Date
03-May-2025
Completion Date
30-Aug-2023
Ref Project
SIST EN ISO/IEEE 11073-10419:2023 - Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)

Relations

Replaces
EN ISO 11073-10419:2016 - Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
Effective Date
30-Aug-2023

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SLOVENSKI STANDARD
SIST EN ISO/IEEE 11073-10419:2023
01-november-2023
Nadomešča:
SIST EN ISO 11073-10419:2016
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del:
Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2019)
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2019)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation des dispositifs - Pompe à insuline (ISO/IEEE 11073-10419:2019)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10419:2023
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/IEEE 11073-10419:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO/IEEE 11073-10419:2023

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SIST EN ISO/IEEE 11073-10419:2023


EN ISO/IEEE 11073-
EUROPEAN STANDARD
10419
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2023
ICS 35.240.80 Supersedes EN ISO 11073-10419:2016
English Version

Health informatics - Personal health device
communication - Part 10419: Device specialization -
Insulin pump (ISO/IEEE 11073-10419:2019)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10419: für die persönliche Gesundheit - Teil 10419:
Spécialisation des dispositifs - Pompe à insuline Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-
(ISO/IEEE 11073-10419:2019) 10419:2019)
This European Standard was approved by CEN on 24 August 2023.

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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10419:2023 E
worldwide for CEN national Members.

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SIST EN ISO/IEEE 11073-10419:2023
EN ISO/IEEE 11073-10419:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO/IEEE 11073-10419:2023
EN ISO/IEEE 11073-10419:2023 (E)
European foreword
The text of ISO/IEEE 11073-10419:2019 has been prepared by Technical Committee ISO/TC 215
"Health informatics” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO/IEEE 11073-10419:2023 by 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 February 2024, and conflicting national standards
shall be withdrawn at the latest by February 2024.
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 11073-10419:2016.
Any feedback and questions on this document should be directed to the users’ national standards body.
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
followi
...

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