EN ISO 11073-10472:2012

Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012)

Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10472:2012 establishes a normative definition of communication between personal telehealth medication monitor 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. 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. ISO/IEEE 11073-10472:2012 defines a common core of communication functionality for personal telehealth medication monitor devices.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10472: Gerätespezifikation - Medikamentenmonitoring (ISO 11073-10472:2012)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10472: Spécialisation des dispositifs - Moniteur de surveillance de médication (ISO 11073-10472:2012)

Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication de dispositifs, l'ISO/IEEE 11073-10472:2012 établit une définition normative de la communication entre des dispositifs de surveillance de médication 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 les parties appropriées de normes existantes, y compris la terminologie et les modèles d'informations de l'ISO/IEEE 11073. 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. L'ISO/IEEE 11073-10472:2012 définit un noyau commun de fonctionnalités de communication pour les moniteurs de surveillance de médication.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10472. del: Specialne naprave - Naprava za nadzor jemanja zdravil (ISO 11073-10472:2012)

Ta standard v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 določa normativno opredelitev komunikacije med napravami za nadzor jemanja zdravil in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play. Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073 in informacijskimi modeli. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih ter v korist interoperabilnosti omejuje dvoumnost osnovnih okvirov. Ta standard določa skupno jedro komunikacijske funkcionalnosti za naprave za nadzor jemanja zdravil. Naprave za nadzor jemanja zdravil so v tem okviru opredeljene kot naprave, ki lahko določijo in (upravljalni napravi) sporočijo ukrepe uporabnikovega upoštevanja jemanja zdravil.

General Information

• Status: Published
• Publication Date: 31-Oct-2012
• Withdrawal Date: 30-May-2013
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 2 - Terminology and knowledge representation
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Nov-2012
• Completion Date: 01-Nov-2012
• Ref Project: SIST EN ISO 11073-10472:2013 - Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012)

Relations

• Revised: prEN ISO/IEEE 11073-10472 - Health informatics - Device interoperability - Part 10472: Personal Health Device Communication - Device Specialization - Medication Monitor (ISO/IEEE FDIS 11073-10472:2024)
• Effective Date: 08-Nov-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2013
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10472. del:
Specialne naprave - Naprava za nadzor jemanja zdravil (ISO 11073-10472:2012)
Health Informatics - Personal health device communication - Part 10472: Device
specialization - Medication monitor (ISO 11073-10472:2012)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10472: Gerätespezifikation - Medikamentenmonitoring (ISO 11073-10472:2012)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10472: Spécialisation de dispositif - Moniteur de médication (ISO 11073-10472:2012)
Ta slovenski standard je istoveten z: EN ISO 11073-10472:2012
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.

EUROPEAN STANDARD
EN ISO 11073-10472
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health Informatics - Personal health device communication -
Part 10472: Device specialization - Medication monitor (ISO
11073-10472:2012)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 10472: Spécialisation des die persönliche Gesundheit - Teil 10472:
dispositifs - Moniteur de surveillance de médication (ISO Gerätespezifikation - Medikamentenmonitoring (ISO 11073-
11073-10472:2012) 10472:2012)
This European Standard was approved by CEN on 20 October 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 11073-10472:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11073-10472:2012) 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 May 2013, and conflicting national standards shall be withdrawn at the
latest by May 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 11073-10472:2012 has been approved by CEN as a EN ISO 11073-10472:2012 without any
modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10472
First edition
2012-11-01
Health informatics — Personal health
device communication —
Part 10472:
Device specialization — Medication
monitor
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10472: Spécialisation de dispositif — Moniteur de médication

Reference number
ISO/IEEE 11073-10472:2012(E)
©
ISO 2012
©
IEEE 2012
ISO/IEEE 11073-10472:2012(E)
©  ISO 2012
©  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.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc.
Case postale 56  CH-1211 Geneva 20 3 Park Avenue, New York  NY 10016-5997, USA
Tel. + 41 22 749 01 11 E-mail [e-mail]
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E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © IEEE 2012 – All rights reserved

ISO/IEEE 11073-10472:2012(E)
Contents
1. Overview . 1

1.1 Scope . 1
1.2 Purpose . 2
1.3 Context . 2
2. Normative references. 2
3. Definitions, acronyms, and abbreviations . 2
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 IEEE 11073-20601 modeling constructs . 4
5. Medication monitor device concepts and modalities. 5
5.1 General . 5
5.2 Model usage examples. 6
5.3 Medication dispensed . 7
5.4 Status reporter. 8
5.5 User feedback . 8
5.6 Usage patterns. 9
6. Medication monitor domain information model. 9
6.1 Overview . 9
6.2 Class extensions. 9
6.3 Object instance diagram . 10
6.4 Types of configuration. 11
6.5 Medical device system object. 12
6.6 Numeric objects. 16
6.7 Real-time sample array objects. 22
6.8 Enumeration objects . 22
6.9 PM-store objects. 27
6.10 Scanner objects. 30
6.11 Class extension objects. 31
6.12 Medication monitor information model extensibility rules . 31
7. Medication monitor service model . 31
7.1 General . 31
7.2 Object access services. 31
7.3 Object access event report services . 32
8. Medication monitor communication model. 33
8.1 Overview . 33
8.2 Communications characteristics . 33
8.3 Association procedure . 33
8.4 Configuring procedure. 35
8.5 Operating procedure . 41
8.6 Time synchronization . 42
9. Test associations. 42
© IEEE 2012 – All rights reserved iii

ISO/IEEE 11073-10472:2012(E)
9.1 Behavior with standard configuration. 42
9.2 Behavior with extended configurations . 43
10. Conformance . 43
10.1 Applicability . 43
10.2 Conformance specification . 43
10.3 Levels of conformance . 44
10.4 Implementation conformance statements . 44
Annex A (informative) Bibliography . 50
Annex B (normative) Any additional ASN.1 definitions . 51
Annex C (normative) Allocation of identifiers. 52
Annex D (informative) Message sequence examples. 53
Annex E (informative) Protocol data unit examples .
...