prEN ISO 11073-10421
(Main)Health informatics - Device interoperability - Part 10421: Personal Health Device Communication - Device Specialization- Peak expiratory flow monitor (peak flow) (ISO/IEEE FDIS 11073-10421:2024)
Health informatics - Device interoperability - Part 10421: Personal Health Device Communication - Device Specialization- Peak expiratory flow monitor (peak flow) (ISO/IEEE FDIS 11073-10421:2024)
This document establishes a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile 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 document defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-based spirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case. In the context of personal health devices, a peak flow meter is a device is used to measure the respiratory function of those managing respiratory conditions such as asthma and chronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring device and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic.
Medizinische Informatik - Interoperabilität von Geräten - Teil 10421: Kommunikation von Geräten für die persönliche Gesundheit - Gerätespezifikation - Monitor für den maximalen exspiratorischen Atemfluss (peak flow) (ISO/IEEE FDIS 11073-10421:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10421: Titre manque (ISO/IEEE FDIS 11073-10421:2024)
Ce document établit une définition normative de la communication entre des dispositifs personnels de télésanté de surveillance du débit de pointe (agents) 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 un travail effectué dans d'autres normes ISO/IEEE 11073, y compris la terminologie, les profils d'informations et les normes de profils d'applications 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.
Ce document définit un noyau commun de fonctionnalités d'un dispositif de surveillance de débit de pointe. Le cas d'utilisation est limité à une surveillance respiratoire personnelle et par conséquent n'inclut pas une spirométrie gérée dans un hôpital. Une surveillance continue et de grande précision (par exemple, en réponse à une urgence) n'est pas couverte par le domaine d'application du cas d'utilisation. Dans le contexte des dispositifs personnels de santé, un appareil de mesure du débit de pointe est un dispositif qui est utilisé pour mesurer la fonction respiratoire de personnes confrontées à des conditions respiratoires telles que l'asthme et des maladies broncho-pneumopatiques chroniques obstructives. La capacité à identifier le déclin d'un état respiratoire avant qu'une intervention précise ne soit nécessaire améliore la qualité de vie de l'individu tout en réduisant les coûts globaux des soins. Les données concernant l'état respiratoire sont collectées par un dispositif personnel de surveillance respiratoire et sont transmises à un centre de collecte de données afin qu'un prestataire de soins les examine et agisse en conséquence. Les données sont, par nature, épisodiques et sont transmises à des intervalles prévus ou lorsque la personne présente des symptômes.
Zdravstvena informatika - Interoperabilnost naprav - 10421. del: Komunikacija osebnih medicinskih naprav - Specialne naprave - Merilnik vršne vrednosti izdihanega zraka (ISO/IEEE FDIS 11073-10421:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2024
Zdravstvena informatika - Interoperabilnost naprav - 10421. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Merilnik vršne vrednosti
izdihanega zraka (ISO/IEEE FDIS 11073-10421:2024)
Health informatics - Device interoperability - Part 10421: Personal Health Device
Communication - Device Specialization- Peak expiratory flow monitor (peak flow)
(ISO/IEEE FDIS 11073-10421:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10421: Kommunikation von
Geräten für die persönliche Gesundheit - Gerätespezifikation - Monitor für den
maximalen exspiratorischen Atemfluss (peak flow) (ISO/IEEE FDIS 11073-10421:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10421: Titre manque
(ISO/IEEE FDIS 11073-10421:2024)
Ta slovenski standard je istoveten z: prEN ISO 11073-10421
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.
FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10421
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2024-03-15
Part 10421:
Personal Health Device
Voting terminates on:
2024-08-02
Communication — Device
Specialization- Peak expiratory flow
monitor (peak flow)
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEEE FDIS 1107310421:2024(en) © IEEE 2024
FINAL DRAFT
ISO/IEEE FDIS 11073-10421:2024(en)
International
Standard
ISO/IEEE
FDIS
11073-10421
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10421:
Personal Health Device
Voting terminates on:
Communication — Device
Specialization- Peak expiratory flow
monitor (peak flow)
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPORTING D OCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
© IEEE 2024
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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Published in Switzerland Reference number
ISO/IEEE FDIS 1107310421:2024(en)
© IEEE 2023
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10421:2024(en)
Foreword
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ISO/IEEE 11073-10421 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10421) 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/IEEE 11073-10421:2012), which has been
technically revised.
The main changes are as follows:
— added support for Base-Offset-Time;
— defined new standard configuration 0x0835;
— updated normative references, to refer to ISO/IEEE 11703-20601;
— updated version of this device specialization;
© IEEE 2023 – All rights reserved
iii
ISO/IEEE 11073-10421:2024(en)
— updated the association details based on the new version;
— updated the wording in 6.3 regarding the Observational;
— updated the examples in 8.4.2 and Annex E to indicate the support of BaseOffsetTime;
— updated the qualifier in MDS and other objects to recommend BaseOffsetTime; also updated the
description of the qualifiers in 6.5;
— added some text to 6.12 to further elaborate the DIM extensibility rule;
— corrected the use condition of GET MDS at E.4.1;
— updated the text in 8.5.2 regarding attribute-id-list, in order to be compliant with 20601-V4;
— added subclause 3.4 ‒ Compliance with other standards;
— removed the year in the bibliography to represent the latest version;
— extended Table 1 to specify qualifier details for all possible configurations;
— made the IEEE std 11073-10101 as normative reference;
— updated the wording at 1.3 and 4.1 regarding the precedence of nomenclature between 10101, 20601,
104xx, and this standard;
— updated the usage of nomenclature-version. Tied it with the corresponding protocol-version.
A list of all parts in the ISO/IEEE 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 2023 – All rights reserved
iv
IEEE Std 11073-10421™-2023
(Revision of IEEE Std 11073-10421-2010)
Health Informatics—Device Interoperability
Part 10421: Personal Health Device
Communication—Device
Specialization—Peak Expiratory Flow
Monitor (Peak Flow)
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 30 March 2023
IEEE SA Standards Board
ISO/IEEE 11073-10421:2024(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication is established in this standard 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.
Keywords: forced expiratory volume, IEEE 11073-10421™, medical device communication,
peak expiratory flow, peak expiratory flow monitor, peak flow, personal health devices
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