ISO/IEEE 11073-10422:2017

INTERNATIONAL ISO/IEEE
STANDARD 11073-10422
First edition
2017-10
Health informatics — Personal health
device communication —
Part 10422:
Device specialization — Urine
analyser
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10422: Specialisation des dispositifs — Analyseur d’urine
Reference number
©
IEEE 2016
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ISO/IEEE 11073-10422 was prepared by the 11073 Committee of the Engineering in Medicine and Biology
Society of the IEEE (as IEEE Std 11073-10422-2016). It was adopted by Technical Committee ISO/TC 215,
Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track procedure”
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© IEEE 201 6 iii
– All rights reserved
IEEE Std 11073-10422™-2016
Health informatics—Personal health device communication
Part 10422: Device Specialization—
Urine Analyzer
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 30 June 2016
IEEE-SA Standards Board
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication,
a normative definition of communication between personal telehealth urine analyzer devices and
compute engines (e.g., cell phones, personal computers, personal health appliances, and set-top
boxes) is established by this standard 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 in telehealth environments restricting optionality in base frameworks
in favor of interoperability is specified. A common core of communication functionality for personal
telehealth urine analyzers is defined in this standard.
TM
Keywords: IEEE 11073-10422 , medical device communication, personal health devices, urine
analyzer
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Participants
At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Personal Health
Devices Working Group had the following membership:
Daidi Zhong, Co-Chair
Michael J. Kirwan, Co-Chair
Sungkee Lee, Vice Chair
Karsten Aalders Santiago Carot-Nemesio Christoph Fischer
Randy W. Carroll Morten Flintrup
Charles R. Abbruscato
Nabil Abujbara Simon Carter Joseph W. Forler
Maher Abuzaid Seungchul Chae Russell Foster
Eric Freudenthal
James Agnew Rahul Chauhan
Haidar Ahmad James Cheng Matthias Frohner
Manfred Aigner Peggy Chien Ken Fuchs
Jorge Alberola David Chiu Jing Gao
Murtaza Ali Jinyong Choi Xuemei Gao
Rolf Ambuehl Chia-Chin Chong Marcus Garbe
David Aparisi Saeed A. Choudhary John Garguilo
Paolo Ariano Jinhan Chung Rick Geimer
Lawrence Arne Malcolm Clarke Igor Gejdos
Diego B. Arquillo John A. Cogan Ferenc Gerbovics
John T. Collins Nicolae Goga
Serafin Arroyo
Muhammad Asim Cory Condek Julian Goldman
Merat Bagha Todd H. Cooper Raul Gonzalez Gomez
Chris Gough
Doug Baird David Cornejo
David Baker Douglas Coup Channa Gowda
Anindya Bakshi Nigel Cox Charles M. Gropper
Ananth Hans Crommenacker Amit Gupta
Balasubramanian Tomio Crosley Jeff Guttmacher
Sunlee Bang Allen Curtis Rasmus Haahr
M. Jonathan Barkley Ndifor Cyril Fru Christian Habermann
Jesús Daniel Trigo Michael Hagerty
Gilberto Barrón
David Bean Eyal Dassau Jerry Hahn
John Bell David Davenport Robert Hall
Russell Davis Nathaniel Hamming
Rudy Belliardi
Kathryn M. Bennett Sushil K. Deka Rickey L. Hampton
Daniel Bernstein Ciro de la Vega Sten Hanke
Aki Harma
George A. Bertos Pedro de-las-Heras-
Chris Biernacki Quiros Jordan Hartmann
Ola Björsne Jim DelloStritto Kai Hassing
Thomas Blackadar Matthew d’Entremont Marc Daniel Haunschild
Marc Blanchet Kent Dicks Wolfgang Heck
Thomas Bluethner Hyoungho Do Nathaniel Heintzman
Douglas P. Bogia Alistair Donaldson Charles Henderson
Xiaolian Duan Jun-Ho Her
Xavier Boniface
Shannon Boucousis Brian Dubreuil Helen B. Hernandez
Julius Broma Sourav Dutta Takashi Hibino
Jakob Ehrensvard Timothy L. Hirou
Lyle G. Bullock Jr.
Bernard Burg Fredrik Einberg Allen Hobbs
Chris Burns Michihiro Enokida Alex Holland
Arto Holopainen
Anthony Butt Javier Escayola Calvo
Jeremy Byford-Rew Mark Estes Kris Holtzclaw
Satya Calloji Leonardo Estevez Robert Hoy
Xiaoying Cao Roger Feeley Frank Hsu
Carole C. Carey Hailing Feng Anne Huang
Craig Carlson Bosco T. Fernandes Sen-Der Huang
Zhiqiang Huang Charles Lowe Phillip Raymond
Ron Huby Don Ludolph Tim Reilly
Barry Reinhold
David Hughes Christian Luszick
Robert D. Hughes Bob MacWilliams Brian Reinhold
Jiyoung Huh Srikkanth Melvin I. Reynolds
Hugh Hunter Madhurbootheswaran John G. Rhoads
Hitoshi Ikeda Miriam L. Makhlouf Jeffrey S. Robbins
Yutaka Ikeda Romain Marmot Chris Roberts
Philip O. Isaacson Sandra Martinez Moskowitz Robert
Miguel Martínez de Timothy Robertson
Atsushi Ito
Michael Jaffe Espronceda Cámara David Rosales
Praduman Jain Peter Mayhew Fatemeh Saki
Jim McCain Bill Saltzstein
Wei Jin
Danny Jochelson László Meleg Benedikt Salzbrunn
Phaneeth Junga Alexander Mense Giovanna Sannino
Jose A. Santos-Cadenas
Akiyoshi Kabe Jinsei Miyazaki
Steve Kahle Erik Moll Stefan Sauermann
Tomio Kamioka Darr Moore John Sawyer
Kei Kariya Carsten Mueglitz Guillaume Schatz
Andy Kaschl Piotr Murawski Alois Schloegl
Junzo Kashihara Soundharya Paul S. Schluter
Kohichi Kashiwagi Nagasubramanian Lars Schmitt
Jae-Wook Nah Mark G. Schnell
Ralph Kent
Laurie M. Kermes Alex Neefus Richard A. Schrenker
Ikuo Keshi Trong-Nghia Nguyen- Antonio Scorpiniti
Dobinsky Kwang Seok Seo
Junhyung Kim
Minho Kim Michael E. Nidd Riccardo Serafi n
Min-Joon Kim Tetsu Nishimura Sid Shaw
Frank Shen
Taekon Kim Jim Niswander
Tetsuya Kimura Hiroaki Niwamoto Bozhi Shi
Michael J. Kirwan Thomas Norgall Min Shih
Alfred Kloos Anand Noubade Mazen Shihabi
Jeongmee Koh Yoshiteru Nozoe Redmond Shouldice
Jean-Marc Koller Abraham Ofek Sternly K. Simon
John Koon Brett Olive Marjorie Skubic
Begonya Otal Robert Smith
Patty Krantz
Raymond Krasinski Marco Paleari Ivan Soh
Alexander Kraus Charles Palmer Motoki Sone
Bud Panjwani Emily Sopensky
Ramesh Krishna
Geoffrey Kruse Carl Pantiskas Rajagopalan Srinivasan
Falko Kuester Harry P. Pappas Andreas Staubert
Nicholas Steblay
Rafael Lajara Hanna Park
Pierre Landau Jong-Tae Park Lars Steubesand
Jaechul Lee Myungeun Park John (Ivo) Stivoric
JongMuk Lee Soojun Park Raymond A. Strickland
Kyong Ho Lee Phillip E. Pash Chandrasekaran
Rami Lee TongBi Pei Subramaniam
Sungkee Lee Lucian Pestritu Hermanni Suominen
Soren Petersen Lee Surprenant
Woojae Lee
Yonghee Lee James Petisce Ravi Swami
Joe Lenart Peter Piction Ray Sweidan
Michael Pliskin Jin Tan
Kathryn A. Lesh
Catherine Li Varshney Prabodh Yi Tang
Qiong Li Jeff Price Haruyuyki Tatsumi
John W. Thomas
Patrick Lichter Harald Prinzhorn
Jisoon Lim Harry Qiu Jonas Tirén
Joon-Ho Lim Arif Rahman Alexandra Todiruta
John Lin Tanzilur Rahman Janet Traub
Wei-Jung Lo Steve Ray Gary Tschautscher
Copyright © 2016 IEEE. All rights reserved.

Masato Tsuchid Jerry P. Wang Yaxi Yan
Ken Tubman Yao Wang Qifeng Yan
Yoshihiro Uchida Yi Wang Junjie Yang
Akib Uddin Steve Warren Ricky Yang
Sunil Unadkat Fujio Watanabe Melanie S. Yeung
Fabio Urbani Toru Watsuji Qiang Yin
Philipp Urbauer Mike Weng Done-Sik Yoo
Laura Vanzago Kathleen Wible Jianchao Zeng
Alpo Värri Paul Williamson Jason Zhang
Zhiqiang Zhang
Dalimar Velez Jan Wittenber
Rudi Voon Jia-Rong Wu Thomas Zhao
Barry Vornbrock Will Wykeham Daidi Zhong
Isobel Walker Ariton Xhafa Miha Zoubek
David Wang Dan Xiao Szymon Zyskoter
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Lars Schmitt
Lyle Bullock Werner Hoelzl
Keith Chow Atsushi Ito Walter Struppler
Malcolm Clarke JongMuk Lee J. Wiley
Randall Groves Melvin Reynolds Jan Wittenber
Jon Hagar Bartien Sayogo Oren Yuen
Kai Hassing Daidi Zhong
When the IEEE-SA Standards Board approved this standard on 30 June 2016, it had the following membership:
Jean-Philippe Faure, Chair
Ted Burse, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Chuck Adams Ronald W. Hotchkiss Mehmet Ulema
Masayuki Ariyoshi Michael Janezic Yingli Wen
Stephen Dukes Joseph L. Koepfi nger* Howard Wolfman
Jianbin Fan Hung Ling Don Wright
J. Travis Griffi th Kevin Lu Yu Yuan
Gary Hoffman Annette D. Reilly Daidi Zhong
Gary Robinson
*Member Emeritus
Copyright © 2016 IEEE. All rights reserved.

Introduction
This introduction is not part of IEEE Std 11073-10422™-2016, Health informatics—Personal health device communi-
cation—Part 10422: Device Specialization—Urine Analyzer.
ISO/IEEE 11073™ standards enable communication between medical devices and external computer sys-
tems. This document uses the optimized framework created in IEEE Std 11073-20601™-2014 and describes a
specific, interoperable communication approach for urine analyzers. These standards align with and draw on
the existing clinically focused standards to provide support for communication of data from clinical or person-
al health devices.
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
2. Normative references . 13
3. Definitions, acronyms, and abbreviations . 13
3.1 Definitions . 13
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. Urine analyzer device concepts and modalities . 16
5.1 General . 16
5.2 Bilirubin . 16
5.3 Blood . 16
5.4 Glucose . 16
5.5 Ketones . 17
5.6 Leukocyte esterase . 17
5.7 Nitrite . 17
5.8 pH . 17
5.9 Protein . 17
5.10 Specific gravity . 17
5.11 Urobilinogen . 17
6. Urine analyzer domain information model . 17
6.1 Overview . 17
6.2 Class extensions . 18
6.3 Object instance diagram . 18
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 . 33
6.8 Enumeration objects . 33
6.9 PM-store objects . 34
6.10 Scanner objects . 34
6.11 Class extension objects . 34
6.12 Urine analyzer information model extensibility rules . 34
7. Urine analyzer service model . 34
7.1 General . 34
7.2 Object access services . 34
7.3 Object access event report services . 36
8. Urine analyzer communication model . 36
8.1 Overview . 36
8.2 Communication characteristics . 36
8.3 Association procedure . 37
8.4 Configuring procedure . 38
8.5 Operating procedure . 38
8.6 Time synchronization . 39
9. Test associations . 39
10. Conformance . 39
10.1 Applicability . 39
10.2 Conformance specification . 39
10.3 Levels of conformance . 39
10.4 Implementation conformance statements . 40
Annex A (informative) Bibliography . 44
Annex B (normative) Any additional ASN.1 definitions . 45
Annex C (normative) Allocation of identifiers . 46
Annex D (informative) Message sequence examples . 48
Annex E (informative) Protocol data unit examples . 50
Health informatics—Personal health device communication
Part 10422: Device Specialization—
Urine Analyzer
1. Overview
1.1 Scope
Within the context of the ISO/IEEE 11073™ family of standards for device communication, this standard
establishes a normative defi nition of communication between personal telehealth urine analyzer devices and
managers (e.g., cell phones, personal computers, personal health appliances, 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 profi le standards, and transport standards. It spec-
ifi es the use of specifi c term codes, formats, and behaviors in telehealth environments restricting optionality
in base frameworks in favor of interoperability. This standard defi nes a common core of communication func-
tionality for personal telehealth urine analyzers.
1.2 Purpose
This standard addresses a need for an openly defi ned, independent standard for controlling information ex-
change to and from personal health devices and compute engines (e.g., cell phones, personal computers, per-
sonal 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™-2014 for an overview of the environment within which this standard is written.
This standard defi nes the device specialization for the urine analyzer, being a specifi c agent type, and it pro-
vides a description of the device concepts, its capabilities, and its implementation according to this standard.
This standard is based on IEEE Std 11073-20601-2014, which in turn draws information from both ISO/IEEE
11073-10201™:2004 [B8] and ISO/IEEE 11073-20101™:2004 [B9]. The medical device encoding rules
(MDER) used within this standard are fully described in IEEE Std 11073-20601-2014.
This standard reproduces relevant portions of the nomenclature found in both ISO/IEEE 11073-10101:2004
[B7] and IEEE Std 11073-10101a™-2015 [B5], and adds new nomenclature codes for the purposes of this
Information on references can be found in Clause 2.
The numbers in brackets correspond to those of the bibliography in Annex A.
Copyright © 2016 IEEE. All rights reserved.

IEEE Std 11073-10422-2016
Health informatics—Personal health device communication—Part 10422: Device Specialization—Urine Analyzer
standard. Between this standard and IEEE Std 11073-20601-2014, all required nomenclature codes for imple-
mentation are documented.
NOTE—In this standard, ISO/IEEE 11073-104zz is used to refer to the collection of device specialization standards that
utilize IEEE Std 11073-20601-2014, where zz can be any number from 01 to 99, inclusive.
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.
ISO/IEEE Std 11073-20601™:2010/Amd 1:2015, Health informatics—Personal health device communica-
5,6
tion—Application profi le—Optimized Exchange Protocol—Amendment 1.
IEEE Std 11073-20601™-2014, Health informatics—Personal health device communication—Application
5, 6
profi le—Optimized Exchange Protocol.
3. Defi nitions, acronyms, and abbreviations
3.1 Defi nitions
For the purposes of this document, the following terms and defi nitions apply. The IEEE Standards Dictionary
Online should be consulted for terms not defi ned in this clause.
agent: A node that collects and transmits personal health data to an associated manager.
bilirubin: An orange-yellow pigment formed in the liver by the breakdown of hemoglobin and excreted in
bile.
blood: Presence of red blood cells in urine that is not visibly apparent.
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 term used to refer to a physical apparatus implementing either an agent or a manager role.
glucose: A type of sugar that gives human body energy.
handle: An unsigned 16-bit number that is locally unique and identifi es one of the object instances within an
agent.
ketones: Water-soluble compounds that are produced as by-products when fatty acids are broken down for
energy in the liver.
leukocyte esterase: Presence of enzyme in white blood cells.
Notes in text, tables, and fi gures are given for information only and do not contain requirements needed to implement the standard.
The IEEE standards or products referred to in this clause are trademarks of the Institute of Electrical and Electronics Engineers, Inc.
IEEE publications are available from the Institute of Electrical and Electronics Engineers (http://standards.ieee.org/).
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Copyright © 2016 IEEE. All rights reserved.

IEEE Std 11073-10422-2016
Health informatics—Personal health device communication—Part 10422: Device Specialization—Urine Analyzer
manager: A node receiving data from one or more agent systems. Some examples of managers include a cel-
lular phone, health appliance, set-top box, or a computer system.
nitrite: Any salt or ester of nitrous acid.
object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes attributes,
methods, and events from the class.
obj-handle: See: handle.
personal health device: A device used in personal health applications.
personal telehealth device: See: personal health device.
pH: A measure of the activity of the hydrogen ion. Essentially, it is a measure of acidity or alkalinity.
protein: A large group of nitrogenous compounds of high molecular weight that are essential constituents of
all living organisms.
specifi c gravity: The ratio of the density of a substance to the density of a reference substance.
urine analyzer: An agent for measuring the amount of chemical substances in urine and some properties of
urine.
urobilinogen: A colorless product of bilirubin reduction.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
DIM domain information model
EUI-64 extended unique identifi er (64 bits)
ICS implementation conformance statement
MDC medical device communication
MDER medical device encoding rules
MDS medical device system
MOC managed object class
OID object identifi er
PDU protocol data unit
PHD personal health device
POC personal device domain information model object and class
VMO virtual medical object
VMS virtual medical system
Copyright © 2016 IEEE. All rights reserved.

IEEE Std 11073-10422-2016
Health informatics—Personal health device communication—Part 10422: Device Specialization—Urine Analyzer
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 in-
terconnect and interoperate with managers and with computerized health-care information systems. See IEEE
Std 11073-20601-2014 for a description of the guiding principles for this series of ISO/IEEE 11073 Personal
Health Device standards.
IEEE Std 11073-20601-2014 supports the modeling and implementation of an extensive set of personal health
devices. This standard defines aspects of the urine analyzer device. It describes all aspects necessary to imple-
ment the application layer services and data-exchange protocol between an ISO/IEEE 11073 PHD urine an-
alyzer agent and a manager. This standard defines a subset of the objects and functionality contained in IEEE
Std 11073-20601-2014, and it extends and adds definitions where appropriate. All new definitions are given
in Annex B in Abstract Syntax Notation One (ASN.1). Nomenclature codes referenced in this standard, which
are not defined in IEEE Std 11073-20601-2014, are normatively defined in Annex C.
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 11073-20601-2014, is based on an ob-
ject-oriented systems management paradigm. The overall system model is divided into three principal compo-
nents: the domain information model (DIM), the service model, and the communication model. See IEEE Std
11073-20601-2014 for a detailed description of the modeling constructs.
4.2.2 Domain information model
The DIM is a hierarchical model that describes an agent as a set of objects. These objects and their attributes
represent the elements that control behavior and report on the status of the agent and the data that an agent can
communicate to a manager. Communication between the agent and the manager is defined by the application
protocol in IEEE Std 11073-20601-2014.
4.2.3 Service model
The service model defines the conceptual mechanisms for the data-exchange services. Such services are
mapped to messages that are exchanged between the agent and the manager. Protocol messages within the
ISO/IEEE 11073 series of standards are defined in ASN.1. The messages defined in IEEE Std 11073-20601-
2014 can coexist with messages defined in other standard application profiles defined in the ISO/IEEE 11073
series of standards.
4.2.4 Communication model
In general, the communication model supports the topology of one or
...