EN ISO 11073-10406:2012
(Main)Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in ISO/IEEE11073-10406:2012.
Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena.
ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate).
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10406: Gerätespezifikation - Basiselektrokardiogramm (EKG) (EKG mit 1 bis 3 Ableitungen) (ISO/IEEE 11073-10406:2012)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10406: Spécialisation des dispositifs - Électrocardiographe de base (ECG) (ECG 1 à 3) (ISO/IEEE 11073-10406:2012)
Dans le contexte de la famille de normes ISO/IEEE 11073 relative à la communication entre dispositifs, l'ISO/IEEE 10073-10406:2012 établit une définition normative de la communication entre les électrocardiographes (ECG) personnels de base et les gestionnaires (par exemple, téléphones cellulaires, ordinateurs personnels, appareils de santé personnels et boîtiers décodeurs) de manière à permettre une interopérabilité du type prêt à l'emploi.
Elle s'appuie sur les sections appropriées de normes existantes, y compris la terminologie de l'ISO/IEEE 11073 et les modèles d'informations de l'IEEE 11073-20601. Elle spécifie l'utilisation de codes de terme, de formats et de comportements spécifiques dans les environnements de télésanté, réduisant l'optionalité des cadres de base au profit de l'interopérabilité. L'ISO/IEEE 10073‑10406:2012 définit un tronc commun de fonctionnalités de communication pour les dispositifs personnels de télésanté ECG de base (ECG 1 à 3). Les dispositifs ECG de surveillance se distinguent des équipements ECG de diagnostic en ce qu'ils comportent un support pour dispositifs ECG portables, ce qui limite le nombre de fils pris en charge par l'équipement à trois, et qu'ils n'ont pas besoin que l'activité électrique détectée soit annotée ou analysée pour déterminer les phénomènes cardiaques connus.
L'ISO/IEEE 10073‑10406:2012 est conforme au cadre de base et permet de procéder à une mise en ?uvre multifonction en suivant les multiples spécialisations de dispositif (par exemple, ECG et rythme respiratoire).
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10406. del: Specialne naprave - Osnovni elektrokardiograf (EKG) (od 1- do 3-odvodni EKG) (ISO/IEEE 11073-10406:2012)
Ta standard v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 določa normativno opredelitev komunikacije med osebnimi osnovnimi elektrokardiografi (EKG) in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play (PnP, »vstavi in poženi«). Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073 in z informacijskimi modeli iz standarda IEEE 11073-20601. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih ter v korist interoperabilnosti omejuje opcionalnost osnovnih okvirov. Ta standard določa skupno jedro komunikacijske funkcionalnosti za osebne telemedicinske naprave EKG (z 1 do 3 odvodi). Nadzorne naprave EKG se razlikujejo od diagnostične opreme EKG, pri čemer se vključi podpora za nosljive naprave EKG, omeji število odvodov, ki jih naprava podpira, na tri in se ne zahteva zmogljivosti beleženja ali analiziranja zaznanega električnega delovanja za določitev znanih načinov delovanja srca. Ta standard je v skladu z osnovnim okvirom in omogoča večfunkcijsko delovanje s specializacijami za več naprav (npr. EKG in hitrost dihanja).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2013
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10406. del:
Specialne naprave - Osnovni elektrokardiograf (EKG) (od 1- do 3-odvodni EKG)
(ISO/IEEE 11073-10406:2012)
Health informatics - Personal health device communication - Part 10406: Device
specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-
10406:2012)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10406: Gerätespezifikation - Basiselektrokardiogramm (EKG) (EKG mit 1 bis 3
Ableitungen) (ISO/IEEE 11073-10406:2012)
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6SpFLDOLVDWLRQGHVGLVSRVLWLIVeOHFWURFDUGLRJUDSKHGHEDVH (&* (&*j
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Ta slovenski standard je istoveten z: EN ISO 11073-10406:2012
ICS:
11.040.50 Radiografska oprema Radiographic 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.
EUROPEAN STANDARD
EN ISO 11073-10406
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2012
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 10406: Device specialization - Basic electrocardiograph
(ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 10406: Spécialisation des die persönliche Gesundheit - Teil 10406:
dispositifs - Électrocardiographe de base (ECG) (ECG 1 à Gerätespezifikation - Basiselektrokardiogramm (EKG)
3) (ISO/IEEE 11073-10406:2012) (EKG mit 1 bis 3 Ableitungen) (ISO/IEEE 11073-
10406:2012)
This European Standard was approved by CEN on 30 November 2012.
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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10406:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11073-10406:2012) 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 June 2013, and conflicting national standards shall be withdrawn at
the latest by June 2013.
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 organisations 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 11073-10406:2012 has been approved by CEN as a EN ISO 11073-10406:2012 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10406
First edition
2012-12-01
Health informatics — Personal health
device communication —
Part 10406:
Device specialization — Basic
electrocardiograph (ECG)
(1- to 3-lead ECG)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10406: Spécialisation des dispositifs — Électrocardiographe de
base (ECG) (ECG 1 à 3)
Reference number
ISO/IEEE 11073-10406:2012(E)
©
IEEE 2012
ISO/IEEE 11073-10406:2012(E)
© IEEE 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
address below.
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Published in Switzerland
ii © IEEE 2012 – All rights reserved
ISO/IEEE 11073-10406:2012(E)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 Context . 2
2. Normative references. 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 3
4. Introduction to ISO/IEEE 11073 personal health devices . 4
4.1 General . 4
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs. 4
4.3 Compliance with other standards. 5
5. Basic ECG (1- to 3-lead ECG) device concepts and modalities. 6
5.1 General . 6
5.2 ECG waveform. 6
5.3 R-R interval . 6
5.4 Heart rate . 7
6. Basic ECG (1- to 3-lead ECG) domain information model.7
6.1 Overview . 7
6.2 Class extensions. 7
6.3 Object instance diagram . 7
6.4 Types of configuration. 8
6.5 Profiles. 9
6.6 Medical device system object. 11
6.7 Numeric objects. 15
6.8 Real-time sample array objects. 18
6.9 Enumeration objects . 19
6.10 PM-store objects. 22
6.11 Scanner objects. 29
6.12 Class extension objects. 32
6.13 Basic ECG (1- to 3-lead ECG) information model extensibility rules . 32
7. Basic ECG (1- to 3-lead ECG) service model . 32
7.1 General . 32
7.2 Object access services. 32
7.3 Object access event report services . 35
8. Basic ECG (1- to 3-lead ECG) communication model.35
8.1 Overview . 35
8.2 Communications characteristics . 36
8.3 Association procedure . 36
8.4 Configuring procedure. 38
8.5 Operating procedure . 39
8.6 Time synchronization . 40
© IEEE 2012 – All rights reserved iii
ISO/IEEE 11073-10406:2012(E)
9. Test associations. 40
9.1 Behavior with standard configuration. 40
9.2 Behavior with extended configurations . 41
10. Conformance . 41
10.1 Applicability . 41
10.2 Conformance specification . 41
10.3 Levels of conformance . 42
10.4 Implementation conformance statements . 42
Annex A (informative) Bibliography . 47
Annex B (normative) Any additional ASN.1 definitions . 48
Annex C (normative) Allocation of identifiers.
...
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