EN ISO 11073-10424:2016

SLOVENSKI STANDARD
01-december-2016
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10424. del:
Specialne naprave - Naprava za zdravljenje motenj dihanja v spanju (ISO 11073-
10424:2016)
Health informatics - Personal health device communication - Part 10424: Device
Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) (ISO 11073-
10424:2016)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10424: Gerätespezifikation - Schlafapnoe-Atemtherapiegeräte (ISO 11073-
10424:2016)
Informatique de la santé - Communication entre dispositifs de santé personnels - Partie
10424: Spécialisation de dispositif - Équipement de thérapie respiratoire de l'apnée du
sommeil (SABTE) (ISO 11073-10424:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10424:2016
ICS:
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 11073-10424
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Personal health device
communication - Part 10424: Device specialization - Sleep
apnoea breathing therapy equipment (SABTE) (ISO/IEEE
11073-10424:2016)
Informatique de la santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10424: für die persönliche Gesundheit - Teil 10424:
Spécialisation de dispositif - Équipement de thérapie Gerätespezifikation - Schlafapnoe-Atemtherapiegeräte
respiratoire de l'apnée du sommeil (SABTE) (ISO/IEEE (ISO/IEEE 11073-10424:2016)
11073-10424:2016)
This European Standard was approved by CEN on 21 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 11073-10424:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11073-10424:2016) 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 11073-10424:2016 has been approved by CEN as EN ISO 11073-10424:2016
without any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10424
First edition
2016-06-15
Health informatics — Personal health
device communication —
Part 10424:
Device Specialization — Sleep Apnoea
Breathing Therapy Equipment (SABTE)
Informatique de santé — Communication entre dispositifs de santé
personnels
Partie 10424: Spécialisation de dispositif — Équipement de thérapie
respiratoire de l'apnée du sommeil (SABTE)

Reference number
ISO/IEEE 11073-10424:2016(E)
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ISO 2016
©
IEEE 2014
ISO/IEEE 11073-10424:2016(E)
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ISO/IEEE 11073-10424:2016(E)
Foreword
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ISO/IEEE 11073-10424 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
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© IEEE 2014 – All rights reserved iii

ISO/IEEE 11073-10424:2016(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of the communication between sleep apnoea breathing
therapy equipment (SABTE) 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, 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. This standard defines a common core of communication functionality for SABTE.
In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a
patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the
patient. SABTE is primarily used in the home health-care environment by a lay operator without
direct professional supervision.

Keywords: IEEE 11073-10424™, medical device communication, personal health devices, sleep
apnoea breathing therapy equipment (SABTE)

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