EN ISO 11073-10420:2012
(Main)Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012)
Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012)
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.
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10420: Gerätespezifikation - Analysegerät für die Zusammensetzung des Körpers (ISO/IEEE 11073-10420:2012)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10420: Spécialisation de dispositif - Analyseur de composition corporelle (ISO 11073-10420:2012)
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.
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10420. del: Specialne naprave - Analizator telesne sestave (ISO 11073-10420:2012)
Ta standard v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 določa normativno opredelitev komunikacije med osebnimi napravami za analizo telesne sestave in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play. Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073 in informacijskimi modeli iz standarda IEEE 11073-20601™-20081. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih ter v korist interoperabilnosti omejuje opcionalnost osnovnih okvirov. Ta standard določa skupno jedro komunikacijske funkcionalnosti za osebne telemedicinske naprave za analizo telesne sestave. Naprave za analizo telesne sestave v tem okviru opisujejo naprave za analizo telesne sestave, ki merijo impedanco telesa in na njeni podlagi izračunajo različne telesne komponente, vključno s telesno maščobo.
General Information
- Status
- Withdrawn
- Publication Date
- 31-Oct-2012
- Withdrawal Date
- 20-Jan-2026
- Technical Committee
- CEN/TC 251 - Medical informatics
- Drafting Committee
- CEN/TC 251/WG 2 - Terminology and knowledge representation
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 21-Dec-2022
- Completion Date
- 28-Jan-2026
Relations
- Effective Date
- 23-Mar-2022
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Frequently Asked Questions
EN ISO 11073-10420:2012 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012)". This standard covers: 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.
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.
EN ISO 11073-10420:2012 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment; 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 11073-10420:2012 has the following relationships with other standards: It is inter standard links to EN ISO/IEEE 11073-10420:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 11073-10420:2012 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2013
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10420. del:
Specialne naprave - Analizator telesne sestave (ISO 11073-10420:2012)
Health informatics - Personal health device communication - Part 10420: Device
specialization - Body composition analyzer (ISO 11073-10420:2012)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10420: Spécialisation de dispositif - Analyseur de la composition du corps (ISO 11073-
10420:2012)
Ta slovenski standard je istoveten z: EN ISO 11073-10420:2012
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD 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.
EUROPEAN STANDARD
EN ISO 11073-10420
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 10420: Device specialization - Body composition analyzer
(ISO 11073-10420:2012)
Informatique de santé - Communication entre dispositifs de
santé personnels - Partie 10420: Spécialisation de
dispositif - Analyseur de composition corporelle (ISO
11073-10420:2012)
This European Standard was approved by CEN on 20 October 2012.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10420:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11073-10420:2012) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11073-10420:2012 has been approved by CEN as a EN ISO 11073-10420:2012 without any
modification.
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
ISO/IEEE 11073-10420:2012(E)
© 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
address below.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc.
Case postale 56 CH-1211 Geneva 20 3 Park Avenue, New York NY 10016-5997, USA
Tel. + 41 22 749 01 11 E-mail stds.ipr@ieee.org
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © IEEE 2012 – All rights reserved
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
© IEEE 2012 – All rights reserved iii
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
iv © IEEE 2012 – All rights reserved
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
© IEEE 2012 – All rights reserved v
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
vi © IEEE 2012 – All rights reserved
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.
© IEEE 2012 – All rights reserved vii
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
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.
Information on references can be found in Clause 2.
© IEEE 2012 – All rights reserved
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
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
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.
The numbers in brackets correspond to those of the bibliography in Annex A.
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
IEEE publications are available from the Institute of Electrical and Electronics Engineers, Inc., 445 Hoes Lane, Piscataway, NJ
08854, USA (http://standards.ieee.org/).
The IEEE standards or products referred to in this clause are trademarks of the Institute of Electrical and Electronics Engineers, Inc.
© IEEE 2012 – All rights reserved
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
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.
The IEEE Standards Dictionary: Glossary of Terms & Definitions is available at http://shop.ieee.org/.
© IEEE 2012 – All rights reserved
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.
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10420:2012(E)
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 implement any combination of the optional
elements. A manager implementing this standard shall utilize at least one of the mandatory, conditional,
recommended, or optional elements. In this context, “utilize” means to use the element as part of the
primary function of the manager device. For example, a manager whose primary function is to display data
would need to display a piece of data in the element in order to utilize it.
5 Body composition analyzer device concepts and modalities
5.1 General
This clause presents the general concepts of body composition analyzer devices. In the context of personal
health devices in this family of standards, a body composition analyzer is a device that analyzes the
constituents of the human body. Body composition analyzer devices may use a variety of techniques for
measuring body composition. One typical method is body impedance analysis that measures the impedance
with pairs of probes applied at the feet and/or hands and calculates the body composition from these
impedances.
In the personal health context, the body composition of a person is typically not measured more frequently
than once a day.
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10420:2012(E)
5.2 Body fat
Body fat is a measure of the obesity of a person. It has measurement units of kilograms (kg), pounds (lb) or
percentage (%). The body fat percent is defined as the individual’s body fat in kilograms divided by the
individual’s weight in kilograms as shown in Equation (1).
body fat []kg
Body fat (%) = ×100
body weight [kg]
(1)
The normal range of body fat is 10–20% for men and 18–28 % for women, with the standard value of 15%
and 2%, respectively.
5.3 Body height
Refer to 5.3 of IEEE Std 11073-10415-2008. In this standard, body height is required to compute the body
composition of a person. It is measured by the device or entered manually.
5.4 Body weight
Refer to 5.2 of IEEE Std 11073-10415-2008. In this standard, body weight is required to compute the body
composition of a person. It is measured by the device or entered manually.
5.5 Body mass index
Refer to 5.4 of IEEE Std 11073-10415-2008.
5.6 Fat free mass
The fat free mass (FFM) is the sum of the soft lean mass (SLM) and the mineral mass. It has units of
kilograms (kg) or pounds (lb).
5.7 Soft lean mass
The SLM is the sum of the body water and the protein mass. It has units of kilograms (kg) or pounds (lb).
5.8 Body water
Body water accounts for the largest portion of body composition, being about 50–70% of body weight. It
has units of kilograms (kg), pounds (lb), or percentage (%). The body water percent is defined as the
individual’s body water in kilograms divided by the individual’s weight as shown in Equation (2).
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10420:2012(E)
body water []kg
Body water (%) = ×100
body weight [kg]
(2)
6 Body composition analyzer domain information model
6.1 Overview
This clause describes the domain information model of the body composition analyzer.
6.2 Class extensions
In this standard, no class extensions are defined with respect to IEEE Std 11073-20601-2008.
6.3 Object instance diagram
The object instance diagram of the body composition analyzer domain information model, defined for the
purposes of this standard, is shown in Figure 1.
The objects of the DIM, as shown in Figure 1, are described in 6.5 to 6.10. This includes the medical
device system (MDS) object (see 6.5), the numeric objects (see 6.6), the RT-SA objects (see 6.7), the
enumeration objects (see 6.8), the PM-store objects (see 6.9), and the scanner objects (see 6.10). See 6.11
for rules for extending the body composition analyzer information model beyond elements as described in
this standard. Each clause that describes an object of the body composition analyzer contains the following
information:
⎯ The nomenclature code used to identify the class of the object. One example where this code is
used is the configuration event, where the object class is reported for each object. This allows the
manager to determine whether the class of the object being specified is a numeric, real time
sample array, enumeration, scanner, or PM-store class.
⎯ The attributes of the object. Each object has attributes that represent and convey information on
the physical device and its data sources. Each object has a Handle attribute that identifies the
object instance within an agent. Attribute values are accessed and modified using methods such as
GET and SET. Attribute types are defined using ASN.1 [B4]. The ASN.1 definitions for new
attribute types specific to this standard are in Annex B, and the ASN.1 definitions for existing
attribute types referenced in this standard are in IEEE Std 11073-20601-2008.
⎯ The methods available on the object.
⎯ The potential events generated by the object. Data are sent to the manager using events.
⎯ The available services such as getting or setting attributes.
The attributes for each class are defined in tables that specify the name of the attribute, its value, and its
qualifier. The qualifiers mean: M—Attribute is Mandatory, C—Attribute is Conditional and depends on the
condition stated in the Remark or Value column (if IEEE Std 11073-20601-2008 is referenced, then it
contains the conditions), R—Attribute is Recommended, NR—Attribute is Not Recommended, O—
Attribute is Optional. Mandatory attributes shall be implemented by an agent. Conditional attributes shall
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10420:2012(E)
be implemented if the condition applies and may be implemented otherwise. Recommended attributes
should be implemented by the agent. Not recommended attributes should not be implemented by the agent.
Optional attributes may be implemented by the agent.
The attributes can be either static, meaning that they shall remain unchanged after the configuration is
agreed upon, or dynamic, meaning that the attribute may change at some point after configuration.
Class PHD-Body Composition Analyzer object instances
MDS
MDS
Weighing Scale
Body composition analyzer
Numeric
0.1 Fat Free Mass
1 1
Numeric
Body fat
1.2
Numeric
0.1 Soft Lean Mass
Numeric
Body height
Numeric
0.2 Body Water
Numeric
Body weight
Numeric
0.1 Body mass index
Figure 1 —Body composition analyzer—domain information model
6.4 Types of configuration
6.4.1 General
As specified in IEEE Std 11073-20601-2008, there are two styles of configuration available. Subclauses
6.4.2 and 6.4.3 briefly introduce standard and extended configurations.
6.4.2 Standard configuration
Standard configurations are defined in the IEEE Std 11073-104zz specializations (such as this standard)
and are assigned a well-known identifier (Dev-Configuration-Id). The usage of a standard configuration is
negotiated at association time between the agent and manager. If the manager recognizes and selects to
operate using the configuration, then the agent can send measurements immediately. If the manager does
not recognize the configuration, the agent provides the configuration prior to transmitting measurement
information.
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10420:2012(E)
6.4.3 Extended configuration
In extended configurations, the agent’s configuration is not predefined in a standard. The agent determines
the objects, attributes, and values that will be used in a configuration and assigns a configuration identifier.
When the agent associates with a manager, an acceptable configuration is negotiated. Typically, the
manager does not recognize the agent’s configuration on the first connection, so the manager responds that
the agent needs to send its configuration information as a configuration event report. If, however, the
manager recognizes the configuration, either because it was preloaded in some way or the agent had
previously associated with the manager, then the manager responds that the configuration is known and no
further configuration information needs to be sent.
6.5 Medical device system object
6.5.1 MDS object attributes
Table 1 summarizes the attributes of the body composition analyzer MDS object. The nomenclature code to
identify the MDS class is MDC_MOC_VMS_MDS_SIMP.
Table 1 —MDS object attributes
Attribute name Value Qual.
Handle 0 M
System-Type Attribute not present. See IEEE Std 11073-20601-2008 C
System-Type-Spec-List {MDC_DEV_SPEC_PROFILE_BCA, 1} M
System-Model {“Manufacturer”, “Model”} M
System-Id Extended unique identifier (64-bits) (EUI-64) M
Dev-Configuration-Id Standard config: 0x07D0 (2000) M
Extended configs: 0x4000-0x7FFF
Attribute-Value-Map See IEEE Std 11073-20601-2008 C
Production-Specification See IEEE Std 11073-20601-2008 O
Mds-Time-Info See IEEE Std 11073-20601-2008 C
Date-and-Time See IEEE Std 11073-20601-2008 C
Relative-Time See IEEE Std 11073-20601-2008 C
HiRes-Relative-Tim
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