EN ISO 11073-10421:2012

Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in ISO/IEEE 11073-10421:2012 between personal telehealth peak expiratory flow monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors is specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality is defined for personal telehealth peak expiratory flow monitor devices.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10421: Gerätespezifikation - Monitor für den maximalen exspiratorischen Atemfluss (peak flow) (ISO/IEEE 11073-10421:2012)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10421: Spécialisation des dispositifs - Moniteur de surveillance du débit expiratoire de pointe (débit de pointe) (ISO 11073-10421:2012)

Dans le contexte de la famille de Normes ISO/IEEE 11073 relatives à la communication de dispositifs, l'ISO/IEEE 11073-10421:2012 établit une définition normative de la communication entre les dispositifs personnels d'analyse de composition corporelle et des gestionnaires (par exemple, des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé, des boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Elle s'appuie sur un travail effectué dans d'autres normes ISO/IEEE 11073, y compris la terminologie, les profils d'informations, les normes de profils d'applications et les normes de transports existants. 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. Elle définit un noyau commun de fonctionnalités d'un dispositif de surveillance de débit de pointe.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10421. del: Specialne naprave - Merilnik vršne vrednosti izdihanega zraka (ISO 11073-10421:2012)

Področje uporabe tega standarda določa normativno opredelitev komunikacije med osebnimi telemedicinskimi napravami za merjenje vršne vrednosti izdihanega zraka in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami in 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 ter v korist interoperabilnosti omejuje opcionalnost osnovnih okvirov. Ta standard določa skupno jedro funkcionalnosti za napravo za merjenje vršne vrednosti. Primer uporabe je omejen na osebno merjenje izdihanega zraka in zato ne vključuje spirometrije, ki se izvaja v bolnišnici. Trajno merjenje in merjenje v primeru visoke akutnosti (npr. v okviru odziva na izredne razmere) ne spadata na področje uporabe tega primera. Merilnik vršne vrednosti izdihanega zraka se v okviru osebnih medicinskih naprav uporablja za merjenje dihalne funkcije pri ljudeh z boleznimi dihal, kot sta astma in kronična obstruktivna pljučna bolezen. Sposobnost opredelitve slabitve dihanja pred potrebo po akutnemu posredovanju izboljša kakovost življenja posameznika ter niža skupne stroške oskrbe. Osebna naprava za merjenje izdihanega zraka zbira podatke o stanju dihanja in jih posreduje v osrednjo zbirko podatkov, v okviru katere te podatke pregleda izvajalec zdravstvenih storitev in ukrepa v skladu z njimi. Podatki so po naravi občasni in se posredujejo v določenih intervalih ali kadar oseba kaže znake slabitve dihanja.

General Information

• Status: Published
• Publication Date: 31-Oct-2012
• Withdrawal Date: 30-May-2013
• ICS: 11.040.55 - Diagnostic equipment
• 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 11073-10421:2013 - Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012)

Relations

• Revised: prEN ISO 11073-10421 - Health informatics - Device interoperability - Part 10421: Personal Health Device Communication - Device Specialization- Peak expiratory flow monitor (peak flow) (ISO/IEEE FDIS 11073-10421:2024)
• Effective Date: 08-Nov-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2013
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10421. del:
Specialne naprave - Merilnik vršne vrednosti izdihanega zraka (ISO 11073-
10421:2012)
Health informatics - Personal health device communication - Part 10421: Device
specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10421: Spécialisation de dispositif - Moniteur du flux rexpiratoire de crête (flux de crête)
(ISO 11073-10421:2012)
Ta slovenski standard je istoveten z: EN ISO 11073-10421:2012
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD 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.

EUROPEAN STANDARD
EN ISO 11073-10421
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 10421: Device specialization - Peak expiratory flow monitor
(peak flow) (ISO 11073-10421:2012)
Informatique de santé - Communication entre dispositifs de
santé personnels - Partie 10421: Spécialisation des
dispositifs - Moniteur de surveillance du débit expiratoire de
pointe (débit de pointe) (ISO 11073-10421:2012)
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 11073-10421:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11073-10421:2012) 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 11073-10421:2012 has been approved by CEN as a EN ISO 11073-10421:2012 without any
modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10421
First edition
2012-11-01
Health informatics — Personal health
device communication —
Part 10421:
Device specialization — Peak expiratory
flow monitor (peak flow)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10421: Spécialisation de dispositif — Moniteur du flux rexpiratoire
de crête (flux de crête)
Reference number
ISO/IEEE 11073-10421:2012(E)
©
ISO 2012
©
IEEE 2012
ISO/IEEE 11073-10421:2012(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]
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © IEEE 2012 – All rights reserved

ISO/IEEE 11073-10421:2012(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 ISO/IEEE 11073-20601 modeling constructs . 4
5. Peak expiratory flow monitor device concepts and modalities. 5
5.1 General . 5
5.2 PEF . 5
6. Peak expiratory flow monitor domain information model . 7
6.1 Overview . 7
6.2 Class extensions . 7
6.3 Object instance diagram . 7
6.4 Types of configuration . 9
6.5 Medical device system object . 9
6.6 Numeric objects . 13
6.7 Real-time sample array objects . 20
6.8 Enumeration objects . 20
6.9 PM-store objects . 22
6.10 Scanner objects . 22
6.11 Class extension objects . 22
6.12 Peak expiratory flow monitor information model extensibility rules . 22
7. Peak expiratory flow monitor service model . 22
7.1 General . 22
7.2 Object access services. 22
7.3 Object access event report services . 23
© IEEE 2012 – All rights reserved iii

ISO/IEEE 11073-10421:2012(E)
8. Peak expiratory flow monitor communication model . 24
8.1 Overview . 24
8.2 Communications characteristics . 24
8.3 Association procedure . 24
8.4 Configuring procedure . 26
8.5 Operating procedure . 28
8.6 Time synchronization . 29
9. Test associations . 29
9.1 Behavior with standard configuration . 29
9.2 Behavior with extended configurations . 30
10. Conformance . 30
10.1 Applicability . 30
10.2 Conformance specification . 30
10.3 Levels of conformance . 30
10.4 Implementation conformance statements . 31
Annex A (informative) Bibliography . 36
Annex B (normative) Any additional ASN.1 definitions . 37
Annex C (normative) Allocation of identifiers . 38
Annex D (informative) Message sequence examples . 39
Annex E (informative) Protocol data unit examples . 41
Annex F (informative) IEEE list of participants . 52
iv © IEEE 2012 – All rights reserved

ISO/IEEE 11073-10421:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technic
...