EN ISO/IEEE 11073-10419:2023

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO/IEEE 11073-
EUROPEAN STANDARD
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.

Contents Page
European foreword . 3

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
following countries are bound to implement this European Standard: 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 the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10419:2019 has been approved by CEN as EN ISO/IEEE 11073-
10419:2023 without any modification.

ISO/IEEE
INTERNATIONAL
11073-10419
STANDARD
Second edition
2019-03
Health informatics — Personal health
device communication —
Part 10419:
Device specialization — Insulin pump
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10419: Spécialisation des dispositifs — Pompe à insuline
Reference number
ISO/IEEE 11073-10419:2019(E)
©
IEEE 2018
ISO/IEEE 11073-10419:2019(E)
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ISO/IEEE 11073-10419:2019(E)
Foreword
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ISO/IEEE 11073-10419 was prepared by the IEEE 11073 Standards Committee of the IEEE
Engineering in Medicine and Biology Society (as IEEE Std 11073-10419-2017) 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 second edition cancels and replaces the first edition (ISO 11073-10419:2016), which has been
technically revised.
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 2018 – All rights reserved iii

ISO/IEEE 11073-10419:2019(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication between personal telehealth insulin
pump devices and compute engines (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, information models, 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. The standard defines a
common core of communication functionality for personal telehealth insulin pump devices.
Keywords: IEEE 11073-10419™, insulin pump, medical device communication, personal health
devices
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ISO/IEEE 11073-10419:2019(E)
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