Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)

The scope of this standard is to establish 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, 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 the ISO/IEEE 11073-20601 standard, and does not specify the measurement method.

Medizinsche Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2016)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10419: Spécialisation du dispositif - Pompe à insuline (ISO/IEEE 11073-10419:2016)

Le domaine d'application de l'ISO/IEEE 11073-10419:2016 consiste à établir 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, 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).
ISO/IEEE 11073-10419:2016 fournit la modélisation des données conformément à la norme 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 11073-10419:2016, popravljena različica 2018-03)

Področje uporabe tega standarda vzpostavlja 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 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
Withdrawn
Publication Date
06-Nov-2016
Withdrawal Date
25-Sep-2023
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
22-Sep-2023
Due Date
15-Oct-2023
Completion Date
26-Sep-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11073-10419:2016
01-december-2016
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del:
Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2016, popravljena
različica 2018-03)
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
Medizinsche Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2016)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation du dispositif - Pompe à insuline (ISO/IEEE 11073-10419:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10419:2016
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10419:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11073-10419:2016

---------------------- Page: 2 ----------------------
SIST EN ISO 11073-10419:2016


EN ISO 11073-10419
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version

Health informatics - Personal health device
communication - Part 10419: Device specialization -
Insulin pump (ISO/IEEE 11073-10419:2016, Corrected
version 2018-03)
Informatique de santé - Communication entre Medizinsche Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10419: für die persönliche Gesundheit - Teil 10419:
Spécialisation du dispositif - Pompe à insuline Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-
(ISO/IEEE 11073-10419:2016) 10419:2016)
This European Standard was approved by CEN on 28 February 2016.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 21 November 2018.

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 NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10419:2016 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 11073-10419:2016
EN ISO 11073-10419:2016 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 11073-10419:2016
EN ISO 11073-10419:2016 (E)
European foreword
This document (EN ISO 11073-10419:2016) 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 December 2016, and conflicting national standards
shall be withdrawn at the latest by December 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Luxembour
...

SLOVENSKI STANDARD
SIST EN ISO 11073-10419:2016
01-december-2016
=GUDYVWYHQDLQIRUPDWLND.RPXQLNDFLMDRVHEQLKPHGLFLQVNLKQDSUDYGHO
6SHFLDOQHQDSUDYH,Q]XOLQVNDþUSDOND ,62,(((
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE 11073-10419:2016)
Medizinsche Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2016)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation du dispositif - Pompe à insuline (ISO/IEEE 11073-10419:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10419:2016
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10419:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11073-10419:2016

---------------------- Page: 2 ----------------------

SIST EN ISO 11073-10419:2016


EN ISO 11073-10419
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version

Health informatics - Personal health device
communication - Part 10419: Device specialization -
Insulin pump (ISO/IEEE 11073-10419:2016)
Informatique de santé - Communication entre Medizinsche Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10419: für die persönliche Gesundheit - Teil 10419:
Spécialisation du dispositif - Pompe à insuline Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-
(ISO/IEEE 11073-10419:2016) 10419:2016)
This European Standard was approved by CEN on 28 February 2016.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10419:2016 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 11073-10419:2016
EN ISO 11073-10419:2016 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 11073-10419:2016
EN ISO 11073-10419:2016 (E)
European foreword
This document (EN ISO 11073-10419:2016) 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 December 2016, and conflicting national standards
shall be withdrawn at the latest by December 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10419:2016 has been approve
...

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