ISO/IEEE 11073-10420:2012

Health informatics — Personal health device communication — Part 10420: Device specialization — Body composition analyzer

Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10420:2012 establishes a normative definition of the communication between personal body composition analyzing 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 and IEEE 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10420:2012 defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance.

Informatique de santé — Communication entre dispositifs de santé personnels — Partie 10420: Spécialisation de dispositif — Analyseur de composition corporelle

Dans le contexte de la famille de Normes ISO/IEEE 11073 relatives à la communication de dispositifs, l'ISO/IEEE 11073-10420:2012 établit une définition normative de la communication entre les dispositifs personnels d'analyse de composition corporelle et des gestionnaires (par exemple, des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé, des boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Elle s'appuie sur les parties appropriées de Normes existantes, y compris la terminologie de l'ISO/IEEE 11073 et les modèles d'informations de l'IEEE 11073-20601. 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. L'ISO/IEEE 11073-10420:2012 définit un noyau commun de fonctionnalités de communication pour les dispositifs personnels de télésanté que sont les analyseurs de composition corporelle. Dans ce contexte, l'expression «dispositifs d'analyse de composition corporelle» est utilisée au sens large pour englober les dispositifs d'analyse de composition corporelle qui mesurent les impédances dans l'organisme et calculent les proportions des divers composants de l'organisme, notamment la masse grasse, à partir de l'impédance.

General Information

• Status: Withdrawn
• Publication Date: 25-Oct-2012
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 2 - Systems and Device Interoperability
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 15-Dec-2022

Relations

• Revised: ISO/IEEE 11073-10420:2022 - Health informatics — Device interoperability — Part 10420: Personal health device communication — Device specialization — Body composition analyzer
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO/IEEE
STANDARD 11073-10420
First edition
2012-11-01


Health informatics — Personal health
device communication —
Part 10420:
Device specialization — Body
composition analyzer
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10420: Spécialisation de dispositif — Analyseur de la
composition du corps




Reference number
ISO/IEEE 11073-10420:2012(E)

©
ISO 2012
©
 IEEE 2012

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ISO/IEEE 11073-10420:2012(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2012
©  IEEE 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
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Published in Switzerland

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ii © IEEE 2012 – All rights reserved

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ISO/IEEE 11073-10420:2012(E)
Contents

1. Overview . 1

1.1 Scope . 1
1.2 Purpose . 2
1.3 Context . 2
2. Normative references. 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 4
4. Introduction to ISO/IEEE 11073 personal health devices . 4
4.1 General . 4
4.2 Introduction to IEEE 11073-20601 modeling constructs . 4
5. Body composition analyzer device concepts and modalities. 5
5.1 General . 5
5.2 Body fat . 6
5.3 Body height . 6
5.4 Body weight. 6
5.5 Body mass index. 6
5.6 Fat free mass. 6
5.7 Soft lean mass. 6
5.8 Body water. 6
6. Body composition analyzer domain information model. 7
6.1 Overview . 7
6.2 Class extensions. 7
6.3 Object instance diagram . 7
6.4 Types of configuration. 8
6.5 Medical device system object. 9
6.6 Numeric objects. 12
6.7 Real-time sample array objects. 19
6.8 Enumeration objects . 19
6.9 PM-store objects. 20
6.10 Scanner objects. 20
6.11 Class extension objects. 20
6.12 Body composition analyzer information model extensibility rules . 20
7. Body composition analyzer service model . 20
7.1 General . 20
7.2 Object access services. 20
7.3 Object access event report services . 21
8. Body composition analyzer communication model. 22
8.1 Overview . 22
8.2 Communications characteristics . 22
8.3 Association procedure . 22
8.4 Configuring procedure. 24
8.5 Operating procedure . 26
8.6 Time synchronization . 27
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ISO/IEEE 11073-10420:2012(E)

9. Test associations. 27
9.1 Behavior with standard configuration. 27
9.2 Behavior with extended configurations . 28
10. Conformance . 28
10.1 Applicability . 28
10.2 Conformance specification . 28
10.3 Levels of conformance . 28
10.4 Implementation conformance statements . 29
Annex A (informative) Bibliography . 34
Annex B (normative) Any additional ASN.1 definitions . 35
Annex C (normative) Allocation of identifiers. 36
Annex D (informative) Message sequence examples. 37
Annex E (informative) Protocol data unit examples . 39
E.1 General. 39
E.2 Association information exchange . 39
E.3 Configuration information exchange. 42
E.4 GET MDS attributes service . 47
E.5 Data reporting. 48
E.6 Disassociation . 49

Annex F (informative) IEEE list of particpants . 51
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ISO/IEEE 11073-10420:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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 information or the soundness
of any judgments contained in its standards.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential
patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if
any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-10420 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10420-2010). 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” defined in the Partner Standards Development Organization cooperation agreement between ISO
and IEEE. IEEE is responsible for the maintenance of this document with participation and input from ISO
member bodies.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health
device communication (text in parentheses gives a variant of subtitle):
 Part 10101: (Point-of-care medical device communication) Nomenclature
 Part 10201: (Point-of-care medical device communication) Domain information model
 Part 10404: Device specialization — Pulse oximeter
 Part 10407: Device specialization — Blood pressure monitor
 Part 10408: Device specialization — Thermometer
 Part 10415: Device specialization — Weighing scale
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ISO/IEEE 11073-10420:2012(E)
 Part 10417: Device specialization — Glucose meter
 Part 10420: Device specialization — Body composition analyzer
 Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
 Part 10471: Device specialization — Independant living activity hub
 Part 10472: Device specialization — Medication monitor
 Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
 Part 20601: Application profile — Optimized exchange protocol
 Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
 Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
 Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
 Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
 Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
 Part 92001: (Medical waveform format) — Encoding rules

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ISO/IEEE 11073-10420:2012(E)

Introduction
This introduction is not part of IEEE Std 11073-10420-2010, Health Informatics—Personal health device
communication— Part 10420: Device specialization—Body composition analyzer.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
systems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this
standard establishes a normative definition of the communication between medication monitoring 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 and information models. It specifies the use of specific term codes, formats,
and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of
interoperability. This standard defines a common core of communication functionality for personal
telehealth body composition analyzer devices. In this context, body composition analyzer devices are being
used broadly to cover body composition analyzer devices that measure body impedances, and compute the
various body components including body fat from the impedance.
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ISO/IEEE 11073-10420:2012(E)
Health informatics — Personal health device
communication —
Part 10420:
Device specialization — Body composition analyzer

IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or
environmental protection. Implementers of the standard are responsible for determining appropriate
safety, security, environmental, and health practices or regulatory requirements.
This IEEE document is made available for use subject to important notices and legal disclaimers.
These notices and disclaimers appear in all publications containing this document and may
be found under the heading “Important Notice” or “Important Notices and Disclaimers
Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at
http://standards.ieee.org/IPR/disclaimers.html.
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 the communication between personal body composition analyzing
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
1
including ISO/IEEE 11073 terminology and IEEE Std 11073-20601™-2008 information models. 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 body composition analyzer devices. In this context,
body composition analyzer devices are being used broadly to cover body composition analyzer devices that
measure body impedances, and compute the various body components including body fat from the
impedance.

1
Information on references can be found in Clause 2.
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ISO/IEEE 11073-10420:2012(E)
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 managers (e.g., cell phones, personal computers,
personal health appliances, set top boxes). Interoperability is key to growing the potential market for these
devices and enabling people to be better informed participants in the management of their health.
1.3 Context
See IEEE Std 11073-20601-2008 for an overview of the environment within which this standard is written.

This standard defines the device specialization for the body composition analyzer, 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 11073-20601-2008, which in turn draws information from both
2
ISO/IEEE 11073-10201:2004 [B2] and ISO/IEEE 11073-20101:2004 [B3]. The medical device encoding
rules (MDER) used within this standard are fully described in IEEE Std 11073-20601-2008.

This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B1]
and adds new nomenclature codes for the purposes of this standard. Between this standard and IEEE Std
11073-20601-2008 all required nomenclature codes for implementation are documented.

NOTE—In this standard, IEEE Std 11073-104zz is used to refer to the collection of device specialization standards that
3
utilize IEEE Std 11073-20601-2008, 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.
IEEE Std 11073-20601-2008, Health informatics—Personal health device communication—Part 20601:
4, 5
Application Profile—Optimized Exchange Profile.
IEEE Std 11073-10415™-2008, Health informatics—Personal health device communication—Part 10415:
Device specialization—Weighing scale.
See Annex A for all informative material referenced by this standard.



2
The numbers in brackets correspond to those of the bibliography in Annex A.
3
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
4
IEEE publications are available from the Institute of Electrical and Electronics Engineers, Inc., 445 Hoes Lane, Piscataway, NJ
08854, USA (http://standards.ieee.org/).
5
The IEEE standards or products referred to in this clause are trademarks of the Institute of Electrical and Electronics Engineers, Inc.

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ISO/IEEE 11073-10420:2012(E)

3 Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this document, the following terms and definitions apply. The IEEE Standards
6
Dictionary: Glossary of Terms & Definitions 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 composition analyzer: An agent for measuring the fundamental constituents of the human body that
consists of water, protein, mineral, and fat.
body fat: The difference between the body weight and the fat free mass.
body water: The total water of the human body.
body weight: The sum of the body water mass, protein mass, mineral mass, and the body fat mass.
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.
fat free mass: The sum of the soft lean mass and mineral mass.
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. Some examples of managers include a
cellular phone, health appliance, set top box, or a computer system.
mass: An intrinsic property of matter that can be measured using the effect of the gravitational field on an
object.
obj-handle: See: handle.
object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
personal health device: A device used in personal health applications.
personal telehealth device: See: personal health device.
soft lean mass: The sum of the body water mass and protein mass.
weight: The force that results from the exertion of gravity on an object. The weight is directly proportional
to the mass of the object. However, in the health care domain the term body weight is typically used to denote
the body mass of a person. This notation applies also to this standard.

6
The IEEE Standards Dictionary: Glossary of Terms & Definitions is available at http://shop.ieee.org/.
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ISO/IEEE 11073-10420:2012(E)
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)
FFM fat free mass
ICS implementation conformance statements
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
SLM soft lean mass
VMO virtual medical object
VMS virtual medical system
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 healthcare information
systems. See the IEEE Std 11073-20601-2008 for a description of the guiding principles for this series of
ISO/IEEE 11073 Personal Health Device standards.
IEEE Std 11073-20601-2008 supports the modeling and implementation of an extensive set of personal
health devices. This standard defines aspects of the body composition analyzer device. It describes all
aspects necessary to implement the application layer services and data exchange protocol between an
ISO/IEEE 11073 PHD body composition analyzer agent and a manager. This standard defines a sub-set of
the objects and functionality contained in IEEE Std 11073-20601-2008, and extends and adds definitions
where appropriate. The Abstract Syntax Notation One (ASN.1) [B4] definitions referenced in this standard
are in IEEE Std 11073-20601-2008. All additional new definitions are given in Annex B. Nomenclature
codes referenced in this standard, which are not defined in IEEE Std 11073-20601-2008, 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 11073-20601-2008, is based on an
object-oriented systems management paradigm. The overall system model is divided into three principal
components: the domain information model (DIM), the service model, and the communication model. See
IEEE Std 11073-20601-2008 for a detailed description of the modeling constructs.
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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 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 11073-20601-2008.
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 [B4]. The messages defined in IEEE Std 11073-
20601-2008 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 more agents communicating over
logical point-to-point connections to a single manager. For each logical point-to-point connection, the
dynamic system behavior is defined by a connection state machine as specified in IEEE Std 11073-20601-
2008. The security of this communication is largely determined by, but not limited to, the physical security
of the device along with the inherent security of the underlying transports. Additional security may be
defined by future revisions of IEEE Std 11073-20601-2008.
4.2.5 Implementing the models
An agent implementing this standard shall implement all mandatory elements of the information, service,
and communication models as well as all conditional elements where the condition is met. The agent
should implement the recommended elements, and it may imp
...