ISO/IEEE 11073-10408:2022

INTERNATIONAL ISO/IEEE
STANDARD 11073-10408
Second edition
2022-12
Health informatics — Device
interoperability —
Part 10408:
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
Reference number
© IEEE 2019
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ii
© IEEE 2019 – All rights reserved

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ISO/IEEE 11073-10408 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
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Organization cooperation agreement between ISO and IEEE, by Technical Committee ISO/TC 215, Health
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© IEEE 2019 – All rights reserved iii

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
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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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
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
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
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.
Contents
1. Overview .12
1.1 Scope .12
1.2 Purpose .12
1.3 Context .12
1.4 Word usage .13
2. Normative references .13
3. Definitions, acronyms, and abbreviations .14
3.1 Definitions .14
3.2 Acronyms and abbreviations.14
4. Introduction to ISO/IEEE 11073 personal health devices .15
4.1 General .15
4.2 Introduction to IEEE 11073-20601 modeling constructs .15
4.3 Compliance with other standards .16
5. Thermometer device concepts and modalities .16
5.1 General .16
5.2 Body temperature .17
6. Thermometer domain information model .17
6.1 Overview .17
6.2 Class extensions .17
6.3 Object instance diagram .17
6.4 Types of configuration .18
6.5 Medical device system object .19
6.6 Numeric objects .23
6.7 Real-time sample array objects .26
6.8 Enumeration objects .26
6.9 PM store objects .26
6.10 Scanner objects .26
6.11 Class extension objects .26
6.12 Thermometer information model extensibility rules .26
7. Thermometer service model .27
7.1 General .27
7.2 Object access services .27
7.3 Object access event report services .29
8. Thermometer communication model .29
8.1 Overview .29
8.2 Communications characteristics .29
8.3 Association procedure.30
8.4 Configuring procedure .31
8.5 Operating procedure .33
8.6 Time synchronization .34
9. Test associations .34
9.1 General .34
9.2 Behavior with standard configuration .34
9.3 Behavior with extended configurations .34
10. Conformance .34
10.1 Applicability .34
10.2 Conformance specification .35
10.3 Levels of conformance .35
10.4 Implementation conformance statements .36
Annex A (informative) Bibliography .41
Annex B (normative) Any additional ASN.1 definitions .42
Annex C (normative) Allocation of identifiers .43
Annex D (informative) Message sequence examples .44
Annex E (informative) Protocol data unit examples .46
Annex F (informative) Revision history .54

Health informatics—Personal health device communication
Part 10408: Device specialization—
Thermometer
1. Overview
1.1 Scope
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 thermometers.
1.2 Purpose
This standard addresses a need for an openly defined, independent standard for controlling information
exchange to and from personal health devices and compute engines (e.g., cell phones, personal computers,
personal health appliances, and set top boxes). Interoperability is the key to growing the potential market
for these devices and to enabling people to be better informed participants in the management of their
health.
1.3 Context
See IEEE Std 11073-20601™ for an overview of the environment within which this standard is written.

This document, IEEE Std 11073-10408, defines the device specialization for the thermometer, being a
specific agent type, and it provides a description of the device concepts, its capabilities, and its
implementation according to this standard.

This standard is based on IEEE Std 11073-20601, which in turn draws information from both
ISO/IEEE 11073-10201:2004 [B6] and ISO/IEEE 11073-20101:2004 [B7]. The medical device encoding
rules (MDERs) used within this standard are fully described in IEEE Std 11073-20601.

Information on normative references can be found in Clause 2.
The numbers in brackets correspond to the numbers of the bibliography in Annex A.
IEEE Std 11073-10408-2019
Health Informatics—Personal health device communication
Part 10408: Device specialization—Thermometer

This standard defines specialized nomenclature codes that will be collected in future versions of
IEEE Std 11073-10101. Between this standard, IEEE Std 11073-10101, IEEE Std 11073-20601, and
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 that is 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 published as corrigenda.
NOTE—In this standard, the term IEEE Std 11073-104zz is used to refer to the collection of device specialization
standards that utilize IEEE Std 11073-20601, where zz can be any number from 01 to 99, inclusive.
1.4 Word usage
The word shall indicates mandatory requirements strictly to be followed in order to conform to the standard
4,5
and from which no deviation is permitted (shall equals is required to).

The word should indicates that among several possibilities one is recommended as particularly suitable,
without mentioning or excluding others; or that a certain course of action is preferred but not necessarily
required (should equals is recommended that).

The word may is used to indicate a course of action permissible within the limits of the standard (may
equals is permitted to).
The word can is used for statements of possibility and capability, whether material, physical, or causal (can
equals is able to).
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so that each referenced document is cited in text and its relationship to this
document is explained). For dated references, only the edition cited applies. For undated references, the
latest edition of the referenced document (including any amendments or corrigenda) applies.

IEEE Std 11073-20601™, Health informatics—Personal health device communication—Part 20601:
6,7
Application profile—Optimized Exchange Protocol.
IEEE Std 11073-10101™, Health informatics—Point-of-care medical device communication—Part 10101:
Nomenclature.
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
The use of the word must is deprecated and cannot be used when stating mandatory requirements; must is used only to describe
unavoidable situations.
The use of will is deprecated and cannot be used when stating mandatory requirements; will is used only in statements of fact.
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IEEE publications are available from The Institute of Electrical and Electronics Engineers (http://standards.ieee.org/).
IEEE Std 11073-10408-2019
Health Informatics—Personal health device communication
Part 10408: Device specialization—Thermometer

3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this standard, the following terms and definitions apply. The IEEE Standards
Dictionary Online should be referenced for terms not defined in this clause.

agent: A node that collects and transmits personal health data to an associated manager.

body temperature: The measurement of the core body temperature of the person.

class: In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated
from the class utilize.
compute engine: See: manager.
device: A physical device implementing either an agent or a manager role.

extremity body temperature: The measurement of the temperature at the extremities of the body of the
person, such as finger or toe.

handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances within
an agent.
manager: A node receiving data from one or more agent systems. Examples of managers include a cellular
phone, health appliance, set top box, or a computer system.

obj-handle: See: handle.
object: A unit that represents some functionality or item in a device whose properties are described by
attributes.
personal health device: A device used in personal health applications.

personal telehealth device: See: personal health device.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
DIM domain information model
EUI-64 extended unique identifier (64 bits)
ICS implementation conformance statement
MDC medical device communication
MDER medical device encoding rules
MDS medical device system
MOC managed object class
PDU protocol data unit
PHD personal health device
RT-SA real-time sample array
VMO virtual medical object
VMS virtual medical system
IEEE Standards Dictionary Online is available at http://dictionary.ieee.org.
IEEE Std 11073-10408-2019
Health Informatics—Personal health device communication
Part 10408: Device specialization—Thermometer

4. Introduction to ISO/IEEE 11073 personal health devices
4.1 General
This standard and the remainder of the series of ISO/IEEE 11073 personal health device (PHD) standards
fit in the larger context of the ISO/IEEE 11073 series of standards. The full suite of standards enables
agents to interconnect and interoperate with managers and with computerized health-care information
systems. See IEEE Std 11073-20601 for a description of the guiding principles for this series of
ISO/IEEE 11073 personal health device standards.

IEEE Std 11073-20601 supports the modeling and implementation of an extensive set of personal health
devices. This standard defines aspects of the thermometer device. It describes all aspects necessary to
implement the application layer services and data exchange protocol between an ISO/IEEE 11073 PHD
thermometer agent and a manager. This standard utilizes a subset of the classes and functionality defined in
IEEE Std 11073-20601, defines the objects needed to model a thermometer, and adds new modeling
definitions where appropriate. All new definitions are given in Annex B in Abstract Syntax Notation One
(ASN.1) [B8].
All nomenclature codes referenced in this standard are collected in Annex C. Annex C may contain
definitions of codes that are used by this standard and that are not yet present in the referenced versions of
IEEE Std 11073-10101 and IEEE Std 11073-20601.
4.2 Introduction to IEEE 11073-20601 modeling constructs
4.2.1 General
The ISO/IEEE 11073 series of standards, and in particular IEEE Std 11073-20601, is based on an object-
oriented systems management paradigm. The overall s
...