EN ISO 11073-10421:2026

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
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
TO BECOME STAND ARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Email: stds.ipr@ieee.org
Website: www.ieee.org
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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ISO/IEEE 11073-10421:2024(en)
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ISO/IEEE 11073-10421:2024(en)
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ISO/IEEE 11073-10421:2024(en)
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ISO/IEEE 11073-10421:2024(en)
Participants
At the time this IEEE standard was completed, the Personal Health Device Working Group had the
following membership:
Daidi Zhong, Chair
Malcolm Clarke, Vice-Chair
Raymond Krasinski, Secretary
Karsten Aalders John T. Collins Rasmus Haahr
Charles R. Abbruscato Cory Condek Christian Habermann
Nabil Abujbara Todd H. Cooper Michael Hagerty
Maher Abuzaid Sandra Costanzo Jerry Hahn
James Agnew Douglas Coup Robert Hall
Manfred Aigner Nigel Cox Shu Han
Jorge Alberola Hans Crommenacker Nathaniel Hamming
David Aparisi Tomio Crosley Rickey L. Hampton
Lawrence Arne Allen Curtis Sten Hanke
Diego B. Arquillo Jesús Daniel Trigo Aki Harma
Serafin Arroyo David Davenport Jordan Hartmann
Muhammad Asim Russell Davis Kai Hassing
Kit August Sushil K. Deka Avi Hauser
Doug Baird Ciro de la Vega Nathaniel Heintzman
David Baker Jim Dello Stritto Charles Henderson
Anindya Bakshi Jun-Ho Her
Kent Dicks
Ananth Balasubramanian Hyoungho Do Timothy L. Hirou
Sunlee Bang Fangjie Dong Allen Hobbs
M. Jonathan Barkley Jonathan Dougherty Alex Holland
Gilberto Barrón Xiaolian Duan Arto Holopainen
David Bean Sourav Dutta Kris Holtzclaw
John Bell Jakob Ehrensvard Robert Hoy
Olivia Bellamou-Huet Fredrik Einberg Anne Huang
Rudy Belliardi Javier Escayola Calvo Guiling Huang
Daniel Bernstein Mark Estes Haofei Huang
George A. Bertos Leonardo Estevez Zhiyong Huang
Chris Biernacki Michael Faughn David Hughes
Ola Björsne Bosco T. Fernandes Robert D. Hughes
Thomas Blackadar Christoph Fischer Jiyoung Huh
Thomas Bluethner Morten Flintrup Hugh Hunter
Douglas P. Bogia Russell Foster Philip O. Isaacson
Eric Freudenthal
Xavier Boniface Atsushi Ito
Shannon Boucousis Matthias Frohner Michael Jaffe
Lyle G. Bullock, Jr. Ken Fuchs Praduman Jain
Bernard Burg Jing Gao Zongbo Jiang
Chris Burns Marcus Garbe Hu Jin
Jeremy Byford-Rew John Garguilo Danny Jochelson
Satya Calloji Liang Ge Akiyoshi Kabe
Carole C. Carey Rick Geimer Steve Kahle
Craig Carlson Igor Gejdos Tomio Kamioka
Santiago Carot-Nemesio Ferenc Gerbovics James J. Kang
Seungchul Chae Alan Godfrey Kei Kariya
Yao Chen Nicolae Goga Andy Kaschl
Jing Cheng Julian Goldman Junzo Kashihara
Peggy Chien Raul Gonzalez Gomez Ralph Kent
David Chiu Chris Gough Laurie M. Kermes
Jinyong Choi Channa Gowda Sanjay R. Kharche
Chia-Chin Chong Charles M. Gropper Ahmad Kheirandish
Jinhan Chung Amit Gupta Junhyung Kim
John A. Cogan Jeff Guttmacher
Minho Kim
ISO/IEEE 11073-10421:2024(en)
Min-Joon Kim Yoshiteru Nozoe Ivan Soh
Taekon Kim
Abraham Ofek Motoki Sone
Tetsuya Kimura Brett Olive Emily Sopensky
Michael J. Kirwan BegonyaOtal Rajagopalan Srinivasan
Alfred Kloos Marco Paleari Nicholas Steblay
Edward Koch Bud Panjwani Lars Steubesand
Jeongmee Koh Carl Pantiskas John (Ivo) Stivoric
Jean-Marc Koller Harry P. Pappas Hermanni Suominen
John Koon Hanna Park Lee Surprenant
Patty Krantz Jong-Tae Park Ravi Swami
Alexander Kraus Myungeun Park Ray Sweidan
Ramesh Krishna Phillip E. Pash Na Tang
Geoffrey Kruse TongBi Pei Haruyuyki Tatsumi
Falko Kuester Soren Petersen Isabel Tejero
Rafael Lajara
James Petisce Tom Thompson
Pierre Landau Peter Piction Jonas Tirén
Jaechul Lee
Michael Pliskin Janet Traub
JongMuk Lee Varshney Prabodh Gary Tschautscher
Kyong Ho Lee Jeff Price Masato Tsuchid
Rami Lee Harald Prinzhorn Ken Tubman
Sungkee Lee Lifei Qian Akib Uddin
Woojae Lee Harry Qiu Sunil Unadkat
Jing Li Tanzilur Rahman Fabio Urbani
Qiong Li Lin Ran Philipp Urbauer
Xiangchen Li Phillip Raymond Laura Vanzago
Patrick Lichter Terrie Reed Alpo Värri
Jisoon Lim Barry Reinhold Andrei Vasilateanu
Wei-Jung Lo Brian Reinhold Dalimar Velez
Charles Lowe Melvin I. Reynolds Martha Velezis
Don Ludolph John G. Rhoads Rudi Voon
Ling Luo Jeffrey S. Robbins Isobel Walker
Christian Luszick Chris Roberts
David Wang
Bob MacWilliams Moskowitz Robert Jerry P. Wang
Stefan Robert
Srikkanth Madhurbootheswaran Shiwei Wang
Miriam L. Makhlouf Scott M. Robertson Yao Wang
M. Sabarimalai Manikandan Timothy Robertson Yi Wang
Romain Marmot Sean Rocke Steve Warren
Sandra Martinez David Rosales Fujio Watanabe
Miguel Martínez de Bill Saltzstein Toru Watsuji
EsproncedaCámara Giovanna Sannino Kathleen Wible
Peter Mayhew Jose A. Santos-Cadenas Paul Williamson
Jim McCain Stefan Sauermann Jia-Rong Wu
LászlóMeleg John Sawyer Will Wykeham
Alexander Mense Alois Schloegl Ariton Xhafa
Behnaz Minaei Paul S. Schluter Ricky Yang
Jinsei Miyazaki Mark G. Schnell Melanie S. Yeung
Madhu Mohan Richard A. Schrenker Qiang Yin
Erik Moll Antonio Scorpiniti Done-Sik Yoo
KwangSeok Seo
Darr Moore Zhi Yu
Chris Morel Riccardo Serafin Jianchao Zeng
Sid Shaw
Carsten Mueglitz Jason Zhang
Soundharya Nagasubramanian Frank Shen Zerui Zhang
Alex Neefus Min Shih Shiwei Zhao
Trong-Nghia Nguyen-Dobinsky Mazen Shihabi Liang Zheng
Michael E. Nidd Redmond Shouldice Yuanhong Zhong
Jim Niswander Sternly K. Simon Qing Zhou
Hiroaki Niwamoto Marjorie Skubic Miha Zoubek
Thomas Norgall Robert Smith Szymon Zyskoter

ISO/IEEE 11073-10421:2024(en)
The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.
Robert Aiello Charles M. Gropper Scott Robertson
Cheryl Alexander Wang Werner Hoelzl Stefan Schlichting
Bjoern Andersen Piotr Karocki Walter Struppler
Pradeep Balachandran Stuart Kerry John Vergis
Malcolm Clarke Raymond Krasinski Yu Yuan
Javier Espina H. Moll Oren Yuen
Michael Faughn Rajesh Murthy Daidi Zhong
Ken Fuchs Bansi Patel
When the IEEE SA Standards Board approved this standard on 30 March 2023, it had the following
membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Sara R. Biyabani Joseph S. Levy Paul Nikolich
Doug Edward Howard Li Annette D. Reilly
Ramy Ahmed Fathy Johnny Daozhuang Lin Robby Robson
Guido R. Hiertz Gui Lin Lei Wang
Yousef Kimiagar Xiaohui Liu F. Keith Waters
Joseph L. Koepfinger* Kevin W. Lu Karl Weber
Thomas Koshy Daleep C. Mohla Philip B. Winston
John D. Kulick Andrew Myles Don Wright
*Member Emeritus
ISO/IEEE 11073-10421:2024(en)
IEEE Std 11073-10421-2023
Health Informatics—Device Interoperability—Part 10421: Personal Health Device Communication
Device Specialization—Peak Expiratory Flow Monitor (Peak Flow)
Introduction
This introduction is not part of IEEE Std 11073-10421™-2023, Health Informatics—Device Interoperability—Part
10421: Personal Health Device Communication—Device Specialization—Peak Expiratory Flow Monitor (Peak Flow).
The object classes and attributes in this standard are identified by nomenclature codes. Each code consists
of a reference identifier (RefID) string and an integer code value. By using a consistent nomenclature,
interoperability is enhanced as all implementations maintain the same semantic meaning for the numeric
codes. This standard leverages the existing nomenclature codes in IEEE Std 11073-10101™. Between this
standard, IEEE Std 11073-10101, ISO/IEEE 11073-20601, and other IEEE Std 11073-104zz, all required
nomenclature codes for implementation are documented. New codes may be defined in newer versions/
revisions of each of these documents. In the case of a conflict, where one term code has been assigned to
two separate semantic concepts with different RefIDs, in general, the oldest definition in actual use should
take precedence. The same policy applies when one RefID has two different code values assigned in
different specifications. The resolution of such conflicts will be determined through joint action by the
responsible working groups and other stakeholders, and any corrective action will be published as
corrigenda.
NOTE—In this standard, IEEE 11073-104zz is used to refer to the collection of device specialization standards that
utilize ISO/IEEE 11073-20601, where zz can be any number from 01 to 99, inclusive.
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.

ISO/IEEE 11073-10421:2024(en)
IEEE Std 11073-10421-2023
Health Informatics—Device Interoperability—Part 10421: Personal Health Device Communication
Device Specialization—Peak Expiratory Flow Monitor (Peak Flow)
Contents
1. Overview . 13
1.1 Scope . 13
1.2 Purpose . 13
1.3 Word usage . 14
2. Normative references . 14
3. Definitions, acronyms, and abbreviations . 14
3.1 Definitions . 14
3.2 Acronyms and abbreviations . 15
4. Introduction to ISO/IEEE 11073 personal health devices . 16
4.1 General . 16
4.2 Introduction to IEEE 11073-20601 modeling constructs . 16
4.3 Compliance with other standards . 17
5. Peak expiratory flow monitor device concepts and modalities . 18
5.1 General . 18
5.2 PEF . 18
6. Peak expiratory flow monitor domain information model. 20
6.1 Overview . 20
6.2 Class extensions . 20
6.3 Object instance diagram . 20
6.4 Types of configuration . 22
6.5 Medical device system object . 22
6.6 Numeric objects . 26
6.7 Real-time sample array objects . 36
6.8 PM-store objects . 39
6.9 Scanner objects . 39
6.10 Class extension objects . 39
6.11 Peak expiratory flow monitor information model extensibility rules . 39
7. Peak expiratory flow monitor service model . 39
7.1 General . 39
7.2 Object access services . 40
7.3 Object access event report services . 41
8. Peak expiratory flow monitor communication model . 41
8.1 Overview . 41
8.2 Communications characteristics . 41
8.3 Association procedure . 42
8.4 Configuring procedure . 44
8.5 Operating procedure . 46
8.6 Time synchronization . 47
9. Test associations . 47
9.1 Behavior with standard configuration . 47
9.2 Behavior with extended configurations. 48
10. Conformance . 48

ISO/IEEE 11073-10421:2024(en)
IEEE Std 11073-10421-2023
Health Informatics—Device Interoperability—Part 10421: Personal Health Device Communication
Device Specialization—Peak Expiratory Flow Monitor (Peak Flow)
10.1 Applicability . 48
10.2 Conformance specification . 48
10.3 Levels of conformance . 49
10.4 Implementation conformance statements (ICSs) . 49
Annex A (informative) Bibliography . 54
Annex B (normative) Any additional ASN.1 definitions . 55
Annex C (normative) Allocation of identifiers . 56
Annex D (informative) Message sequence examples . 57
Annex E (informative) Protocol data unit examples . 59
E.1 General . 59
E.2 Association information exchange . 59
E.3 Configuration information exchange . 62
E.4 GET MDS attributes service . 66
E.5 Data reporting . 67
E.6 Disassociation . 69
Annex F (informative) Revision History . 70

ISO/IEEE 11073-10421:2024(en)
IEEE Std 11073-10421-2023
Health Informatics—Device Interoperability—Part 10421: Personal Health Device Communication
Device Specialization—Peak Expiratory Flow Monitor (Peak Flow)
Health Informatics—Device Interoperability
Part 10421: Personal Health Device
Communication—Device
Specialization—Peak Expiratory Flow
Monitor (Peak Flow)
1. Overview
1.1 Scope
The scope of this standard is to establish 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
standard 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.
1.2 Purpose
This standard addresses a need for an openly defined
...