SIST EN ISO/IEEE 11073-10408:2023

SLOVENSKI STANDARD
oSIST prEN ISO/IEEE 11073-10408:2022
01-september-2022
Zdravstvena informatika - Interoperabilnost naprav - 10408. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Termometer (ISO/IEEE/FDIS
11073-10408:2022)
Health informatics - Device interoperability - Part 10408: Personal health device
communication - Device specialization - Thermometer (ISO/IEEE/FDIS 11073-
10408:2022)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10408: Gerätespezifikation - Thermometer (ISO/IEEE/FDIS 11073-10408:2022)
Informatique de santé - Interopérabilité des dispositifs - Partie 10408: Communication
entre dispositifs de santé personnels - Spécialisation des dispositifs - Thermomètre
(ISO/IEEE/FDIS 11073-10408:2022)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10408
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO/IEEE 11073-10408:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO/IEEE 11073-10408:2022

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oSIST prEN ISO/IEEE 11073-10408:2022
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-10408
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2022-06-16
Part 10408:
Voting terminates on:
Personal health device communication
2022-11-03
— Device specialization —
Thermometer
Informatique de santé — Interopérabilité des dispositifs —
Partie 10408: Communication entre dispositifs de santé personnels —
Spécialisation des dispositifs — Thermomètre
ISO/CEN PARALLEL PROCESSING
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/IEEE FDIS 11073-10408:2022(E)
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. © IEEE 2022

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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE FDIS 11073-10408:2022(E)
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-10408
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10408:
Voting terminates on:
Personal health device communication
— Device specialization —
Thermometer
Informatique de santé — Interopérabilité des dispositifs —
Partie 10408: Communication entre dispositifs de santé personnels —
Spécialisation des dispositifs — Thermomètre
COPYRIGHT PROTECTED DOCUMENT
ISO/CEN PARALLEL PROCESSING
© IEEE 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
Institute of Electrical and Electronics Engineers, Inc
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
3 Park Avenue, New York
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
NY 10016-5997, USA
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: stds.ipr@ieee.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/IEEE FDIS 11073­10408:2022(E)
Website: www.ieee.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © IEEE 2022 – All rights reserved
NATIONAL REGULATIONS. © IEEE 2022

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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE FDIS 11073-10408:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted (see www.iso.org/directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its
standards through a consensus development process, approved by the American National Standards
Institute, which brings together volunteers representing varied viewpoints and interests to achieve the
final product. Volunteers are not necessarily members of the Institute and serve without compensation.
While the IEEE administers the process and establishes rules to promote fairness in the consensus
development process, the IEEE does not independently evaluate, test, or verify the accuracy of any of the
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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ISO/IEEE 11073-10408 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10408-2019) 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 11073-10408:2010), which has been
technically revised.
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 2019 – All rights reserved iii

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oSIST prEN ISO/IEEE 11073-10408:2022

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oSIST prEN ISO/IEEE 11073-10408:2022
IEEE Std 11073-10408™-2019
(Revision of IEEE Std 11073-10408-2008)



Health informatics—Personal health device communication
Part 10408: Device specialization—
Thermometer
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society


Approved 7 November 2019
IEEE SA Standards Board

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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, this standard establishes a normative definition of communication between
personal telehealth thermometer 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. 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. This standard
defines a common core of communication functionality for personal telehealth thermometer
devices.

Keywords: IEEE 11073-10408™, medical device communication, personal health devices,
thermometer


•





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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)
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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)
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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)
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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)

Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Co-chair
Michael J. Kirwan, Co-chair
Karsten Aalders Rick Geimer
James Cheng
Charles R. Abbruscato
Peggy Chien Igor Gejdos
Nabil Abujbara David Chiu Ferenc Gerbovics
Maher Abuzaid Jinyong Choi Alan Godfrey
James Agnew Chia-Chin Chong Nicolae Goga
Haidar Ahmad Saeed A. Choudhary Julian Goldman
Manfred Aigner Jinhan Chung Raul Gonzalez Gomez
Jorge Alberola Malcolm Clarke Chris Gough
Murtaza Ali John A. Cogan Channa Gowda
Rolf Ambuehl John T. Collins Charles M. Gropper
David Aparisi Cory Condek Amit Gupta
Paolo Ariano Todd H. Cooper Jeff Guttmacher
Lawrence Arne David Cornejo Rasmus Haahr
Diego B. Arquillo Douglas Coup Christian Habermann
Serafin Arroyo Nigel Cox Michael Hagerty
Muhammad Asim Jerry Hahn
Hans Crommenacker
Merat Bagha Tomio Crosley Robert Hall
Doug Baird Allen Curtis Shu Han
David Baker Ndifor Cyril Fru Nathaniel Hamming
Anindya Bakshi Jesús Daniel Trigo Rickey L. Hampton
Ananth Balasubramanian Eyal Dassau Sten Hanke
Sunlee Bang David Davenport Aki Harma
M. Jonathan Barkley Russell Davis Jordan Hartmann
Gilberto Barrón Sushil K. Deka Kai Hassing
David Bean Ciro de la Vega Wolfgang Heck
John Bell Pedro de-las-Heras-Quiros Nathaniel Heintzman
Rudy Belliardi Jim Dello Stritto Charles Henderson
Kathryn M. Bennett Matthew d’Entremont Jun-Ho Her
Daniel Bernstein Kent Dicks Helen B. Hernandez
George A. Bertos Hyoungho Do Takashi Hibino
Chris Biernacki Alistair Donaldson
Timothy L. Hirou
Xiaolian Duan
Ola Björsne Allen Hobbs
Thomas Blackadar Brian Dubreuil Alex Holland
Marc Blanchet Sourav Dutta Arto Holopainen
Thomas Bluethner Jakob Ehrensvard Kris Holtzclaw
Douglas P. Bogia Fredrik Einberg Xinyi Hong
Xavier Boniface Michihiro Enokida Robert Hoy
Shannon Boucousis Javier Escayola Calvo Frank Hsu
Julius Broma Mark Estes Anne Huang
Lyle G. Bullock, Jr. Leonardo Estevez Sen-Der Huang
Bernard Burg Roger Feeley Ron Huby
Chris Burns Hailing Feng David Hughes
Anthony Butt Bosco T. Fernandes Robert D. Hughes
Jeremy Byford-Rew Christoph Fischer Jiyoung Huh
Satya Calloji Morten Flintrup
Hugh Hunter
Joseph W. Forler
Xiaoying Cao Hitoshi Ikeda
Carole C. Carey Russell Foster Yutaka Ikeda
Craig Carlson Eric Freudenthal Philip O. Isaacson
Santiago Carot-Nemesio Matthias Frohner Atsushi Ito
Randy W. Carroll Ken Fuchs Michael Jaffe
Simon Carter Jing Gao Praduman Jain
Seungchul Chae Qi Gao Danny Jochelson
Rahul Chauhan Marcus Garbe Phaneeth Junga
Wenjuan Chen John Garguilo Akiyoshi Kabe
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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)

Steve Kahle Peter Mayhew Fatemeh Saki
Tomio Kamioka Bill Saltzstein
Jim McCain
James J. Kang
László Meleg Benedikt Salzbrunn
Kei Kariya Alexander Mense Giovanna Sannino
Andy Kaschl Behnaz Minaei Jose A. Santos-Cadenas
Junzo Kashihara Jinsei Miyazaki Stefan Sauermann
Kohichi Kashiwagi Erik Moll John Sawyer
Ralph Kent Darr Moore Guillaume Schatz
Laurie M. Kermes Carsten Mueglitz Alois Schloegl
Ikuo Keshi Piotr Murawski Paul S. Schluter
Ahmad Kheirandish Soundharya Nagasubramanian Lars Schmitt
Junhyung Kim Jae-Wook Nah Mark G. Schnell
Minho Kim Alex Neefus Richard A. Schrenker
Min-Joon Kim Trong-Nghia Nguyen-Dobinsky Antonio Scorpiniti
Taekon Kim Michael E. Nidd KwangSeok Seo
Tetsuya Kimura Riccardo Serafin
Tetsu Nishimura
Alfred Kloos
Jim Niswander Sid Shaw
Jeongmee Koh
Hongliang Niu Frank Shen
Jean-Marc Koller Hiroaki Niwamoto Min Shih
Fei Kong Thomas Norgall Mazen Shihabi
John Koon Anand Noubade Redmond Shouldice
Patty Krantz Yoshiteru Nozoe Sternly K. Simon
Raymond Krasinski Abraham Ofek Marjorie Skubic
Alexander Kraus Brett Olive Robert Smith
Ramesh Krishna BegonyaOtal Ivan Soh
Geoffrey Kruse Marco Paleari Motoki Sone
Falko Kuester Charles Palmer Emily Sopensky
Rafael Lajara Bud Panjwani Rajagopalan Srinivasan
Shing C. B. Lam Carl Pantiskas Andreas Staubert
Pierre Landau Harry P. Pappas Nicholas Steblay
Jaechul Lee Hanna Park Lars Steubesand
Jong-Tae Park
JongMuk Lee John (Ivo) Stivoric
Kyong Ho Lee Myungeun Park Raymond A. Strickland
Rami Lee Soojun Park Chandrasekaran Subramaniam
Sungkee Lee Phillip E. Pash Hermanni Suominen
Woojae Lee TongBi Pei Lee Surprenant
Yonghee Lee Lucian Pestritu Ravi Swami
Joe Lenart Soren Petersen Ray Sweidan
Kathryn A. Lesh James Petisce Jin Tan
Catherine Li Peter Piction Yi Tang
Jingli Li Michael Pliskin Haruyuyki Tatsumi
Qiong Li Varshney Prabodh Isabel Tejero
Xiangchen Li Jeff Price John W. Thomas
Zhuofang Li Harald Prinzhorn Jonas Tirén
Patrick Lichter Harry Qiu Alexandra Todiruta
Jisoon Lim Arif Rahman
Janet Traub
Joon-Ho Lim Tanzilur Rahman
Gary Tschautscher
Steve Ray
John Lin Masato Tsuchid
Hongliang Niu Phillip Raymond Ken Tubman
Xiaoming Liu Terrie Reed Yoshihiro Uchida
Wei-Jung Lo Tim Reilly Akib Uddin
Charles Lowe Barry Reinhold Sunil Unadkat
Don Ludolph Brian Reinhold Fabio Urbani
Christian Luszick Melvin I. Reynolds Philipp Urbauer
Songdong Lv John G. Rhoads Laura Vanzago
Bob MacWilliams Jeffrey S. Robbins Alpo Värri
Srikkanth Madhurbootheswaran Chris Roberts Andrei Vasilateanu
Miriam L. Makhlouf Moskowitz Robert Dalimar Velez
Romain Marmot Scott M. Robertson Martha Velezis
Sandra Martinez Timothy Robertson Rudi Voon
David Rosales Barry Vornbrock
Miguel Martínez de
Gary Sagiv Isobel Walker
EsproncedaCámara
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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)

David Wang Kathleen Wible Qiang Yin
Jerry P. Wang Paul Williamson Done-Sik Yoo
Yao Wang Jan Wittenber Jianchao Zeng
Yi Wang Jia-Rong Wu Jason Zhang
Steve Warren Will Wykeham Zhiqiang Zhang
Fujio Watanabe Ariton Xhafa Thomas Zhao
Toru Watsuji Qifeng Yan Jia Zheng
Mike Weng Ricky Yang Miha Zoubek
Yuefeng Weng Shaoqin Ye Szymon Zyskoter
Melanie S. Yeung

The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.

Bjoern Andersen Noriyuki Ikeuchi Beth Pumo
Lyle G. Bullock, Jr. Atsushi Ito
Stefan Schlichting
Keith Chow Raj Jain Janek Schumann
Malcolm Clarke Piotr Karocki Walter Struppler
David Fuschi Raymond Krasinski Oren Yuen
Randall Groves H. Moll Janusz Zalewski
Werner Hoelzl Daidi Zhong


When the IEEE SA Standards Board approved this standard on 7 November 2019, it had the following
membership:

Gary Hoffman, Chair
Ted Burse, Vice Chair
Jean-Philippe Faure, Past Chair
Konstantinos Karachalios, Secretary
Masayuki Ariyoshi David J. Law Annette Reilly
Stephen D. Dukes Joseph Levy Dorothy Stanley
J. Travis Griffith Howard Li Sha Wei
Guido Hiertz Xiaohui Liu Phil Wennblom
Christel Hunter Kevin Lu Philip Winston
Joseph L. Koepfinger* Daleep Mohla Howard Wolfman
Thomas Koshy Andrew Myles Feng Wu
John D. Kulick Jingyi Zhou

*Member Emeritus





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oSIST prEN ISO/IEEE 11073-10408:2022
ISO/IEEE 11073-10408:2022(E)


Introduction
This introduction is not part of IEEE Std 11073-10408-2019, Health informatics—Personal health device
communication—Part 10408: Device specialization—Thermometer.

ISO/IEEE 11073 standards enable communication between medical devices and external computer
a
systems. This document uses the optimized framework created in IEEE Std 11073-20601 and describes a
specific, interoperable communication approach for thermometers. These standards align with and draw on
the existing clinically focused standards to provide support for communication of data from clinical or
personal health devices.













































a
Information on references can be found in Clause 2.
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Copyright © 2019 IEEE. A
...