ISO/IEEE 11073-10415:2010
(Main)Health informatics - Personal health device communication - Part 10415: Device specialization - Weighing scale
Health informatics - Personal health device communication - Part 10415: Device specialization - Weighing scale
ISO/IEEE 11073-10415:2010 establishes a normative definition of communication between personal telehealth weighing scale devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth weighing scales. ISO/IEEE 11073-10415:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
Informatique de santé — Communication entre dispositifs de santé personnels — Partie 10415: Spécialisation des dispositifs — Plateau de balance
L'ISO/IEEE 11073-10415:2010 établit une définition normative de la communication entre des dispositifs de balances personnelles de télésanté et des moteurs informatiques (par exemple des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et 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, des modèles d'informations, des normes de profils d'applications et des normes de transport de l'ISO/IEEE 11073. 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. Elle définit un noyau commun de fonctionnalités de communication pour les balances personnelles de télésanté. L'ISO/IEEE 11073-10415:2010 répond au besoin d'une norme indépendante définie de manière ouverte portant sur la commande de l'échange d'informations entre des dispositifs personnels de santé et des moteurs informatiques.
General Information
Relations
Frequently Asked Questions
ISO/IEEE 11073-10415:2010 is a standard published by the International Organization for Standardization (ISO). Its full title is "Health informatics - Personal health device communication - Part 10415: Device specialization - Weighing scale". This standard covers: ISO/IEEE 11073-10415:2010 establishes a normative definition of communication between personal telehealth weighing scale devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth weighing scales. ISO/IEEE 11073-10415:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
ISO/IEEE 11073-10415:2010 establishes a normative definition of communication between personal telehealth weighing scale devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth weighing scales. ISO/IEEE 11073-10415:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
ISO/IEEE 11073-10415:2010 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/IEEE 11073-10415:2010 has the following relationships with other standards: It is inter standard links to ISO/IEC TR 15067-4:2001, ISO/IEEE 11073-10415:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO/IEEE 11073-10415:2010 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
INTERNATIONAL ISO/IEEE
STANDARD 11073-10415
First edition
2010-05-01
Health informatics — Point-of-care
medical device communication —
Part 10415:
Device specialization — Weighing scale
Informatique de santé — Communication entre dispositifs médicaux
sur le site des soins —
Partie 10415: Spécialisation des dispositifs — Plateau de balance
Reference number
©
ISO 2010
©
IEEE 2010
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ii © IEEE 2010 – All rights reserved
Contents Page
Foreword. v
Introduction.vii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations. 2
3.1 Definitions. 2
3.2 Acronyms and abbreviations. 3
4. Introduction to ISO/IEEE 11073 personal health devices. 3
4.1 General. 3
4.2 Introduction to IEEE 11073-20601 modeling constructs. 4
5. Weighing scale device concepts and modalities . 4
5.1 General. 4
5.2 Body weight . 5
5.3 Body height. 5
5.4 Body mass index . 5
6. Weighing scale domain information model . 5
6.1 Overview. 5
6.2 Class extensions . 5
6.3 Object instance diagram. 6
6.4 Types of configuration . 7
6.5 Medical device system object . 8
6.6 Numeric objects . 11
6.7 Real-time sample array objects . 15
6.8 Enumeration objects. 15
6.9 PM-store objects . 15
6.10 Scanner objects . 15
6.11 Class extension objects . 15
6.12 Weighing scale information model extensibility rules. 15
7. Weighing scale service model. 15
7.1 General. 15
7.2 Object access services. 15
7.3 Object access event report services. 17
© IEEE 2010 – All rights reserved iii
8. Weighing scale communication model . 17
8.1 Overview. 17
8.2 Communications characteristics. 17
8.3 Association procedure. 18
8.4 Configuring procedure . 19
8.5 Operating procedure. 21
8.6 Time synchronization. 21
9. Test associations . 21
9.1 Behavior with standard configuration . 22
9.2 Behavior with extended configurations. 22
10. Conformance. 22
10.1 Applicability. 22
10.2 Conformance specification. 22
10.3 Levels of conformance. 23
10.4 Implementation conformance statements. 23
Annex A (informative) Bibliography. 28
Annex B (normative) Any additional ASN.1 definitions. 29
Annex C (normative) Allocation of identifiers . 30
Annex D (informative) Message sequence examples . 31
Annex E (informative) Protocol data unit examples. 33
iv © IEEE 2010 – All rights reserved
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
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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
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establishes rules to promote fairness in the consensus development process, the IEEE does not
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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
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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 11073-10415 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-10415-2008). 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. Both parties are responsible for the
maintenance of this document.
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: Domain information model
— Part 10404: Device specialization — Pulse oximeter
© IEEE 2010 – All rights reserved v
— Part 10407: Device specialization — Blood pressure monitor
— Part 10408: (Point-of-care medical device communication) Device specialization —
Thermometer
— Part 10415: (Point-of-care medical device communication) Device specialization — Weighing
scale
— Part 10417: Device specialization — Glucose meter
— Part 10471: (Point-of-care medical device communication) Device specialization —
Independant living activity hub
— Part 20101: (Point-of-care medical device communication) Application profiles — Base
standard
— Part 20601: (Point-of-care medical device communication) 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
vi © IEEE 2010 – All rights reserved
Introduction
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This
a
document uses the optimized framework created in IEEE Std 11073-20601 and describes a specific, interoperable
communication approach for weighing scales. These standards align with, and draw upon, the existing clinically
focused standards to provide support for communication of data from clinical or personal health devices.
a
For information on references, see Clause 2.
© IEEE 2010 – All rights reserved vii
INTERNATIONAL STANDARD ISO/IEEE 11073-10415:2010(E)
Health informatics — Point-of-care medical device
communication —
Part 10415:
Device specialization — Weighing scale
IMPORTANT NOTICE: This standard is not intended to assure safety, security, health, or
environmental protection in all circumstances. 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 communication between personal telehealth weighing scale 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 weighing scales.
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.
© IEEE 2010 – All rights reserved
1.3 Context
TM
See IEEE Std 11073-20601 for an overview of the environment within which this standard is written.
This document, IEEE Std 11073-10415, defines the device specialization for the weighing scale, 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 [B4] and ISO/IEEE 11073-20101:2004 [B5]. The medical device encoding
rules (MDER) used within this standard are fully described in IEEE Std 11073-20601.
This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B3]
and adds new nomenclature codes for the purposes of this standard. Between this standard and
IEEE Std 11073-20601, 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, 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.
TM
IEEE Std 11073-20601 -2008, Health informatics—Personal health device communication—Part 20601:
3, 4
Application profile—Optimized Exchange Protocol.
See Annex A for all informative material referenced by this standard.
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this standard, the following terms and definitions apply. The Authoritative Dictionary of
IEEE Standards [B2] should be referenced for terms not defined in this clause.
3.1.1. agent: A node that collects and transmits personal health data to an associated manager.
3.1.2. class: In object-oriented modeling, it describes the attributes, methods, and events that objects
instantiated from the class utilize.
3.1.3. compute engine: See: manager.
3.1.4. device: A term used to refer to a physical apparatus implementing either an agent or a manager role.
3.1.5. handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances
within an agent.
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.
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, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
© IEEE 2010 – All rights reserved
3.1.6. 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.
3.1.7. mass: An intrinsic property of matter that can be measured using the effect of the gravitational field
on an object.
3.1.8. obj-handle: See: handle.
3.1.9. object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
3.1.10. personal health device: A device used in personal health applications.
3.1.11. personal telehealth device: See: personal health device.
3.1.12. 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.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
BMI body mass index
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
PHD personal health device
RT-SA real-time sample array
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 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 weighing scale device. It describes all aspects necessary to
implement the application layer services and data exchange protocol between an ISO/IEEE 11073 PHD
weighing scale agent and a manager. This standard defines a subset of the objects and functionality
contained in IEEE Std 11073-20601 and extends and adds definitions where appropriate. All new
definitions are given in Annex B in Abstract Syntax Notation One (ASN.1) [B6]. Nomenclature codes
referenced in this standard, which are not defined in ISO/IEEE 11073-20601, are normatively defined in
Annex C.
© IEEE 2010 – All rights reserved
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 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 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 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.
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
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.
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. Weighing scale device concepts and modalities
5.1 General
This clause presents the general concepts of weighing scale devices. In the context of personal health
devices in this family of standards, a weighing scale is a device that measures the body weight of a person
and, optionally, determines other physiological quantities (e.g., the body mass index or the height of a
person). Weighing scale devices considered in this standard are typically placed on the floor with a person
stepping on the device to perform a weight measurement, with the result being converted into mass
internally of the device.
© IEEE 2010 – All rights reserved
In the personal health context, the body weight of a person is typically not measured more frequently than
twice a day.
Weighing scale devices may use a variety of techniques for measuring body weight. One typical method is
to place several strain-gauge load cells under the measurement plane to convert deformation into weight.
5.2 Body weight
The primary data type of a weighing scale device is body weight. It has measurement units of kilograms
(kg) or pounds (lb).
5.3 Body height
If body mass index reporting is supported, then body height is required. Body height denotes the actual
height of the person using a weighing scale device. It has measurement units of centimeters (cm) or inches
(in). This observation is typically entered manually.
5.4 Body mass index
The body mass index (BMI) is a measure for indicating an overweight or underweight condition of a person
and is defined as the individual’s body weight, in kilograms, divided by the square of height, in meters (see
Garrow and Webster [B1]):
body weight [kg]
BMI =
body height squared [m ]
BMI is not measured directly but is derived from body weight and body height. In the case where pounds
and inches are used as measurement units instead of kilograms and meters, the BMI may be calculated as
follows:
body weight [lb]
BMI = 703×
body height squared [in ]
Using the value 703 as a conversion factor gives a relative error with respect to using kilograms and meters
of less than 0.01%.
6. Weighing scale domain information model
6.1 Overview
This clause describes the domain information model of the weighing scale.
6.2 Class extensions
In this standard, no class extensions are defined with respect to IEEE Std 11073-20601.
© IEEE 2010 – All rights reserved
6.3 Object instance diagram
The object instance diagram of the weighing scale 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 6.4 to 6.12. This includes the medical device
system (MDS) object (see 6.5), the numeric objects (see 6.6), the real-time sample array (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 weighing scale information model beyond elements as described
in this standard. Each clause that describes an object of the weighing scale contains the following
information:
⎯ The nomenclature code used to identify the class of the object. One example of 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. Attributes types are defined using ASN.1. 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.
⎯ 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 is referenced, then it
contains the conditions), R — Attribute is Recommended, NR — Attribute is Not Recommended, and O —
Attribute is Optional. Mandatory attributes shall be implemented by the agent. Conditional attributes shall
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.
© IEEE 2010 – All rights reserved
PHD-Weighing Scale object instances
MDMDSS
WWeeiigghihingng S Sccaallee
11 11 11
1 0.1 0.1
NNuumerimericc NNuumerimericc NNuumerimericc
Body Weight
Body Weight BoBoddyy H Heeigighhtt BBooddyy M Maass Iss Inndedexx
Figure 1 —Weighing scale—domain information model
6.4 Types of configuration
6.4.1 General
As specified in IEEE Std 11073-20601, 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 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 the manager. If the manager acknowledges that it
recognizes and wants to operate using the configuration, then the agent can send measurements
immediately. If the manager does not understand the configuration, the agent provides the configuration
prior to transmitting measurement information.
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 are used in a configuration and assigns a configuration identifier.
When the agent associates with a manager, it negotiates an acceptable configuration. Typically, the
manager does not recognize the agent’s configuration on the first connection, so the manager responds that
the agent must send its configuration information as a configuration event report. If, however, the manager
already 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.
© IEEE 2010 – All rights reserved
6.5 Medical device system object
6.5.1 MDS object attributes
Table 1 summarizes the attributes of the weighing scale 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. C
System-Model {“Manufacturer”,”Model”}. M
System-Id Extended unique identifier (64 bits) (EUI-64). M
Dev-Configuration-Id Standard config: 0x05DC (1500). M
Extended configs: 0x4000–0x7FFF.
Attribute-Value-Map See IEEE Std 11073-20601. C
Production-Specification See IEEE Std 11073-20601. O
Mds-Time-Info See IEEE Std 11073-20601. C
Date-and-Time See IEEE Std 11073-20601. C
Relative-Time See IEEE Std 11073-20601. C
HiRes-Relative-Time See IEEE Std 11073-20601. C
Date-and-Time-Adjustment See IEEE Std 11073-20601. C
Power-Status onBattery or onMains. R
Battery-Level See IEEE Std 11073-20601. R
Remaining-Battery-Time See IEEE Std 11073-20601. R
Reg-Cert-Data-List See IEEE Std 11073-20601. O
System-Type-Spec-List {MDC_DEV_SPEC_PROFILE_SCALE, 1}. M
Confirm-Timeout See IEEE Std 11073-20601. O
NOTE—See IEEE Std 11073-20601 for information on whether an attribute is static or dynamic.
In the response to a Get MDS object command, only implemented attributes and their corresponding values
are returned.
See IEEE Std 11073-20601 for descriptive explanations of the individual attributes as well as for
information on attribute ID and attribute type.
The Dev-Configuration-Id attribute holds a locally unique 16-bit identifier that identifies the device
configuration. For a weighing scale agent with extended configuration, this identifier is chosen in the range
of extended-config-start to extended-config-end (see IEEE Std 11073-20601) as shown in Table 1.
The agent sends the Dev-Configuration-Id during the Associating state (see 8.3) to identify its configuration
for the duration of the association. If the manager already holds the configuration information relating to
the Dev-Configuration-Id, it recognizes the Dev-Configuration-Id. Then the Configuring state (see 8.4) is
skipped, and the agent and manager enter the Operating state. If the manager does not recognize the Dev-
Configuration-Id, the agent and manager enter the Configuring state.
If an agent implements multiple IEEE 11073-104zz specializations, System-Type-Spec-List is a list of
type/version pairs, each referencing the respective device specialization and version of that specialization.
© IEEE 2010 – All rights reserved
6.5.2 MDS object methods
Table 2 defines the methods (actions) of the MDS object. These methods are invoked using the Action
service. In Table 2, the Subservice type name column defines the name of the method; the Mode column
defines whether the method is invoked as an unconfirmed action (i.e., roiv-cmip-action from
IEEE Std 11073-20601) or a confirmed action (i.e., roiv-cmip-confirmed-action); the Subservice type
(action-type) column defines the nomenclature code to use in the action-type field of an action request and
response (see IEEE Std 11073-20601); the Parameters (action-info-args) column defines the associated
ASN.1 data structure (see IEEE Std 11073-20601 for ASN.1 definitions) to use in the action message for
the action-info-args field of the request; and the Results (action-info-args) column defines the structure to
use in the action-info-args of the response.
Table 2 —MDS object methods
Service Subservice Mode Subservice type Parameters Results
type name (action-type) (action-info-args) (action-info-args)
ACTION Set-Time Confirmed MDC_ACT_SET_TI SetTimeInvoke —
ME
Set-Time
This method allows the manager to set a real-time clock in the agent with the absolute time. The agent
indicates whether the Set-Time command is valid using the mds-time-capab-set-clock bit in the Mds-Time-
Info attribute (see IEEE Std 11073-20601). Agents with an internal real-time clock (RTC) shall indicate
this capability by also setting the mds-time-capab-real-time-clock bit in the Mds-Time-Info attribute.
Agents following only this device specialization and no others shall send event reports (see 6.5.3) using
agent-initiated measurement data transmission. Agents following this device specialization as well as others
shall send event reports in the appropriate fashion. During the association procedure (see 8.3),
DataReqModeCapab shall be set to the appropriate value for the event report style. Implementation of the
MDS-Data-Request method/action is not required in this standard and is not shown in Table 2.
6.5.3 MDS object events
Table 3 defines the events that can be sent by the weighing scale MDS object.
Table 3 —Weighing scale MDS object events
Service Subservice type name Mode Subservice type Parameters Results
(event-type) (event-info) (event-reply-
info)
MDS-Configuration- Confirmed MDC_NOTI_CONFIG ConfigReport ConfigReportR
Event sp
MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_RScanReportInfoVar —
Update-Var EPORT_VAR
EVENT MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_RScanReportInfoFixed —
REPORT
Update-Fixed EPORT_FIXED
MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_R ScanReportInfoMPVar —
Update-MP-Var EPORT_MP_VAR
MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_R ScanReportInfoMPFixed —
Update-MP-Fixed EPORT_MP_FIXED
⎯ MDS-Configuration-Event:
This event is sent by the weighing scale agent during the configuring procedure if the manager
does not already know the weighing scale agent’s configuration from past associations or
because the manager has not been implemented to recognize the configuration according to the
weighing scale device specialization. The event provides static information about the supported
measurement capabilities of the weighing scale agent.
© IEEE 2010 – All rights reserved
⎯ MDS-Dynamic-Data-Update-Var:
This event provides dynamic measurement data from the weighing scale agent for the body
weight and optionally the body height and BMI numeric object(s). These data are reported using
a generic attribute list variable format. The event is sent as an unsolicited message by the agent
(i.e., an agent-initiated measurement data transmission). See 8.5.3 for more information on
unsolicited event reporting.
⎯ MDS-Dynamic-Data-Update-Fixed:
This event provides dynamic measurement data from the weighing scale agent for the body
weight and optionally the body height and BMI numeric objects. These data are reported in the
fixed format defined by the Attribute-Value-Map attribute of the object(s). The event is sent as
an unsolicited message by the agent (i.e., an agent-initiated measurement data transmission). See
8.5.3 for more information on unsolicited event reporting.
⎯ MDS-Dynamic-Data-Update-MP-Var:
This is the same as MDS-Dynamic-Data-Update-Var but allows inclusion of data from multiple
people.
⎯ MDS-Dynamic-Data-Update-MP-Fixed:
This is the same as MDS-Dynamic-Data-Update-Fixed but allows inclusion of data from
multiple people.
NOTE— IEEE Std 11073-20601 requires that managers support all of the MDS object events listed above.
6.5.4 Other MDS services
6.5.4.1 GET service
A weighing scale agent shall support the GET service, which is provided by the MDS object to retrieve the
values of all implemented MDS object attributes. The GET service can be invoked as soon as the weighing
scale agent receives the Association Response and moves to the Associated state, including the Operating
and Configuring substates.
The manager may request the MDS object attributes of the weighing scale agent; in which case, the
manager shall send the “Remote Operation Invoke | Get” message (see roiv-cmip-get in IEEE Std 11073-
20601) with the reserved MDS handle value of 0. The weighing scale agent shall report its MDS object
attributes to the manager using the “Remote Operation Response | Get” message (see rors-cmip-get in
IEEE Std 11073-20601). See Table 4 for a summary of the GET service including some message fields.
Table 4 —Weighing scale MDS object GET service
Service Subservice Mode Subservice Parameters Results
type name type
GET GetArgumentSimple GetResultSimple
confirmed> = (obj-handle = 0), = (obj-handle = 0), attribute-
attribute-id-list list
See 8.5.2 for details on the procedure for getting the MDS object attributes.
© IEEE 2010 – All rights reserved
6.5.4.2 SET service
The weighing scale specialization does not require an implementation to support the MDS object SET
service.
6.6 Numeric objects
6.6.1 General
The weighing scale DIM (see Figure 1) contains one required numeric object for body weight and two
optional numeric objects for body height and body mass index. These are described in 6.6.2 to 6.6.4.
Sometimes, the interpretation of one attribute value in an object depends on other attribute values in the
same object. For example, Unit-Code and Unit-LabelString provide context for the observed values.
Whenever a contextual attribute changes, the agent shall report these changes to the manager using an MDS
object event (see 6.5.3) prior to reporting any of the dependent values.
6.6.2 Body weight
Table 5 summarizes the attributes of the body weight numeric object. The nomenclature code to identify the
numeric class is MDC_MOC_VMO_METRIC_NU. The body weight numeric object shall be supported by
a weighing scale agent.
Table 5 —Body weight numeric object attributes
Attribute name Extended configuration Standard configuration
(Dev-Configuration-Id = 0x05DC)
Value Qual. Value Qual.
Handle See IEEE Std 11073-20601. M 1 M
Type MDC_PART_SC
...
INTERNATIONAL ISO/IEEE
STANDARD 11073-10415
First edition
2010-05-01
Health informatics — Personal health
device communication —
Part 10415:
Device specialization — Weighing scale
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10415: Spécialisation des dispositifs — Plateau de balance
Reference number
©
ISO 2010
©
IEEE 2010
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© ISO 2010
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Published in Switzerland
ii © IEEE 2010 – All rights reserved
Contents Page
Foreword. v
Introduction.vii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations. 2
3.1 Definitions. 2
3.2 Acronyms and abbreviations. 3
4. Introduction to ISO/IEEE 11073 personal health devices. 3
4.1 General. 3
4.2 Introduction to IEEE 11073-20601 modeling constructs. 4
5. Weighing scale device concepts and modalities . 4
5.1 General. 4
5.2 Body weight . 5
5.3 Body height. 5
5.4 Body mass index . 5
6. Weighing scale domain information model . 5
6.1 Overview. 5
6.2 Class extensions . 5
6.3 Object instance diagram. 6
6.4 Types of configuration . 7
6.5 Medical device system object . 8
6.6 Numeric objects . 11
6.7 Real-time sample array objects . 15
6.8 Enumeration objects. 15
6.9 PM-store objects . 15
6.10 Scanner objects . 15
6.11 Class extension objects . 15
6.12 Weighing scale information model extensibility rules. 15
7. Weighing scale service model. 15
7.1 General. 15
7.2 Object access services. 15
7.3 Object access event report services. 17
© IEEE 2010 – All rights reserved iii
8. Weighing scale communication model . 17
8.1 Overview. 17
8.2 Communications characteristics. 17
8.3 Association procedure. 18
8.4 Configuring procedure . 19
8.5 Operating procedure. 21
8.6 Time synchronization. 21
9. Test associations . 21
9.1 Behavior with standard configuration . 22
9.2 Behavior with extended configurations. 22
10. Conformance. 22
10.1 Applicability. 22
10.2 Conformance specification. 22
10.3 Levels of conformance. 23
10.4 Implementation conformance statements. 23
Annex A (informative) Bibliography. 28
Annex B (normative) Any additional ASN.1 definitions. 29
Annex C (normative) Allocation of identifiers . 30
Annex D (informative) Message sequence examples . 31
Annex E (informative) Protocol data unit examples. 33
iv © IEEE 2010 – All rights reserved
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 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 11073-10415 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-10415-2008). 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. Both parties are responsible for the
maintenance of this document.
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: Domain information model
— Part 10404: Device specialization — Pulse oximeter
© IEEE 2010 – All rights reserved v
— Part 10407: Device specialization — Blood pressure monitor
— Part 10408: (Point-of-care medical device communication) Device specialization —
Thermometer
— Part 10415: (Point-of-care medical device communication) Device specialization — Weighing
scale
— Part 10417: Device specialization — Glucose meter
— Part 10471: (Point-of-care medical device communication) Device specialization —
Independant living activity hub
— Part 20101: (Point-of-care medical device communication) Application profiles — Base
standard
— Part 20601: (Point-of-care medical device communication) 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
vi © IEEE 2010 – All rights reserved
Introduction
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This
a
document uses the optimized framework created in IEEE Std 11073-20601 and describes a specific, interoperable
communication approach for weighing scales. These standards align with, and draw upon, the existing clinically
focused standards to provide support for communication of data from clinical or personal health devices.
a
For information on references, see Clause 2.
© IEEE 2010 – All rights reserved vii
INTERNATIONAL STANDARD ISO/IEEE 11073-10415:2010(E)
Health informatics — Personal health device
communication —
Part 10415:
Device specialization — Weighing scale
IMPORTANT NOTICE: This standard is not intended to assure safety, security, health, or
environmental protection in all circumstances. 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 communication between personal telehealth weighing scale 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 weighing scales.
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.
© IEEE 2010 – All rights reserved
1.3 Context
TM
See IEEE Std 11073-20601 for an overview of the environment within which this standard is written.
This document, IEEE Std 11073-10415, defines the device specialization for the weighing scale, 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 [B4] and ISO/IEEE 11073-20101:2004 [B5]. The medical device encoding
rules (MDER) used within this standard are fully described in IEEE Std 11073-20601.
This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B3]
and adds new nomenclature codes for the purposes of this standard. Between this standard and
IEEE Std 11073-20601, 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, 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.
TM
IEEE Std 11073-20601 -2008, Health informatics—Personal health device communication—Part 20601:
3, 4
Application profile—Optimized Exchange Protocol.
See Annex A for all informative material referenced by this standard.
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this standard, the following terms and definitions apply. The Authoritative Dictionary of
IEEE Standards [B2] should be referenced for terms not defined in this clause.
3.1.1. agent: A node that collects and transmits personal health data to an associated manager.
3.1.2. class: In object-oriented modeling, it describes the attributes, methods, and events that objects
instantiated from the class utilize.
3.1.3. compute engine: See: manager.
3.1.4. device: A term used to refer to a physical apparatus implementing either an agent or a manager role.
3.1.5. handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances
within an agent.
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.
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, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
© IEEE 2010 – All rights reserved
3.1.6. 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.
3.1.7. mass: An intrinsic property of matter that can be measured using the effect of the gravitational field
on an object.
3.1.8. obj-handle: See: handle.
3.1.9. object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
3.1.10. personal health device: A device used in personal health applications.
3.1.11. personal telehealth device: See: personal health device.
3.1.12. 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.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
BMI body mass index
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
PHD personal health device
RT-SA real-time sample array
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 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 weighing scale device. It describes all aspects necessary to
implement the application layer services and data exchange protocol between an ISO/IEEE 11073 PHD
weighing scale agent and a manager. This standard defines a subset of the objects and functionality
contained in IEEE Std 11073-20601 and extends and adds definitions where appropriate. All new
definitions are given in Annex B in Abstract Syntax Notation One (ASN.1) [B6]. Nomenclature codes
referenced in this standard, which are not defined in ISO/IEEE 11073-20601, are normatively defined in
Annex C.
© IEEE 2010 – All rights reserved
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 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 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 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.
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
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.
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. Weighing scale device concepts and modalities
5.1 General
This clause presents the general concepts of weighing scale devices. In the context of personal health
devices in this family of standards, a weighing scale is a device that measures the body weight of a person
and, optionally, determines other physiological quantities (e.g., the body mass index or the height of a
person). Weighing scale devices considered in this standard are typically placed on the floor with a person
stepping on the device to perform a weight measurement, with the result being converted into mass
internally of the device.
© IEEE 2010 – All rights reserved
In the personal health context, the body weight of a person is typically not measured more frequently than
twice a day.
Weighing scale devices may use a variety of techniques for measuring body weight. One typical method is
to place several strain-gauge load cells under the measurement plane to convert deformation into weight.
5.2 Body weight
The primary data type of a weighing scale device is body weight. It has measurement units of kilograms
(kg) or pounds (lb).
5.3 Body height
If body mass index reporting is supported, then body height is required. Body height denotes the actual
height of the person using a weighing scale device. It has measurement units of centimeters (cm) or inches
(in). This observation is typically entered manually.
5.4 Body mass index
The body mass index (BMI) is a measure for indicating an overweight or underweight condition of a person
and is defined as the individual’s body weight, in kilograms, divided by the square of height, in meters (see
Garrow and Webster [B1]):
body weight [kg]
BMI =
body height squared [m ]
BMI is not measured directly but is derived from body weight and body height. In the case where pounds
and inches are used as measurement units instead of kilograms and meters, the BMI may be calculated as
follows:
body weight [lb]
BMI = 703×
body height squared [in ]
Using the value 703 as a conversion factor gives a relative error with respect to using kilograms and meters
of less than 0.01%.
6. Weighing scale domain information model
6.1 Overview
This clause describes the domain information model of the weighing scale.
6.2 Class extensions
In this standard, no class extensions are defined with respect to IEEE Std 11073-20601.
© IEEE 2010 – All rights reserved
6.3 Object instance diagram
The object instance diagram of the weighing scale 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 6.4 to 6.12. This includes the medical device
system (MDS) object (see 6.5), the numeric objects (see 6.6), the real-time sample array (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 weighing scale information model beyond elements as described
in this standard. Each clause that describes an object of the weighing scale contains the following
information:
⎯ The nomenclature code used to identify the class of the object. One example of 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. Attributes types are defined using ASN.1. 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.
⎯ 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 is referenced, then it
contains the conditions), R — Attribute is Recommended, NR — Attribute is Not Recommended, and O —
Attribute is Optional. Mandatory attributes shall be implemented by the agent. Conditional attributes shall
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.
© IEEE 2010 – All rights reserved
PHD-Weighing Scale object instances
MDMDSS
WWeeiigghihingng S Sccaallee
11 11 11
1 0.1 0.1
NNuumerimericc NNuumerimericc NNuumerimericc
Body Weight
Body Weight BoBoddyy H Heeigighhtt BBooddyy M Maass Iss Inndedexx
Figure 1 —Weighing scale—domain information model
6.4 Types of configuration
6.4.1 General
As specified in IEEE Std 11073-20601, 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 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 the manager. If the manager acknowledges that it
recognizes and wants to operate using the configuration, then the agent can send measurements
immediately. If the manager does not understand the configuration, the agent provides the configuration
prior to transmitting measurement information.
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 are used in a configuration and assigns a configuration identifier.
When the agent associates with a manager, it negotiates an acceptable configuration. Typically, the
manager does not recognize the agent’s configuration on the first connection, so the manager responds that
the agent must send its configuration information as a configuration event report. If, however, the manager
already 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.
© IEEE 2010 – All rights reserved
6.5 Medical device system object
6.5.1 MDS object attributes
Table 1 summarizes the attributes of the weighing scale 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. C
System-Model {“Manufacturer”,”Model”}. M
System-Id Extended unique identifier (64 bits) (EUI-64). M
Dev-Configuration-Id Standard config: 0x05DC (1500). M
Extended configs: 0x4000–0x7FFF.
Attribute-Value-Map See IEEE Std 11073-20601. C
Production-Specification See IEEE Std 11073-20601. O
Mds-Time-Info See IEEE Std 11073-20601. C
Date-and-Time See IEEE Std 11073-20601. C
Relative-Time See IEEE Std 11073-20601. C
HiRes-Relative-Time See IEEE Std 11073-20601. C
Date-and-Time-Adjustment See IEEE Std 11073-20601. C
Power-Status onBattery or onMains. R
Battery-Level See IEEE Std 11073-20601. R
Remaining-Battery-Time See IEEE Std 11073-20601. R
Reg-Cert-Data-List See IEEE Std 11073-20601. O
System-Type-Spec-List {MDC_DEV_SPEC_PROFILE_SCALE, 1}. M
Confirm-Timeout See IEEE Std 11073-20601. O
NOTE—See IEEE Std 11073-20601 for information on whether an attribute is static or dynamic.
In the response to a Get MDS object command, only implemented attributes and their corresponding values
are returned.
See IEEE Std 11073-20601 for descriptive explanations of the individual attributes as well as for
information on attribute ID and attribute type.
The Dev-Configuration-Id attribute holds a locally unique 16-bit identifier that identifies the device
configuration. For a weighing scale agent with extended configuration, this identifier is chosen in the range
of extended-config-start to extended-config-end (see IEEE Std 11073-20601) as shown in Table 1.
The agent sends the Dev-Configuration-Id during the Associating state (see 8.3) to identify its configuration
for the duration of the association. If the manager already holds the configuration information relating to
the Dev-Configuration-Id, it recognizes the Dev-Configuration-Id. Then the Configuring state (see 8.4) is
skipped, and the agent and manager enter the Operating state. If the manager does not recognize the Dev-
Configuration-Id, the agent and manager enter the Configuring state.
If an agent implements multiple IEEE 11073-104zz specializations, System-Type-Spec-List is a list of
type/version pairs, each referencing the respective device specialization and version of that specialization.
© IEEE 2010 – All rights reserved
6.5.2 MDS object methods
Table 2 defines the methods (actions) of the MDS object. These methods are invoked using the Action
service. In Table 2, the Subservice type name column defines the name of the method; the Mode column
defines whether the method is invoked as an unconfirmed action (i.e., roiv-cmip-action from
IEEE Std 11073-20601) or a confirmed action (i.e., roiv-cmip-confirmed-action); the Subservice type
(action-type) column defines the nomenclature code to use in the action-type field of an action request and
response (see IEEE Std 11073-20601); the Parameters (action-info-args) column defines the associated
ASN.1 data structure (see IEEE Std 11073-20601 for ASN.1 definitions) to use in the action message for
the action-info-args field of the request; and the Results (action-info-args) column defines the structure to
use in the action-info-args of the response.
Table 2 —MDS object methods
Service Subservice Mode Subservice type Parameters Results
type name (action-type) (action-info-args) (action-info-args)
ACTION Set-Time Confirmed MDC_ACT_SET_TI SetTimeInvoke —
ME
Set-Time
This method allows the manager to set a real-time clock in the agent with the absolute time. The agent
indicates whether the Set-Time command is valid using the mds-time-capab-set-clock bit in the Mds-Time-
Info attribute (see IEEE Std 11073-20601). Agents with an internal real-time clock (RTC) shall indicate
this capability by also setting the mds-time-capab-real-time-clock bit in the Mds-Time-Info attribute.
Agents following only this device specialization and no others shall send event reports (see 6.5.3) using
agent-initiated measurement data transmission. Agents following this device specialization as well as others
shall send event reports in the appropriate fashion. During the association procedure (see 8.3),
DataReqModeCapab shall be set to the appropriate value for the event report style. Implementation of the
MDS-Data-Request method/action is not required in this standard and is not shown in Table 2.
6.5.3 MDS object events
Table 3 defines the events that can be sent by the weighing scale MDS object.
Table 3 —Weighing scale MDS object events
Service Subservice type name Mode Subservice type Parameters Results
(event-type) (event-info) (event-reply-
info)
MDS-Configuration- Confirmed MDC_NOTI_CONFIG ConfigReport ConfigReportR
Event sp
MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_RScanReportInfoVar —
Update-Var EPORT_VAR
EVENT MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_RScanReportInfoFixed —
REPORT
Update-Fixed EPORT_FIXED
MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_R ScanReportInfoMPVar —
Update-MP-Var EPORT_MP_VAR
MDS-Dynamic-Data- Confirmed MDC_NOTI_SCAN_R ScanReportInfoMPFixed —
Update-MP-Fixed EPORT_MP_FIXED
⎯ MDS-Configuration-Event:
This event is sent by the weighing scale agent during the configuring procedure if the manager
does not already know the weighing scale agent’s configuration from past associations or
because the manager has not been implemented to recognize the configuration according to the
weighing scale device specialization. The event provides static information about the supported
measurement capabilities of the weighing scale agent.
© IEEE 2010 – All rights reserved
⎯ MDS-Dynamic-Data-Update-Var:
This event provides dynamic measurement data from the weighing scale agent for the body
weight and optionally the body height and BMI numeric object(s). These data are reported using
a generic attribute list variable format. The event is sent as an unsolicited message by the agent
(i.e., an agent-initiated measurement data transmission). See 8.5.3 for more information on
unsolicited event reporting.
⎯ MDS-Dynamic-Data-Update-Fixed:
This event provides dynamic measurement data from the weighing scale agent for the body
weight and optionally the body height and BMI numeric objects. These data are reported in the
fixed format defined by the Attribute-Value-Map attribute of the object(s). The event is sent as
an unsolicited message by the agent (i.e., an agent-initiated measurement data transmission). See
8.5.3 for more information on unsolicited event reporting.
⎯ MDS-Dynamic-Data-Update-MP-Var:
This is the same as MDS-Dynamic-Data-Update-Var but allows inclusion of data from multiple
people.
⎯ MDS-Dynamic-Data-Update-MP-Fixed:
This is the same as MDS-Dynamic-Data-Update-Fixed but allows inclusion of data from
multiple people.
NOTE— IEEE Std 11073-20601 requires that managers support all of the MDS object events listed above.
6.5.4 Other MDS services
6.5.4.1 GET service
A weighing scale agent shall support the GET service, which is provided by the MDS object to retrieve the
values of all implemented MDS object attributes. The GET service can be invoked as soon as the weighing
scale agent receives the Association Response and moves to the Associated state, including the Operating
and Configuring substates.
The manager may request the MDS object attributes of the weighing scale agent; in which case, the
manager shall send the “Remote Operation Invoke | Get” message (see roiv-cmip-get in IEEE Std 11073-
20601) with the reserved MDS handle value of 0. The weighing scale agent shall report its MDS object
attributes to the manager using the “Remote Operation Response | Get” message (see rors-cmip-get in
IEEE Std 11073-20601). See Table 4 for a summary of the GET service including some message fields.
Table 4 —Weighing scale MDS object GET service
Service Subservice Mode Subservice Parameters Results
type name type
GET GetArgumentSimple GetResultSimple
confirmed> = (obj-handle = 0), = (obj-handle = 0), attribute-
attribute-id-list list
See 8.5.2 for details on the procedure for getting the MDS object attributes.
© IEEE 2010 – All rights reserved
6.5.4.2 SET service
The weighing scale specialization does not require an implementation to support the MDS object SET
service.
6.6 Numeric objects
6.6.1 General
The weighing scale DIM (see Figure 1) contains one required numeric object for body weight and two
optional numeric objects for body height and body mass index. These are described in 6.6.2 to 6.6.4.
Sometimes, the interpretation of one attribute value in an object depends on other attribute values in the
same object. For example, Unit-Code and Unit-LabelString provide context for the observed values.
Whenever a contextual attribute changes, the agent shall report these changes to the manager using an MDS
object event (see 6.5.3) prior to reporting any of the dependent values.
6.6.2 Body weight
Table 5 summarizes the attributes of the body weight numeric object. The nomenclature code to identify the
numeric class is MDC_MOC_VMO_METRIC_NU. The body weight numeric object shall be supported by
a weighing scale agent.
Table 5 —Body weight numeric object attributes
Attribute name Extended configuration Standard configuration
(Dev-Configuration-Id = 0x05DC)
Value Qual. Value Qual.
Handle See IEEE Std 11073-20601. M 1 M
Type MDC_PART_SCADA | M MDC_PART_SCADA
...
NORME ISO/
INTERNATIONALE IEEE
11073-10415
Première édition
2010-05-01
Informatique de santé — Communication
entre dispositifs de santé personnels —
Partie 10415:
Spécialisation des dispositifs — Plateau
de balance
Health informatics — Personal health device communication —
Part 10415: Device specialization — Weighing scale
Numéro de référence
©
ISO 2010
©
IEEE 2010
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ii © IEEE 2010 – Tous droits réservés
Sommaire Page
1. Description.1
1.1 Domaine d'application.1
1.2 Objet .1
1.3 Contexte.2
2. Références normatives.2
3. Définitions, acronymes et abréviations .2
3.1 Définitions.2
3.2 Acronymes et abréviations .3
4. Introduction à l'ISO/IEEE 11073 portant sur les dispositifs personnels de santé.4
4.1 Généralités.4
4.2 Introduction aux constructions de modélisation de l'IEEE 11073-20601.4
5. Concepts et modalités relatifs aux dispositifs de balances .5
5.1 Généralités.5
5.2 Poids du corps .5
5.3 Hauteur du corps .5
5.4 Indice de masse corporelle.5
6. Modèle d'informations du domaine de la balance .6
6.1 Description .6
6.2 Extensions de classes.6
6.3 Diagramme d'instance d'objet .6
6.4 Types de configurations .7
6.5 Objet système de dispositif médical.8
6.6 Objets numériques.12
6.7 Objets groupement d'échantillons en temps réel.16
6.8 Objets énumération .16
6.9 Objets PM-store.16
6.10 Objets analyseur .16
6.11 Objets extensions de classe.16
6.12 Règles d'extensibilité de modèle d'informations de la balance.16
7. Modèle de services de balance.17
7.1 Généralités.17
7.2 Services d'accès à l'objet.17
7.3 Services de rapport d'événement d'accès à l'objet.19
8. Modèle de communication de la balance .19
8.1 Description générale.19
8.2 Caractéristiques de communication.19
8.3 Procédure d'association .20
8.4 Procédure «Configuration» (procédure de configuration) .21
8.5 Procédure «Operating» (procédure de fonctionnement).23
8.6 Synchronisation dans le temps.23
9. Associations pour test.23
9.1 Comportement avec la configuration normalisée .24
9.2 Comportement avec des configurations étendues .24
10. Conformité .24
10.1 Applicabilité.24
10.2 Spécification de conformité.24
10.3 Niveaux de conformité .25
10.4 Déclarations de conformité de la réalisation .25
© IEEE 2010 – Tous droits réservés iii
Annexe A (informative) Bibliographie.30
Annexe B (normative) Toutes les définitions supplémentaires de l'ASN.1.31
Annexe C (normative) Allocation d'identificateurs .32
Annexe D (informative) Exemples de séquences de messages .33
Annexe E (informative) Exemples d'unités de données de protocole.36
iv © IEEE 2010 – Tous droits réservés
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des normes internationales
est en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une
étude a le droit de faire partie du comité technique créé à cet effet. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec l'ISO participent
également aux travaux. L'ISO collabore étroitement avec la Commission électrotechnique
internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les documents normatifs de l'IEEE sont développés au sein des sociétés de l'IEEE et des Comités
de Coordination des normes du Conseil des normes de l'Association des normes IEEE (IEEE-SA).
L'IEEE développe ses normes par le biais d'un processus de développement de consensus
approuvé par l'American National Standard Institute, qui rassemble des volontaires représentant
divers points de vue et divers intérêts pour parvenir au produit final. Les volontaires ne sont pas
nécessairement des membres de l'Institut et aucune compensation ne leur est attribuée. Bien que
l'IEEE administre le processus et établisse des règles pour favoriser l'équité au cours du processus
de développement du consensus, l'IEEE n'évalue pas, ne teste pas ou ne vérifie pas de manière
indépendante l'exactitude des informations contenues dans ses normes.
La tâche principale des comités techniques est d'élaborer les normes internationales. Les projets de
normes internationales adoptés par les comités techniques sont soumis aux comités membres pour
vote. Leur publication comme normes internationales requiert l'approbation de 75 % au moins des
comités membres votants.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire
l'objet de droits de propriété intellectuelle ou de droits analogues. Du fait de la publication de la
présente norme, aucune position n'est adoptée en ce qui concerne l'existence ou la validité de droit
quelconque de brevet en rapport avec celle-ci. Il n'incombe pas à l'ISO/IEEE d'identifier des brevets
essentiels ou des revendications de brevet pour lesquels une licence peut être requise, ni de
conduire des enquêtes en ce qui concerne la validité légale ou la portée des brevets ou des
revendications de brevet ou de déterminer si des termes ou conditions d'attribution de licence
fournis en rapport avec la soumission d'une lettre d'assurance ou d'une déclaration de brevet et du
formulaire de déclaration d'attribution de licence, s'il y en a, ou dans des accords d'attribution de
licence quelconques sont raisonnables ou non discriminatoires. Les utilisateurs de la présente
norme sont expressément avisés que la détermination de la validité de tout droit de brevet et le
risque de violation de ces droits leur incombent entièrement. Des informations supplémentaires
peuvent être obtenues auprès de l'ISO ou de l'Association des normes IEEE.
L'ISO/IEEE 11073-10415 a été élaborée par le Comité 11073 de la Société d'Ingénierie en
Médecine et Biologie de l'IEEE (en tant que norme IEEE 11073-10415:2008). Elle a été adoptée par
le comité technique ISO/TC 215, Informatique de santé, parallèlement à son approbation par les
organismes membres de l'ISO dans le cadre de la «procédure rapide» définie par l'accord de
coopération entre les Organisations Partenaires de Développement de normes que sont l'ISO et
l'IEEE. Les deux parties sont responsables de la tenue à jour du présent document.
L'ISO/IEEE 11073 comprend les parties suivantes, présentées sous le titre général Informatique de
santé — Communication entre dispositifs de santé personnels (le texte entre parenthèses donne
une variante du sous-titre):
⎯ Partie 10101: (Communication entre dispositifs médicaux sur le site des soins) Nomenclature
⎯ Partie 10201: (Communication entre dispositifs médicaux sur le site des soins) Modèle
d'informations du domaine
© IEEE 2010 – Tous droits réservés v
⎯ Partie 10404: Spécialisation des dispositifs — Oxymètre de pouls
⎯ Partie 10407: Spécialisation des dispositifs — Moniteur de pression sanguine
⎯ Partie 10408: (Communication entre dispositifs de santé personnels) Spécialisation des
dispositifs — Thermomètre
⎯ Partie 10415: (Communication entre dispositifs de santé personnels) Spécialisation des
dispositifs — Plateau de balance
⎯ Partie 10417: Spécialisation des dispositifs — Glucomètre
⎯ Partie 10471: (Communication entre dispositifs de santé personnels) Spécialisation des
dispositifs — Concentrateur d'activités pour une vie autonome
⎯ Partie 20101: (Communication entre dispositifs médicaux sur le site des soins) Profils
d'applications — Norme de base
⎯ Partie 20601: (Communication entre dispositifs de santé personnels) Profil d'application —
Protocole d'échange optimisé
⎯ Partie 30200: (Communication entre dispositifs médicaux sur le site des soins) Profil de
transport — Connexion par câble
⎯ Partie 30300: (Communication entre dispositifs médicaux sur le site des soins) Profil de
transport — Faisceau infrarouge
vi © IEEE 2010 – Tous droits réservés
Introduction
Les normes ISO/IEEE 11073 permettent des communications entre des dispositifs médicaux et des
systèmes informatiques externes. Le présent document utilise le cadre optimisé créé dans
1)
et décrit une approche de communication interopérable spécifique pour les
l'IEEE 11073-20601
plateaux de balances. Ces normes s'alignent sur et s'inspirent des normes existantes focalisées sur
les sujets cliniques pour fournir un support de communication de données depuis les dispositifs de
santé cliniques ou personnels.
1)
Pour des informations sur les références, se reporter à l'Article 2.
© IEEE 2010 – Tous droits réservés vii
NORME INTERNATIONALE ISO/IEEE 11073-10415:2010(F)
Informatique de santé — Communication entre dispositifs
de santé personnels —
Partie 10415:
Spécialisation des dispositifs — Plateau de balance
NOTE IMPORTANTE : La présente norme n'a pas pour but d'assurer la sécurité, la sûreté,
la santé ou la protection de l'environnement dans toutes les circonstances. Il incombe aux
personnes ou organismes mettant en œuvre la norme de déterminer les exigences
appropriées en matière de sécurité, de sûreté, d'environnement et de pratiques de santé
ou d'exigences réglementaires.
Le présent document de l'IEEE est mis à disposition afin d'être utilisé sous réserve de
notes importantes et de rejets de responsabilité légale. Ces notes et rejets de
responsabilité apparaissent dans toutes les publications contenant le présent document et
peuvent être trouvés sous l'en-tête «Note importante» ou «Notes importantes et rejets de
responsabilité concernant les documents de l'IEEE». Ils peuvent également être obtenus
sur demande auprès de l'IEEE ou visualisés sur le site:
http://standards.ieee.org/IPR/disclaimers.html.
1. Description
1.1 Domaine d'application
Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication entre des
dispositifs, la présente norme établit une définition normative de la communication entre des
dispositifs de balances personnelles de télésanté et des moteurs informatiques (par exemple des
téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et 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, des
modèles d'informations, des normes de profils d'applications et des normes de transport de
l'ISO/IEEE 11073. 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. La présente norme définit un noyau commun de
fonctionnalités de communication pour les balances personnelles de télésanté.
1.2 Objet
La présente norme répond au besoin d'une norme indépendante définie de manière ouverte
portant sur la commande de l'échange d'informations entre des dispositifs personnels de santé et
des moteurs informatiques (par exemple des téléphones cellulaires, des ordinateurs personnels,
des équipements personnels de santé et des boîtiers décodeurs). L'interopérabilité est la clé de la
croissance du marché potentiel de ces dispositifs et pour permettre aux personnes d'être des
acteurs mieux informés dans la gestion de leur santé.
© IEEE 2010 – Tous droits réservés 1
1.3 Contexte
Voir la norme IEEE 11073-20601 pour une description générale de l'environnement dans lequel la
présente norme est écrite.
La présente norme définit la spécialisation des dispositifs pour une balance, qui est un type
d'agent spécifique, et elle fournit une description des concepts du dispositif, de ses capacités et de
sa mise en œuvre conformément à la présente norme.
La présente norme est basée sur l'IEEE 11073-20601, qui à son tour tire ses informations de
2)
l'ISO/IEEE 11073-10201:2004 [B4] et de l'ISO/IEEE 11073-20101:2004 [B5]. Les règles de
codage des dispositifs médicaux (MDER) utilisées dans la présente norme sont décrites en totalité
dans l'IEEE 11073-20601.
La présente norme reproduit les parties appropriées de la nomenclature qui se trouve dans
l'ISO/IEEE 11073-10101:2004 [B3] et ajoute de nouveaux codes de nomenclature pour les
besoins de la présente norme. Entre la présente norme et l'IEEE 11073-20601, tous les codes de
nomenclature requis pour la mise en œuvre font l'objet de documents.
NOTE Dans la présente norme, le terme IEEE 11073-104zz est utilisé pour faire référence à l'ensemble de
normes relatives à la spécialisation des dispositifs qui utilisent l'IEEE 11073-20601 et zz peut être tout
3)
nombre de 01 à 99 inclus .
2. Références normatives
Les documents de référence suivants sont indispensables pour l'application du présent document
(c'est-à-dire qu'ils doivent être compris et utilisés de sorte que chaque document de référence soit
cité dans le texte et que sa relation avec le présent document soit expliquée). Pour les références
datées, seule l'édition citée s'applique. Pour les références non datées, la dernière édition du
document de référence s'applique (y compris les éventuels amendements).
IEEE 11073-20601:2008, Informatique de santé — Communication entre des dispositifs de santé
4) 5)
personnels — Partie 20601: Profil d'application — Protocole d'échange optimisé
Voir l'Annexe A pour tous les éléments informatifs indiqués en référence dans la présente norme.
3. Définitions, acronymes et abréviations
3.1 Définitions
Pour les besoins du présent document, les termes et définitions suivants s'appliquent. Il convient
de faire référence à «The Authoritative Dictionary of IEEE Standards Terms [B2]» en ce qui
concerne les termes qui ne sont pas définis dans le présent article.
3.1.1 agent: nœud qui collecte et transmet des données personnelles de santé à un gestionnaire
associé
3.1.2 classe: dans une modélisation orientée objet, elle décrit les attributs, les méthodes et les
événements que les objets instanciés à partir de la classe utilisent
2)
Les numéros entre crochets correspondent à ceux de la bibliographie à l'Annexe A.
3)
Les notes dans le texte, les tableaux et les figures sont données pour informations seulement et ne
contiennent pas des exigences nécessaires à l'utilisation de la présente norme.
4)
Les normes ou les produits IEEE auxquels il est fait référence dans le présent article sont des marques
commerciales de l'Institute of Electrical and Electronics Engineers, Inc.
5)
Les publications de l'IEEE sont disponibles auprès de l'Institute of Electrical and Electronics Engineers,
445 Hoes Lane, Piscataway, NJ 08854, USA (http://standards.ieee.org).
2 © IEEE 2010 – Tous droits réservés
3.1.3 moteur informatique: voir gestionnaire.
3.1.4 dispositif: terme utilisé pour désigner un appareil physique mettant en œuvre un agent ou
ayant un rôle de gestionnaire
3.1.5 poignée: nombre de 16 bits sans signe qui est unique localement et identifie l'une des
instances d'objet dans un agent
3.1.6 gestionnaire: nœud recevant des données d'un ou de plusieurs systèmes d'agents.
Certains exemples de gestionnaires incluent un téléphone cellulaire, un appareil de santé, un
boîtier décodeur ou un système informatique
3.1.7 masse: propriété intrinsèque d'un corps qui peut être mesurée en utilisant l'effet du champ
gravitationnel appliqué à un objet
3.1.8 poignée-objet (obj-handle): voir poignée.
3.1.9 objet: dans une modélisation orientée objet, instanciation particulière d'une classe.
L'instanciation réalise des attributs, des méthodes et des événements à partir de la classe
3.1.10 dispositif personnel de santé: dispositif utilisé dans des applications de santé
personnelles
3.1.11 dispositif personnel de télésanté: voir dispositif personnel de santé.
3.1.12 poids: force qui résulte de l'application de la gravité à un objet. Le poids est directement
proportionnel à la masse de l'objet. Cependant, dans le domaine des soins de santé, l'expression
«poids du corps» est souvent utilisée pour désigner la masse du corps d'une personne. Cette
notation s'applique à la présente norme.
3.2 Acronymes et abréviations
APDU application protocol data unit (unité de données de protocole d'application)
ASN.1 Abstract Syntax Notation One (notation à syntaxe abstraite un)
BPM beats per minute (battements par minute)
DIM domain information model (modèle d'informations du domaine)
EUI-64 extended unique identifier (64 bits) [identificateur unique étendu (64 bits)]
ICS implementation conformance statement (mention de conformité pour la mise en
œuvre)
MAP mean arterial pressure (pression artérielle moyenne)
MDC medical device communication (communication entre dispositifs médicaux)
MDER medical device encoding rules (règles de codage de dispositif médical)
MDS medical device system (système de dispositif médical)
MOC managed object class (classe d'objet géré)
RT-SA real-time sample array (groupement d'échantillons en temps réel)
PDU protocol data unit (unité de données de protocole)
PHD personal health device (dispositif personnel de santé)
VMO virtual medical object (objet médical virtuel)
VMS virtual medical system (système médical virtuel)
© IEEE 2010 – Tous droits réservés 3
4. Introduction à l'ISO/IEEE 11073 portant sur
les dispositifs personnels de santé
4.1 Généralités
La présente norme et le reste de la série des normes ISO/IEEE 11073 portant sur les dispositifs
personnels de santé (PHD) s'intègrent dans le contexte plus large de la série des normes
ISO/IEEE 11073. La suite complète de normes permet aux agents de s'interconnecter et
d'interopérer avec les gestionnaires et avec les systèmes d'informations informatisés de soins.
Voir l'IEEE 11073-20601 pour une description des principes directeurs pour cette série de normes
ISO/IEEE 11073 portant sur les dispositifs personnels de santé.
L'IEEE 11073-20601 prend en charge la modélisation et la mise en œuvre d'un ensemble
important de dispositifs personnels de santé. La présente norme définit des aspects du dispositif
de balance. Elle décrit tous les aspects nécessaires à la mise en œuvre des services de la couche
d'application et du protocole d'échange de données entre un agent balance de l'ISO/IEEE 11073
PHD et un gestionnaire. La présente norme définit un sous-ensemble des objets et la
fonctionnalité définie dans l'IEEE 11073-20601 et ajoute de nouvelles définitions de modélisation
lorsque cela est approprié. Toutes les nouvelles définitions sont données à l'Annexe B en Notation
de syntaxe abstraite numéro un (ASN.1) [B6]. Les codes de nomenclature auxquels il est fait
référence dans la présente norme, qui ne sont pas définis dans l'ISO/IEEE 11073-20601, sont
définis de manière normative à l'Annexe C.
4.2 Introduction aux constructions de modélisation de
l'IEEE 11073-20601
4.2.1 Généralités
La série de normes ISO/IEEE 11073, et en particulier l'IEEE 11073-20601, est fondée sur un
paradigme de gestion de systèmes orientée objet. Le modèle de système global est divisé en trois
principales composantes: le modèle d'informations du domaine (DIM), le modèle de service et le
modèle de communication. Voir l'IEEE 11073-20601 pour une description détaillée des
constructions de la modélisation.
4.2.2 Modèle d'informations du domaine (DIM)
Le DIM est un modèle hiérarchique qui décrit un agent sous la forme d'un ensemble d'objets. Ces
objets et leurs attributs représentent les éléments qui déterminent le comportement et rapportent
l'état de l'agent et les données qu'un agent peut communiquer à un gestionnaire. La
communication entre l'agent et le gestionnaire est définie par le protocole d'application dans
l'IEEE 11073-20601.
4.2.3 Modèle de service
Le modèle de service définit les mécanismes conceptuels pour les services d'échange de
données. De tels services sont mappés sur des messages qui sont échangés entre l'agent et le
gestionnaire. Les messages de protocole dans la série de normes ISO/IEEE 11073 sont définis en
ASN.1. Les messages définis dans l'IEEE 11073-20601 peuvent coexister avec les messages
définis dans les autres profils d'application de normes définis dans la série de normes
ISO/IEEE 11073.
4.2.4 Modèle de communication
D'une manière générale, le modèle de communication prend en charge la topologie d'un ou de
plusieurs agents qui communiquent sur des connexions logiques de point à point avec un seul
gestionnaire. Pour chaque connexion logique de point à point, le comportement dynamique du
système est défini par une machine à états finis de connexion, telle que spécifiée dans
l'IEEE 11073-20601.
4 © IEEE 2010 – Tous droits réservés
4.2.5 Mise en œuvre des modèles
Un agent mettant en œuvre la présente norme doit mettre en œuvre tous les éléments obligatoires
des modèles d'informations, de service et de communication, de même que tous les éléments
conditionnels où la condition est satisfaite. Il convient que l'agent mette en œuvre les éléments
recommandés et il peut mettre en œuvre toute combinaison des éléments optionnels. Un
gestionnaire mettant en œuvre la présente norme doit utiliser au moins l'un des éléments
obligatoires, conditionnels, recommandés ou optionnels. Dans ce contexte, «utiliser» signifie
utiliser l'élément en tant que partie de la fonction primaire du dispositif gestionnaire. Par exemple,
un gestionnaire dont la fonction primaire consiste à afficher des données devrait afficher un
élément de données dans l'élément pour l'utiliser.
5. Concepts et modalités relatifs aux dispositifs de
balances
5.1 Généralités
Le présent article présente les concepts généraux relatifs aux dispositifs de balances. Dans le
contexte des dispositifs personnels de santé de cette famille de normes, une balance est un
dispositif qui mesure le poids du corps d'une personne et détermine éventuellement d'autres
quantités physiologiques (par exemple, l'indice de masse corporelle ou la hauteur d'une personne).
Les dispositifs de balances considérés dans la présente norme sont habituellement placés sur le sol,
la personne montant sur le dispositif pour effectuer un mesurage de son poids, le résultat étant
converti en masse à l'intérieur du dispositif.
Dans le contexte de la santé personnelle, le poids du corps d'une personne n'est habituellement
mesuré pas plus de deux fois par jour.
Les dispositifs de balances peuvent utiliser diverses techniques pour mesurer le poids du corps. Une
méthode courante consiste à placer plusieurs cellules d'extensométrie sous le plan de mesurage
pour convertir la déformation en poids.
5.2 Poids du corps
Le type principal de données d'un dispositif de balance est le poids du corps. Il peut être exprimé en
kilogrammes (kg) ou en livres (lb).
5.3 Hauteur du corps
Si le dispositif de balance est conçu pour permettre la détermination de l'indice de masse corporelle,
alors la hauteur du corps est nécessaire. La hauteur du corps désigne la hauteur réelle de la personne
utilisant un dispositif de balance. Elle peut être exprimée en centimètres (cm) ou en inches (in) et est
habituellement entrée manuellement.
5.4 Indice de masse corporelle
L'indice de masse corporelle (IMC) est une mesure destinée à indiquer un état de surpoids ou
d'insuffisance pondérale et est défini comme le poids du corps de la personne, en kilogrammes,
divisé par le carré de sa hauteur, en mètres (voir Garrow et Webster [B1]):
poids du corps [kg]
IMC=
hauteur du corps au carré [m ]
L'IMC n'est pas mesuré directement mais est déterminé à partir du poids et de la hauteur du corps.
Si, au lieu des kilogrammes et des mètres, les unités utilisées sont des livres et des inches, l'indice
IMC peut être calculé de la façon suivante:
poids du corps [lb]
IMC=×703
hauteur du corps au carré [in ]
© IEEE 2010 – Tous droits réservés 5
L'utilisation de la valeur 703 comme facteur de conversion conduit à une erreur relative inférieure à
0,01 % par rapport au résultat d'IMC obtenu en utilisant des kilogrammes et des mètres.
6. Modèle d'informations du domaine de la balance
6.1 Description
Le présent article décrit le modèle d'informations du domaine de la balance.
6.2 Extensions de classes
Dans la présente norme, aucune extension de classe n'est définie en ce qui concerne
l'IEEE 11073-20601.
6.3 Diagramme d'instance d'objet
Le diagramme d'instance d'objet du modèle d'informations du domaine de la balance, défini pour
les besoins de la présente norme, est représenté à la Figure 1.
Les objets du DIM, tels qu'ils sont représentés à la Figure 1, sont décrits de 6.4 à 6.12. Ceci inclut
l'objet système de dispositif médical (MDS) (voir 6.5), les objets numériques (voir 6.6), les objets
groupement d'échantillons en temps réel (RT-SA) (voir 6.7), les objets énumération (voir 6.8), les
objets PM-store (voir 6.9) et les objets analyseur (voir 6.10) dans la balance. Voir 6.11 pour les
règles d'extension du modèle d'informations de la balance au-delà des éléments tels que décrits
dans la présente norme. Chaque paragraphe qui décrit un objet de la balance contient les
informations suivantes.
– Le code de nomenclature utilisé pour identifier la classe de l'objet. Un exemple de l'endroit
où ce code est utilisé est l'événement de configuration, où la classe d'objet est signalée pour
chaque objet. Cela permet au gestionnaire de déterminer si la classe de l'objet qui est
spécifiée est une classe numérique, une classe de groupement d'échantillons en temps réel,
une classe énumération, une classe d'analyseur ou une classe PM-store.
– Les attributs de l'objet. Chaque objet a des attributs qui représentent et acheminent des
informations sur le dispositif physique et ses sources de données. Chaque objet a un attribut
Poignée qui identifie l'instance d'objet dans un agent. Les valeurs des attributs font l'objet d'un
accès et elles sont modifiées en utilisant des méthodes telles que GET et SET. Les types
d'attributs sont définis en utilisant une notation ASN.1. Les définitions de la notation ASN.1
pour de nouveaux types d'attributs spécifiques de la présente norme se trouvent à l'Annexe B
et les définitions de l'ASN.1 pour les types d'attributs existants auxquels il est fait référence
dans la présente norme se trouvent dans l'IEEE 11073-20601.
– Les méthodes disponibles sur l'objet.
– Les événements potentiels générés par l'objet. Les données sont envoyées au gestionnaire
en utilisant des événements.
– Les services disponibles tels que l'obtention ou la fixation des attributs.
6 © IEEE 2010 – Tous droits réservés
Les attributs pour chaque classe sont définis dans des tables qui spécifient le nom de l'attribut, sa
valeur et son qualificateur. Les qualificateurs sont des lettres qui signifient: M – l'attribut est
obligatoire, C – l'attribut est conditionnel et dépend de la condition mentionnée dans la colonne
Remarque ou Valeur (s'il est fait référence à l'IEEE 11073-20601, alors elle contient les
conditions), R — l'attribut est recommandé, NR — l'attribut n'est pas recommandé et O — l'attribut
est optionnel. Les attributs obligatoires doivent être mis en œuvre par l'agent. Les attributs
conditionnels doivent être mis en œuvre si la condition s'applique et peuvent être mis en œuvre
d'une autre manière. Il convient que l'agent mette en œuvre les attributs recommandés. Il convient
que l'agent ne mette pas en œuvre les attributs non recommandés. Les attributs optionnels
peuvent être mis en œuvre par l'agent.
Les attributs peuvent être soit statiques, ce qui signifie qu'ils doivent rester inchangés après que la
configuration a fait l'objet d'un accord, soit dynamiques, ce qui signifie que l'attribut peut changer à
un certain instant après la configuration.
PHD-Weighing Scale object instances
MDMDSS
WeiWeighighing Scang Scallee
11 11 11
1 0.1 0.1
NumericNumeric NumericNumeric NumericNumeric
BodBodyy Wei Weightght BodBodyy Hei Heightght BBoodydy Ma Massss I Innddeexx
Légende
PHD-Weighing Scale object instances Instances de l'objet balance-dispositif personnel de
santé
Weighing Scale Balance
Body Weight Poids du corps
Body Height Hauteur du corps
Body Mass Index Indice de masse corporelle
Numeric Valeur numérique
Figure 1 — Balance — Modèle d'informations du domaine
6.4 Types de configurations
6.4.1 Généralités
Comme spécifié dans l'IEEE 11073-20601, il existe deux styles de configurations disponibles. Les
paragraphes 6.4.2 et 6.4.3 introduisent brièvement la configuration normalisée et la configuration
étendue.
© IEEE 2010 – Tous droits réservés 7
6.4.2 Configuration normalisée
Les configurations normalisées sont définies dans les parties spécialisées de l'IEEE 11073-104zz
(par exemple dans la présente norme) et se voient affecter un identificateur bien connu (Dev-
Configuration-Id). L'utilisation de la configuration normalisée est négociée à l'instant de
l'association entre l'agent et le gestionnaire. Si le gestionnaire accuse réception du fait qu'il
reconnaît la configuration et qu'il souhaite fonctionner en utilisant la configuration, alors l'agent
peut envoyer les mesurages immédiatement. Si le gestionnaire ne reconnaît pas la configuration,
l'agent fournit la configuration avant de transmettre les informations de mesure.
6.4.3 Configuration étendue
Dans les configurations étendues, la configuration de l'agent n'est pas prédéfinie dans une norme.
L'agent détermine les objets, les attributs et les valeurs qu'il souhaite utiliser dans une
configuration et affecte un identificateur de configuration. Lorsque l'agent s'associe à un
gestionnaire, il négocie une configuration acceptable. Habituellement, le gestionnaire ne reconnaît
pas la configuration de l'agent à la première connexion, de sorte que le gestionnaire répond que
l'agent doit informer ses informations de configuration sous la forme d'un rapport d'événement de
configuration. Cependant, si le gestionnaire reconnaît la configuration, soit du fait qu'elle est
préchargée d'une certaine manière, soit du fait que l'agent s'est précédemment associé avec le
gestionnaire, alors le gestionnaire répond que la configuration est connue et qu'aucune information
de configuration supplémentaire ne doit être envoyée.
6.5 Objet système de dispositif médical
6.5.1 Attributs d'objet MDS
Le Tableau 1 constitue un récapitulatif des attributs de l'objet MDS balance. Le code de
nomenclature pour identifier la classe MDS est MDC_MOC_VMS_MDS_SIMP.
Tableau 1 — Attributs de l'objet MDS
Nom de l'attribut Valeur Qual.
Poignée 0 M
System-Type (Type de Attribut non présent. Voir l'IEEE 11073-20601. C
Système)
System Model (Modèle de {«Fabricant», «Modèle»}. M
Système)
System-Id (Identificateur du Identificateur unique étendu (64 bits) (EUI-64). M
système)
Dev-Configuration-Id Configuration normalisée: 05DC (1500) M
(Identificateur de configuration- Configurations étendues: 0x4000-0x7FFF.
Dev)
Attribute-Value-Map (Mappe de Voir l'IEEE 11073-20601. C
Valeurs d'Attributs)
Production-Specification Voir l'IEEE 11073-20601. O
(Spécification de fabrication)
Mds-Time-Info (Informations de Voir l'IEEE 11073-20601. C
Temps du Mds)
Date-And-Time (Date et Heure) Voir l'IEEE 11073-20601. C
Relative-Time (Heure Relative) Voir l'IEEE 11073-20601. C
HiRes-Relative-Time (Temps Voir l'IEEE 11073-20601. C
relatif HiRes)
Date-And-Time-Adjustment Voir l'IEEE 11073-20601. C
(Réglage de la Date et de
l'Heure)
Power-Status (Statut de Sur batterie ou sur secteur. R
l'alimentation)
Battery-Level (Niveau de la Voir l'IEEE 11073-20601. R
batterie)
8 © IEEE 2010 – Tous droits réservés
Remaining-Battery-Time Voir l'IEEE 11073-20601. R
(Temps restant pour la batterie)
Reg-Cert-Data-List (Liste de Voir l'IEEE 11073-20601. O
données Cert-Reg)
System-Type-Spec-List (Liste {MDC_DEV_SPEC_PROFILE_TEMP, 1}. M
de spécifications du type de
système)
Confirm-Timeout (Confirmer Voir l'IEEE 11073-20601. O
l'expiration du temps imparti)
NOTE Voir l'IEEE 11073-20601 pour des informations pour déterminer si un attribut est statique ou dynamique.
Dans la réponse à une commande Get de l'objet MDS, seuls les attributs mis en œuvre et leurs
valeurs correspondantes sont renvoyées.
Voir l'IEEE 11073-20601 pour des explications descriptives des attributs individuels de même que
pour des informations sur l'identificateur de l'attribut et sur le type d'attribut.
L'attribut Dev-Configuration-Id contient un identificateur localement unique de 16 bits qui identifie
la configuration du dispositif. Pour un agent balance doté d'une configuration étendue, cet
identificateur est choisi dans la plage de extended-config-start (début de configuration étendue) à
extended-config-end (fin de configuration étendue) (voir l'IEEE 11073-20601) comme indiqué dans
le Tableau 1.
L'agent envoie l'attribut Dev-Configuration-Id au cours de l'état Associating (association) (voir 8.3)
pour identifier sa configuration pendant la durée de l'association. Si le gestionnaire possède déjà
les informations de configuration se rapportant à l'attribut Dev-Configuration-Id, il reconnaît
l'attribut Dev-Configuration-Id et l'état Configuring (configuration) (voir 8.4) est sauté. L'agent et le
gestionnaire entrent alors dans l'état Operating (fonctionnement). Si le gestionnaire ne reconnaît
pas l'Attribut Dev-Configuration-Id, l'agent et le gestionnaire entrent dans l'état Configuring
(configuration).
Si un agent met en œuvre de multiples spécialisations selon l'IEEE 11073-104zz, l'attribut System-
Type-Spec-List est une liste de paires type/version, chacune faisant référence à la norme du
dispositif respectif et à la version de cette spécialisation.
6.5.2 Méthodes de l'objet MDS
Le Tableau 2 définit les méthodes (actions) de l'objet MDS. Ces méthodes sont appelées en
utilisant le service Action. Dans le Tableau 2, la colonne Subservice type name (nom de type de
sous-service) définit le nom de la méthode, la colonne Mode définit si la méthode est appelée en
tant qu'action non confirmée (c'est-à-dire roiv-cmip-action de l'IEEE 11073-20601) ou en tant
qu'action confirmée (c'est-à-dire, roiv-cmip-confirmed-action). La colonne Subservice type (type de
sous-service) (action-type) définit le code de nomenclature utilisé dans le champ action-type (type
d'action) d'une demande et d'une réponse d'action (voir l'IEEE 11073-20601). La colonne
Parameters (Paramètres) (action-info-args) définit la structure associée de données en notation
ASN.1 (voir l'IEEE 11073-20601 pour les définitions ASN.1) à utiliser dans le message d'action
pour le champ action-info-args de la demande et la colonne Results (résultats) (action-info-args)
définit la structure à utiliser dans les paramètres action-info-args de la réponse.
© IEEE 2010 – Tous droits réservés 9
Tableau 2 — Méthodes de l'objet MDS
Service Subservice Mode Subservice type Parameters Results
type name (Type de sous-service) (Paramètres) (Résultats)
(Nom de type
de sous- (action-type)
(action-info-args) (action-info-args)
service) (type d'action)
ACTION Set-Time Confirmed MDC_ACT_SET_TIME SetTimeInvoke —
(Régler le (Confirmé)
temps)
Set-Time (Réglage du Temps)
Cette méthode permet au gestionnaire de régler une horloge en temps réel dans l'agent sur le
temps absolu. L'agent indique si la commande Set-Time est valide en utilisant le bit mds-time-
capab-set-clock dans l'attribut Mds-Time- Info (voir l'IEEE 11073-20601). Les agents ayant une
horloge interne en temps réel (RTC) doivent indiquer cette capacité en armant également le bit
mds-time-capab-real-time-clock dans l'attribut Mds-Time-Info.
Les agents ne suivant que cette spécialisation de dispositif doivent envoyer des rapports
d'événements (voir 6.5.3) en utilisant une transmission de données de mesure initiée par l'agent.
Les autres agents ne doivent pas le faire. Les agents suivant cette spécialisation de dispositif ainsi
que les autres doivent envoyer des rapports d'événements de la manière appropriée. Au cou
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