ISO/IEEE 11073-20601:2010
(Main)Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol
ISO/IEEE 11703-20601:2010 defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible. ISO/IEEE 11703-20601:2010 addresses a need for an openly defined, independent standard for converting the information profile into an interoperable transmission format so the information can be exchanged to and from personal telehealth devices and computer engines (e.g., cell phones, personal computers, personal health appliances and set top boxes).
Informatique de santé — Communication entre dispositifs de santé personnels — Partie 20601: Profil d'application — Protocole d'échange optimisé
L'ISO/IEEE 11073-20601:2010 définit un cadre commun, pour rendre disponible un modèle abstrait de données relatives à la santé personnelle dans une syntaxe de transfert indépendante du transport requise pour établir des connexions logiques entre systèmes et pour fournir des capacités et des services de présentation nécessaires pour effectuer les tâches de communication. Le protocole est optimisé pour répondre aux exigences des utilisations relatives à la santé des personnes et s'appuie dans la mesure du possible sur des méthodes et des outils couramment utilisés. L'ISO/IEEE 11073-20601:2010 répond à la nécessité d'une norme indépendante définie de manière ouverte permettant de convertir le profil d'information en informant les transmissions internes opérables de sorte que les informations puissent être transmises vers des dispositifs personnels de télésanté et des moteurs informatiques.
General Information
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Frequently Asked Questions
ISO/IEEE 11073-20601:2010 is a standard published by the International Organization for Standardization (ISO). Its full title is "Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol". This standard covers: ISO/IEEE 11703-20601:2010 defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible. ISO/IEEE 11703-20601:2010 addresses a need for an openly defined, independent standard for converting the information profile into an interoperable transmission format so the information can be exchanged to and from personal telehealth devices and computer engines (e.g., cell phones, personal computers, personal health appliances and set top boxes).
ISO/IEEE 11703-20601:2010 defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible. ISO/IEEE 11703-20601:2010 addresses a need for an openly defined, independent standard for converting the information profile into an interoperable transmission format so the information can be exchanged to and from personal telehealth devices and computer engines (e.g., cell phones, personal computers, personal health appliances and set top boxes).
ISO/IEEE 11073-20601:2010 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 11073-20601:2010 has the following relationships with other standards: It is inter standard links to ISO 8871-3:2003, ISO/IEEE 11073-20601:2010/Amd 1:2015, ISO/IEEE 11073-20601:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO/IEEE 11073-20601:2010 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 11073-20601
First edition
2010-05-01
Health informatics — Personal health
device communication —
Part 20601:
Application profile — Optimized
exchange protocol
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 20601: Profil d'application — Protocole d'échange optimisé
Reference number
©
ISO 2010
©
IEEE 2010
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ii © IEEE 2010 – All rights reserved
Contents Page
Foreword. vi
Introduction. viii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 5
3. Definitions, acronyms, and abbreviations. 5
3.1 Definitions. 5
3.2 Acronyms and abbreviations. 5
4. Guiding principles. 6
5. Introduction to IEEE 11073 personal health devices . 7
5.1 General. 7
5.2 Domain information model (DIM). 8
5.3 Service model. 8
5.4 Communication model. 8
6. Personal health device DIM. 8
6.1 General. 8
6.2 Nomenclature usage. 9
6.3 Personal health object class definitions. 10
6.3.1 General . 10
6.3.2 MDS class . 12
6.3.3 Metric class. 18
6.3.4 Numeric class . 23
6.3.5 RT-SA class. 26
6.3.6 Enumeration class. 27
6.3.7 PM-store class . 30
6.3.8 PM-segment class. 34
6.3.9 Scanner classes . 37
6.4 Information model extensibility rules . 45
7. Personal health device service model . 45
7.1 General. 45
7.2 Association service . 46
7.3 Object access services. 46
7.4 Specific application of object access EVENT REPORT services for personal health devices . 47
7.4.1 General . 47
7.4.2 Confirmed and unconfirmed event reports. 47
© IEEE 2010 – All rights reserved iii
7.4.3 Configuration event report . 47
7.4.4 Agent- and manager-initiated measurement data transmission . 49
7.4.5 Variable, fixed, and grouped format event reports . 50
7.4.6 Single-person and multiple-person event reports . 50
7.4.7 Temporarily stored measurements. 51
8. Communication model. 52
8.1 General. 52
8.2 System context . 52
8.3 Communications characteristics. 53
8.3.1 General . 53
8.3.2 Common communications characteristics . 55
8.3.3 Reliable communications characteristics. 55
8.3.4 Best-effort communications characteristics. 56
8.4 State machines. 56
8.4.1 Agent state machine . 56
8.4.2 Manager state machine . 59
8.4.3 Timeout variables . 60
8.5 Connected procedure. 61
8.5.1 General . 61
8.5.2 Entry conditions . 61
8.5.3 Normal procedures . 61
8.5.4 Exit conditions. 61
8.5.5 Error conditions. 62
8.6 Unassociated procedure . 62
8.6.1 General . 62
8.6.2 Entry conditions . 62
8.6.3 Normal procedures . 62
8.6.4 Exit conditions. 62
8.6.5 Error conditions. 62
8.7 Associating procedure. 63
8.7.1 General . 63
8.7.2 Entry conditions . 63
8.7.3 Normal procedures . 63
8.7.4 Exit conditions. 67
8.7.5 Error conditions. 67
8.7.6 Test association . 67
8.8 Configuring procedure . 69
8.8.1 General . 69
8.8.2 Entry conditions . 69
8.8.3 Normal procedures . 69
8.8.4 Exit conditions. 71
8.8.5 Error conditions. 71
8.9 Operating procedure. 72
8.9.1 General . 72
8.9.2 Entry conditions . 72
8.9.3 Normal procedures . 72
8.9.4 Exit conditions. 83
8.9.5 Error conditions. 83
8.10 Disassociating procedure . 85
8.10.1 General . 85
8.10.2 Entry conditions . 85
8.10.3 Normal procedures . 85
8.10.4 Exit conditions. 85
8.10.5 Error conditions. 86
8.11 Message encoding. 86
8.12 Time coordination . 86
iv © IEEE 2010 – All rights reserved
8.12.1 General . 86
8.12.2 Absolute time . 86
8.12.3 Relative time. 88
8.12.4 High-resolution relative time. 89
9. Conformance model. 89
9.1 Applicability . 89
9.2 Conformance specification. 90
9.3 Implementation conformance statements (ICSs) . 90
9.4 General conformance . 90
9.4.1 General ICS . 91
9.4.2 Minimum requirements ICS . 92
9.4.3 Service support ICS. 93
9.5 Device additions/extensions ICS. 94
9.5.1 General additions/extensions ICS. 94
9.5.2 Personal health device DIM object and class (POC) ICS. 95
9.5.3 POC attribute ICS. 95
9.5.4 POC behavior ICS . 96
9.5.5 POC notification ICS. 96
9.5.6 POC nomenclature ICS . 97
Annex A (normative) ASN.1 definitions . 98
Annex B (informative) Scale and range specification example . 130
Annex C (informative) The PM-store concept. 132
Annex D (informative) Transport profile types . 137
Annex E (normative) State tables . 140
Annex F (normative) Medical device encoding rules (MDER) . 151
Annex G (informative) Encoded data type definitions . 163
Annex H (informative) Examples. 182
Annex I (normative) Nomenclature codes . 190
Annex J (informative) Derivation and modification history. 194
Annex K (informative) Bibliography. 197
© IEEE 2010 – All rights reserved v
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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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 11073-20601 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-20601-2008). 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
vi © IEEE 2010 – All rights reserved
— 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
© IEEE 2010 – All rights reserved vii
Introduction
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard and corresponding IEEE 11073-104zz standards address a need for a simplified and
optimized communication approach for personal health devices, which may or may not be regulated
devices. These standards align with, and draw upon, the existing clinically focused standards to provide
easy management of data from either a clinical or personal health device.
This document addresses a need for an openly defined, independent standard for converting the collected
information into an interoperable transmission format so the information can be exchanged between agents
and managers.
Other closely related standards include the following:
a
⎯ ISO/IEEE P11073-00103 [B8] provides an overview of the personal health space and defines the
underlying use cases and usage models.
⎯ ISO/IEEE 11073-10101 [B12] documents the nomenclature terms that can be used.
⎯ ISO/IEEE 11073-10201:2004 [B13] documents the extensive domain information model (DIM)
leveraged by this standard.
⎯ ISO/IEEE 11073-104zz standards define specific device specializations. For example, ISO/IEEE
P11073-10404 [B9] defines how interoperable pulse oximeters work.
⎯ ISO/IEEE 11073-20101:2004 [B14] defines the medical device encoding rules (MDER) used in this
standard.
a
The numbers in brackets correspond to the numbers of the bibliography in Annex K.
viii © IEEE 2010 – All rights reserved
INTERNATIONAL STANDARD ISO/IEEE 11073-20601:2010(E)
Health informatics — Personal health device
communication —
Part 20601:
Application profile — Optimized exchange protocol
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
defines a common framework for making an abstract model of personal health data available in transport-
independent transfer syntax required to establish logical connections between systems and to provide
presentation capabilities and services needed to perform communication tasks. The protocol is optimized to
personal health usage requirements and leverages commonly used methods and tools wherever possible.
1.2 Purpose
This document addresses a need for an openly defined, independent standard for converting the information
profile into an interoperable transmission format so the information can be exchanged to and from personal
telehealth devices and compute engines (e.g., cell phones, personal computers, personal health appliances,
and set top boxes).
© IEEE 2010 – All rights reserved
1.3 Context
Figure 1 shows categories and typical devices supporting the personal health space. Agents (e.g., blood
pressure monitors, weighing scales, and pedometers) collect information about a person (or persons) and
transfer the information to a manager (e.g., cell phone, health appliance, or personal computer) for
collection, display, and possible later transmission. The manager may also forward the data to remote
support services for further analysis. The information is available from a range of domains including
disease management, health and fitness, or aging independently applications.
The communication path between agent and manager is assumed to be a logical point-to-point connection.
Generally, an agent communicates with a single manager at any point in time. A manager may
communicate with multiple agents simultaneously using separate point-to-point connections.
The overlay shows the focus area of the IEEE 11073™ Personal Health Devices Working Group. The
primary concentration is the interface and data exchange between the agents and manager. However, this
interface cannot be created in isolation by ignoring the remainder of the solution space. Remaining
cognizant of the entire system helps to ensure that data can reasonably move from the agents all the way to
the remote support services when necessary. This path may include converting the data format, exchange
protocols, and transport protocols across different interfaces. Much of the standardization effort is outside
of the scope of the Personal Health Devices Working Group; however, aligning all standardization efforts
allows data to flow seamlessly through the overall set of systems.
Figure 1 —Overall context of work
Figure 2 shows a hierarchical view of the architecture of an agent or manager superimposed with a view of
the related standards. The application layers are, for the most part, not specific to any particular transport.
Where necessary, this standard identifies assumptions that require direct support by a transport or a “shim”
layer above the transport. This approach allows support for various transports. The definition of the
transports is outside the scope of this standard and the working group.
© IEEE 2010 – All rights reserved
Above the transport layer is the Optimized Exchange Protocol (described in this standard). This protocol
consists of two aspects: the application layer services and the definition of the data exchange protocol
between agents and managers. The application layer services provide the protocol for connection
management and reliable transfer of actions and data between agent and manager. The data exchange
protocol defines the commands, agent configuration information, data format, and overall protocol. The
Optimized Exchange Protocol provides the basis to support any type of agent. For a specific device type,
the reader is directed to the device specialization for that agent to understand the capabilities of the device
and its implementation according to this standard. The device specialization indicates which aspects of this
standard to comprehend and where further information to implement the device is found.
Above the exchange protocol are device specializations that describe specific details relative to the
particular agent (e.g., blood pressure monitor, weighing scale, or pedometer). The specializations describe
the details of how these agents work and act as a detailed description for creating a specific type of agent.
Additionally, they provide reference to a related standard for further details. The standard numbers reserved
for device specializations range from IEEE Std 11073-10401 through IEEE Std 11073-10499, inclusive.
When the collection of standards is being referenced, the term IEEE 11073-104zz is used where zz could be
any number in the range from 01 to 99, inclusive.
The ISO/IEEE P11073-00103 [B8] technical report describes the overall personal health space with further
definition of the underlying use cases and usage models.
Figure 2 —Document map
The personal health device specializations are not being created independently of all other standards. There
are a number of existing standards generated for clinical environments upon which these standards draw.
Figure 3 shows the relationship to the remainder of the IEEE 11073 documents. There are two types of
relationships:
The numbers in brackets correspond to the numbers of the bibliography in Annex K.
© IEEE 2010 – All rights reserved
⎯ Drawing ideas and/or content from the other documents (dashed lines)
⎯ Leveraging information from the other document and introducing new content into that document to
support this standard (solid lines)
This standard imports information from ISO/IEEE 11073-10201:2004 [B13] and ISO/IEEE 11073-
20101:2004 [B14] as normative annexes. If there is a discrepancy between these standards, this standard
takes priority. Because of the reuse of constructs from these standards, some of the names appear to be
more clinically focused [e.g., medical device system (MDS) instead of personal health device system];
however, to maintain consistency, the traditional names have been preserved.
This standard replicates relevant portions of ISO/IEEE 11073-10101 [B12] and incorporates new
nomenclature codes.
Figure 3 —Relationship to other IEEE 11073 documents
© IEEE 2010 – All rights reserved
2. Normative references
The following referenced documents are indispensable for the application of this standard (i.e., they must
be understood and used; therefore, each referenced document is cited in the text and its relationship to this
standard is explained). For dated references, only the edition cited applies. For undated references, the latest
edition of the referenced document (including any amendments or corrigenda) applies. ®
IEEE Std 802 -2001, IEEE Standard for Local and Metropolitan Area Networks: Overview and
Architecture.
ITU-T Rec. X.667 (Sept. 2004), Information technology – Open Systems Interconnection – Procedures for
the operation of OSI Registration Authorities: Generation and registration of universally unique identifiers
(UUIDs) and their use as ASN.1 object identifier components.
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 [B6] 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 compute engine: See: manager.
3.1.3 confirmed: An application-level, completion notification service mechanism. For EVENT REPORT
services (i.e., the data plane), confirmation allows the agent to know when the manager has “accepted
responsibility” for a piece of data so that the agent can delete that data. For the ACTION, GET, and SET
services (i.e., the control plane), confirmation allows the manager to know when the agent has “completed”
the requested transaction.
3.1.4 device: A physical device implementing either an agent or 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.
3.1.6 manager: A node receiving data from one or more agent systems. Examples of managers include a
cellular phone, health appliance, set top box, or computer system.
3.1.7 personal health device: A device used in personal health applications.
3.1.8 personal telehealth device: See: personal health device.
3.2 Acronyms and abbreviations
ASCII American Standard Code for Information Interchange
ASN.1 Abstract Syntax Notation One
APDU application protocol data unit
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
ITU-T publications are available from the International Telecommunications Union, Place des Nations, CH-1211, Geneva 20,
Switzerland/Suisse (http://www.itu.int/).
Note that throughout this standard the term ASCII is used to mean the character set as defined in ISO/IEC 646 (1991) [B7].
© IEEE 2010 – All rights reserved
AVA attribute value assertion
BER binary encoding rules
DIM domain information model
EUI-64 extended unique identifier (64 bits)
GMDN Global Medical Device Nomenclature
ICS implementation conformance statement
ID identifier
LSB least significant bit
MDER medical device encoding rules
MDNF medical device numeric format
MDS medical device system
MOC medical object class
MSB most significant bit
NaN not a number
NBO network byte order
NRes not at this resolution
NTP Network Time Protocol
OID object identifier
OUI organizationally unique identifier
PDU protocol data unit
PER packed encoding rules
POC personal health device domain information model object and class
RC retry count: association procedure
assoc
RTC real-time clock
RT-SA real-time sample array
SNTP Simple Network Time Protocol
TCP Transmission Control Protocol
TO timeout: association procedure
assoc
TO timeout: confirmed action service
ca
TO timeout: confirmed event report service for the MDS object
cer-mds
TO timeout: confirmed event report service for the PM-store object
cer-pms
TO timeout: confirmed event report service for the scanner object
cer-scan
TO timeout: confirmed action service to clear the PM-store object
clr-pms
TO timeout: configuration procedure
config
TO timeout: confirmed set service
cs
TO timeout: get service
get
TO timeout: association release procedure
release
TO timeout: special interservice timeout for the MDS object
sp-mds
TO timeout: special segment transfer timeout for the PM-segment object
sp-pms
UTC universal time coordinated
UUID universally unique identifier
USB universal serial bus
XER Extensible Markup Language (XML) encoding rules
4. Guiding principles
This standard and the other personal health device standards fit in the larger context of the ISO/IEEE 11073
family of standards. The full suite of standards enables agents to interconnect and interoperate with
managers and with computerized healthcare information systems.
The communication profile defined in this standard takes into account the specific requirements of personal
health agents and managers, which are typically used outside a clinical setting, e.g., mobile or in a person’s
home:
⎯ Personal health agents typically have very limited computing capabilities.
© IEEE 2010 – All rights reserved
⎯ Personal health agents typically have a fixed configuration, and they are used with a single manager
device.
⎯ Personal health agents are frequently battery powered, mobile devices, using a wireless communication
link. Therefore, energy efficiency of the protocol is an important aspect.
⎯ Personal health agents are often not permanently active. For example, a weighing scale may provide
data only once or twice a day. An efficient connection procedure is needed for minimum overhead for
such devices.
⎯ Personal health managers tend to have more processing power, memory, and storage space so the
protocol intentionally places more load on the managers.
⎯ Personal health agents and managers convey information that could be useful to clinical professionals.
As such, the quality of the data may be considered to have clinical merit even if acquired in a personal
health or remote monitoring environment.
The ISO/IEEE 11073 family of standards is based on an object-oriented systems management paradigm.
Data (measurement, state, and so on) are modeled in the form of information objects that are accessed and
manipulated using an object access service protocol.
To address the unique requirements of personal health devices, a specialized application profile is defined
in this standard. This profile leverages concepts from the ISO/IEEE 11073 family of standards and industry
best practices to define an optimized communication profile for this domain:
⎯ Where possible, the communication profile is not specific to any particular transport.
⎯ The information model of the communication profile is built on the ISO/IEEE 11073 domain
information model (DIM) and includes optimizations where possible.
⎯ An optimized communication protocol is defined to reduce message size, run-time packet construction,
and parsing overheads. This is possible due to the lower complexity of the devices in the personal
health domain.
⎯ Required definitions for a protocol implementation are included in this standard, rather than referenced.
This approach facilitates easier adoption of this standard. In the case of discrepancies between the
normative inclusions and a referenced document, this standard takes precedence.
Where possible, versions of this standard are fully backward compatible with at least two major versions.
NOTE—It is expected that any new additions to the DIM or other relevant parts of the ISO/IEEE 11073 family of
standards will be adopted and reflected in future revisions of those standards.
5. Introduction to IEEE 11073 personal health devices
5.1 General
The overall ISO/IEEE 11073 system model is divided into three principal components: the DIM, the
service model, and the communications model. These three models work together to represent data, define
data access and command methodologies, and communicate the data from an agent to a manager. Because
of the tight relationship between the models, the DIM, service model, and communications model are
briefly introduced in 5.2, 5.3, and 5.4, respectively, so that when they are described in more detail, in
Clause 6, Clause 7, and Clause 8, respectively, the basic concepts are familiar.
Notes in text, tables, and figures of a standard are given for information only and do not contain requirements needed to implement
the standard.
© IEEE 2010 – All rights reserved
5.2 Domain information model (DIM)
The DIM, described in detail in Clause 6, characterizes information from an agent as a set of objects. Each
object has one or more attributes. Attributes describe measurement data that are communicated to a
manager as well as elements that control behavior and report on the status of the agent.
5.3 Service model
The service model, described in detail in Clause 7, provides data access primitives that are sent between the
agent and manager to exchange data from the DIM. These primitives include commands such as Get, Set,
Action, and Event Report.
5.4 Communication model
The communication model, described in detail in Clause 8, supports the topology of one or more agents
communicating over point-to-point connections to a single mana
...
INTERNATIONAL ISO/IEEE
STANDARD 11073-20601
First edition
2010-05-01
Health informatics — Point-of-care
medical device communication —
Part 20601:
Application profile — Optimized
exchange protocol
Informatique de santé — Communication entre dispositifs médicaux
sur le site des soins —
Partie 20601: Profil d'application — Protocole d'échange optimisé
Reference number
©
ISO 2010
©
IEEE 2010
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ii © IEEE 2010 – All rights reserved
Contents Page
Foreword. vi
Introduction. viii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 5
3. Definitions, acronyms, and abbreviations. 5
3.1 Definitions. 5
3.2 Acronyms and abbreviations. 5
4. Guiding principles. 6
5. Introduction to IEEE 11073 personal health devices . 7
5.1 General. 7
5.2 Domain information model (DIM). 8
5.3 Service model. 8
5.4 Communication model. 8
6. Personal health device DIM. 8
6.1 General. 8
6.2 Nomenclature usage. 9
6.3 Personal health object class definitions. 10
6.3.1 General . 10
6.3.2 MDS class . 12
6.3.3 Metric class. 18
6.3.4 Numeric class . 23
6.3.5 RT-SA class. 26
6.3.6 Enumeration class. 27
6.3.7 PM-store class . 30
6.3.8 PM-segment class. 34
6.3.9 Scanner classes . 37
6.4 Information model extensibility rules . 45
7. Personal health device service model . 45
7.1 General. 45
7.2 Association service . 46
7.3 Object access services. 46
7.4 Specific application of object access EVENT REPORT services for personal health devices . 47
7.4.1 General . 47
7.4.2 Confirmed and unconfirmed event reports. 47
© IEEE 2010 – All rights reserved iii
7.4.3 Configuration event report . 47
7.4.4 Agent- and manager-initiated measurement data transmission . 49
7.4.5 Variable, fixed, and grouped format event reports . 50
7.4.6 Single-person and multiple-person event reports . 50
7.4.7 Temporarily stored measurements. 51
8. Communication model. 52
8.1 General. 52
8.2 System context . 52
8.3 Communications characteristics. 53
8.3.1 General . 53
8.3.2 Common communications characteristics . 55
8.3.3 Reliable communications characteristics. 55
8.3.4 Best-effort communications characteristics. 56
8.4 State machines. 56
8.4.1 Agent state machine . 56
8.4.2 Manager state machine . 59
8.4.3 Timeout variables . 60
8.5 Connected procedure. 61
8.5.1 General . 61
8.5.2 Entry conditions . 61
8.5.3 Normal procedures . 61
8.5.4 Exit conditions. 61
8.5.5 Error conditions. 62
8.6 Unassociated procedure . 62
8.6.1 General . 62
8.6.2 Entry conditions . 62
8.6.3 Normal procedures . 62
8.6.4 Exit conditions. 62
8.6.5 Error conditions. 62
8.7 Associating procedure. 63
8.7.1 General . 63
8.7.2 Entry conditions . 63
8.7.3 Normal procedures . 63
8.7.4 Exit conditions. 67
8.7.5 Error conditions. 67
8.7.6 Test association . 67
8.8 Configuring procedure . 69
8.8.1 General . 69
8.8.2 Entry conditions . 69
8.8.3 Normal procedures . 69
8.8.4 Exit conditions. 71
8.8.5 Error conditions. 71
8.9 Operating procedure. 72
8.9.1 General . 72
8.9.2 Entry conditions . 72
8.9.3 Normal procedures . 72
8.9.4 Exit conditions. 83
8.9.5 Error conditions. 83
8.10 Disassociating procedure . 85
8.10.1 General . 85
8.10.2 Entry conditions . 85
8.10.3 Normal procedures . 85
8.10.4 Exit conditions. 85
8.10.5 Error conditions. 86
8.11 Message encoding. 86
8.12 Time coordination . 86
iv © IEEE 2010 – All rights reserved
8.12.1 General . 86
8.12.2 Absolute time . 86
8.12.3 Relative time. 88
8.12.4 High-resolution relative time. 89
9. Conformance model. 89
9.1 Applicability . 89
9.2 Conformance specification. 90
9.3 Implementation conformance statements (ICSs) . 90
9.4 General conformance . 90
9.4.1 General ICS . 91
9.4.2 Minimum requirements ICS . 92
9.4.3 Service support ICS. 93
9.5 Device additions/extensions ICS. 94
9.5.1 General additions/extensions ICS. 94
9.5.2 Personal health device DIM object and class (POC) ICS. 95
9.5.3 POC attribute ICS. 95
9.5.4 POC behavior ICS . 96
9.5.5 POC notification ICS. 96
9.5.6 POC nomenclature ICS . 97
Annex A (normative) ASN.1 definitions . 98
Annex B (informative) Scale and range specification example . 130
Annex C (informative) The PM-store concept. 132
Annex D (informative) Transport profile types . 137
Annex E (normative) State tables . 140
Annex F (normative) Medical device encoding rules (MDER) . 151
Annex G (informative) Encoded data type definitions . 163
Annex H (informative) Examples. 182
Annex I (normative) Nomenclature codes . 190
Annex J (informative) Derivation and modification history. 194
Annex K (informative) Bibliography. 197
© IEEE 2010 – All rights reserved v
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 11073-20601 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-20601-2008). 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
vi © IEEE 2010 – All rights reserved
— 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
© IEEE 2010 – All rights reserved vii
Introduction
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard and corresponding IEEE 11073-104zz standards address a need for a simplified and
optimized communication approach for personal health devices, which may or may not be regulated
devices. These standards align with, and draw upon, the existing clinically focused standards to provide
easy management of data from either a clinical or personal health device.
This document addresses a need for an openly defined, independent standard for converting the collected
information into an interoperable transmission format so the information can be exchanged between agents
and managers.
Other closely related standards include the following:
a
⎯ ISO/IEEE P11073-00103 [B8] provides an overview of the personal health space and defines the
underlying use cases and usage models.
⎯ ISO/IEEE 11073-10101 [B12] documents the nomenclature terms that can be used.
⎯ ISO/IEEE 11073-10201:2004 [B13] documents the extensive domain information model (DIM)
leveraged by this standard.
⎯ ISO/IEEE 11073-104zz standards define specific device specializations. For example, ISO/IEEE
P11073-10404 [B9] defines how interoperable pulse oximeters work.
⎯ ISO/IEEE 11073-20101:2004 [B14] defines the medical device encoding rules (MDER) used in this
standard.
a
The numbers in brackets correspond to the numbers of the bibliography in Annex K.
viii © IEEE 2010 – All rights reserved
INTERNATIONAL STANDARD ISO/IEEE 11073-20601:2010(E)
Health informatics — Point-of-care medical device
communication —
Part 20601:
Application profile — Optimized exchange protocol
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
defines a common framework for making an abstract model of personal health data available in transport-
independent transfer syntax required to establish logical connections between systems and to provide
presentation capabilities and services needed to perform communication tasks. The protocol is optimized to
personal health usage requirements and leverages commonly used methods and tools wherever possible.
1.2 Purpose
This document addresses a need for an openly defined, independent standard for converting the information
profile into an interoperable transmission format so the information can be exchanged to and from personal
telehealth devices and compute engines (e.g., cell phones, personal computers, personal health appliances,
and set top boxes).
© IEEE 2010 – All rights reserved
1.3 Context
Figure 1 shows categories and typical devices supporting the personal health space. Agents (e.g., blood
pressure monitors, weighing scales, and pedometers) collect information about a person (or persons) and
transfer the information to a manager (e.g., cell phone, health appliance, or personal computer) for
collection, display, and possible later transmission. The manager may also forward the data to remote
support services for further analysis. The information is available from a range of domains including
disease management, health and fitness, or aging independently applications.
The communication path between agent and manager is assumed to be a logical point-to-point connection.
Generally, an agent communicates with a single manager at any point in time. A manager may
communicate with multiple agents simultaneously using separate point-to-point connections.
The overlay shows the focus area of the IEEE 11073™ Personal Health Devices Working Group. The
primary concentration is the interface and data exchange between the agents and manager. However, this
interface cannot be created in isolation by ignoring the remainder of the solution space. Remaining
cognizant of the entire system helps to ensure that data can reasonably move from the agents all the way to
the remote support services when necessary. This path may include converting the data format, exchange
protocols, and transport protocols across different interfaces. Much of the standardization effort is outside
of the scope of the Personal Health Devices Working Group; however, aligning all standardization efforts
allows data to flow seamlessly through the overall set of systems.
Figure 1 —Overall context of work
Figure 2 shows a hierarchical view of the architecture of an agent or manager superimposed with a view of
the related standards. The application layers are, for the most part, not specific to any particular transport.
Where necessary, this standard identifies assumptions that require direct support by a transport or a “shim”
layer above the transport. This approach allows support for various transports. The definition of the
transports is outside the scope of this standard and the working group.
© IEEE 2010 – All rights reserved
Above the transport layer is the Optimized Exchange Protocol (described in this standard). This protocol
consists of two aspects: the application layer services and the definition of the data exchange protocol
between agents and managers. The application layer services provide the protocol for connection
management and reliable transfer of actions and data between agent and manager. The data exchange
protocol defines the commands, agent configuration information, data format, and overall protocol. The
Optimized Exchange Protocol provides the basis to support any type of agent. For a specific device type,
the reader is directed to the device specialization for that agent to understand the capabilities of the device
and its implementation according to this standard. The device specialization indicates which aspects of this
standard to comprehend and where further information to implement the device is found.
Above the exchange protocol are device specializations that describe specific details relative to the
particular agent (e.g., blood pressure monitor, weighing scale, or pedometer). The specializations describe
the details of how these agents work and act as a detailed description for creating a specific type of agent.
Additionally, they provide reference to a related standard for further details. The standard numbers reserved
for device specializations range from IEEE Std 11073-10401 through IEEE Std 11073-10499, inclusive.
When the collection of standards is being referenced, the term IEEE 11073-104zz is used where zz could be
any number in the range from 01 to 99, inclusive.
The ISO/IEEE P11073-00103 [B8] technical report describes the overall personal health space with further
definition of the underlying use cases and usage models.
Figure 2 —Document map
The personal health device specializations are not being created independently of all other standards. There
are a number of existing standards generated for clinical environments upon which these standards draw.
Figure 3 shows the relationship to the remainder of the IEEE 11073 documents. There are two types of
relationships:
The numbers in brackets correspond to the numbers of the bibliography in Annex K.
© IEEE 2010 – All rights reserved
⎯ Drawing ideas and/or content from the other documents (dashed lines)
⎯ Leveraging information from the other document and introducing new content into that document to
support this standard (solid lines)
This standard imports information from ISO/IEEE 11073-10201:2004 [B13] and ISO/IEEE 11073-
20101:2004 [B14] as normative annexes. If there is a discrepancy between these standards, this standard
takes priority. Because of the reuse of constructs from these standards, some of the names appear to be
more clinically focused [e.g., medical device system (MDS) instead of personal health device system];
however, to maintain consistency, the traditional names have been preserved.
This standard replicates relevant portions of ISO/IEEE 11073-10101 [B12] and incorporates new
nomenclature codes.
Figure 3 —Relationship to other IEEE 11073 documents
© IEEE 2010 – All rights reserved
2. Normative references
The following referenced documents are indispensable for the application of this standard (i.e., they must
be understood and used; therefore, each referenced document is cited in the text and its relationship to this
standard is explained). For dated references, only the edition cited applies. For undated references, the latest
edition of the referenced document (including any amendments or corrigenda) applies. ®
IEEE Std 802 -2001, IEEE Standard for Local and Metropolitan Area Networks: Overview and
Architecture.
ITU-T Rec. X.667 (Sept. 2004), Information technology – Open Systems Interconnection – Procedures for
the operation of OSI Registration Authorities: Generation and registration of universally unique identifiers
(UUIDs) and their use as ASN.1 object identifier components.
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 [B6] 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 compute engine: See: manager.
3.1.3 confirmed: An application-level, completion notification service mechanism. For EVENT REPORT
services (i.e., the data plane), confirmation allows the agent to know when the manager has “accepted
responsibility” for a piece of data so that the agent can delete that data. For the ACTION, GET, and SET
services (i.e., the control plane), confirmation allows the manager to know when the agent has “completed”
the requested transaction.
3.1.4 device: A physical device implementing either an agent or 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.
3.1.6 manager: A node receiving data from one or more agent systems. Examples of managers include a
cellular phone, health appliance, set top box, or computer system.
3.1.7 personal health device: A device used in personal health applications.
3.1.8 personal telehealth device: See: personal health device.
3.2 Acronyms and abbreviations
ASCII American Standard Code for Information Interchange
ASN.1 Abstract Syntax Notation One
APDU application protocol data unit
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
ITU-T publications are available from the International Telecommunications Union, Place des Nations, CH-1211, Geneva 20,
Switzerland/Suisse (http://www.itu.int/).
Note that throughout this standard the term ASCII is used to mean the character set as defined in ISO/IEC 646 (1991) [B7].
© IEEE 2010 – All rights reserved
AVA attribute value assertion
BER binary encoding rules
DIM domain information model
EUI-64 extended unique identifier (64 bits)
GMDN Global Medical Device Nomenclature
ICS implementation conformance statement
ID identifier
LSB least significant bit
MDER medical device encoding rules
MDNF medical device numeric format
MDS medical device system
MOC medical object class
MSB most significant bit
NaN not a number
NBO network byte order
NRes not at this resolution
NTP Network Time Protocol
OID object identifier
OUI organizationally unique identifier
PDU protocol data unit
PER packed encoding rules
POC personal health device domain information model object and class
RC retry count: association procedure
assoc
RTC real-time clock
RT-SA real-time sample array
SNTP Simple Network Time Protocol
TCP Transmission Control Protocol
TO timeout: association procedure
assoc
TO timeout: confirmed action service
ca
TO timeout: confirmed event report service for the MDS object
cer-mds
TO timeout: confirmed event report service for the PM-store object
cer-pms
TO timeout: confirmed event report service for the scanner object
cer-scan
TO timeout: confirmed action service to clear the PM-store object
clr-pms
TO timeout: configuration procedure
config
TO timeout: confirmed set service
cs
TO timeout: get service
get
TO timeout: association release procedure
release
TO timeout: special interservice timeout for the MDS object
sp-mds
TO timeout: special segment transfer timeout for the PM-segment object
sp-pms
UTC universal time coordinated
UUID universally unique identifier
USB universal serial bus
XER Extensible Markup Language (XML) encoding rules
4. Guiding principles
This standard and the other personal health device standards fit in the larger context of the ISO/IEEE 11073
family of standards. The full suite of standards enables agents to interconnect and interoperate with
managers and with computerized healthcare information systems.
The communication profile defined in this standard takes into account the specific requirements of personal
health agents and managers, which are typically used outside a clinical setting, e.g., mobile or in a person’s
home:
⎯ Personal health agents typically have very limited computing capabilities.
© IEEE 2010 – All rights reserved
⎯ Personal health agents typically have a fixed configuration, and they are used with a single manager
device.
⎯ Personal health agents are frequently battery powered, mobile devices, using a wireless communication
link. Therefore, energy efficiency of the protocol is an important aspect.
⎯ Personal health agents are often not permanently active. For example, a weighing scale may provide
data only once or twice a day. An efficient connection procedure is needed for minimum overhead for
such devices.
⎯ Personal health managers tend to have more processing power, memory, and storage space so the
protocol intentionally places more load on the managers.
⎯ Personal health agents and managers convey information that could be useful to clinical professionals.
As such, the quality of the data may be considered to have clinical merit even if acquired in a personal
health or remote monitoring environment.
The ISO/IEEE 11073 family of standards is based on an object-oriented systems management paradigm.
Data (measurement, state, and so on) are modeled in the form of information objects that are accessed and
manipulated using an object access service protocol.
To address the unique requirements of personal health devices, a specialized application profile is defined
in this standard. This profile leverages concepts from the ISO/IEEE 11073 family of standards and industry
best practices to define an optimized communication profile for this domain:
⎯ Where possible, the communication profile is not specific to any particular transport.
⎯ The information model of the communication profile is built on the ISO/IEEE 11073 domain
information model (DIM) and includes optimizations where possible.
⎯ An optimized communication protocol is defined to reduce message size, run-time packet construction,
and parsing overheads. This is possible due to the lower complexity of the devices in the personal
health domain.
⎯ Required definitions for a protocol implementation are included in this standard, rather than referenced.
This approach facilitates easier adoption of this standard. In the case of discrepancies between the
normative inclusions and a referenced document, this standard takes precedence.
Where possible, versions of this standard are fully backward compatible with at least two major versions.
NOTE—It is expected that any new additions to the DIM or other relevant parts of the ISO/IEEE 11073 family of
standards will be adopted and reflected in future revisions of those standards.
5. Introduction to IEEE 11073 personal health devices
5.1 General
The overall ISO/IEEE 11073 system model is divided into three principal components: the DIM, the
service model, and the communications model. These three models work together to represent data, define
data access and command methodologies, and communicate the data from an agent to a manager. Because
of the tight relationship between the models, the DIM, service model, and communications model are
briefly introduced in 5.2, 5.3, and 5.4, respectively, so that when they are described in more detail, in
Clause 6, Clause 7, and Clause 8, respectively, the basic concepts are familiar.
Notes in text, tables, and figures of a standard are given for information only and do not contain requirements needed to implement
the standard.
© IEEE 2010 – All rights reserved
5.2 Domain information model (DIM)
The DIM, described in detail in Clause 6, characterizes information from an agent as a set of objects. Each
object has one or more attributes. Attributes describe measurement data that are communicated to a
manager as well as elements that control behavior and report on the status of the agent.
5.3 Service model
The service model, described in detail in Clause 7, provides data access primitives that are sent between the
agent and manager to exchange data from the DIM. These primitives include commands such as Get, Set,
Action, and Event Report.
5.4 Communication model
The communication model, described in detail in Clause 8, supports the topology of one or more agents
communicating over point-to-point conne
...
NORME ISO/
INTERNATIONALE IEEE
11073-20601
Première édition
2010-05-01
Informatique de santé — Communication
entre dispositifs de santé personnels —
Partie 20601:
Profil d'application — Protocole
d'échange optimisé
Health informatics — Personal health device communication —
Part 20601: Application profile — Optimized exchange protocol
Numéro de référence
©
ISO 2010
©
IEEE 2010
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Sommaire Page
1. Description générale. 1
1.1 Domaine d'application. 1
1.2 Objet . 1
1.3 Contexte. 2
2. Références normatives. 7
3. Définitions, acronymes et abréviations . 7
3.1 Définitions. 7
3.2 Acronymes et abréviations . 8
4. Principes directeurs. 9
5. Introduction aux dispositifs personnels de santé de l'IEEE 11073. 10
5.1 Généralités. 10
5.2 Modèle d'informations du domaine (DIM). 10
5.3 Modèle de service . 10
5.4 Modèle de communication. 10
6. Modèle DIM d'un dispositif personnel de santé. 11
6.1 Généralités. 11
6.2 Utilisation d'une nomenclature. 12
6.3 Définitions de classes d'objets personnels de santé . 13
6.3.1 Généralités . 13
6.3.2 Classe de système MDS . 15
6.3.3 Classe Metric (mesure) . 22
6.3.4 Classe Numeric (numérique). 26
6.3.5 Classe RT-SA . 29
6.3.6 Classe d'énumération . 30
6.3.7 Classe PM-store. 32
6.3.8 Classe PM-segment. 37
6.3.9 Classes d'analyseurs . 40
6.4 Règles d'extensibilité de modèle d'informations. 49
7. Modèle de service de dispositif personnel de santé . 50
7.1 Généralités. 50
7.2 Service association. 50
7.3 Services d'accès d'objets. 50
7.4 Application spécifique de services EVENT REPORT d'accès à des objets pour les
dispositifs personnels de santé . 51
7.4.1 Généralités . 51
7.4.2 Les rapports d'événements confirmés et non confirmés . 51
7.4.3 Rapport d'événement de configuration. 51
7.4.4 Transmission de données de mesure initiée par l'agent et le gestionnaire. 54
7.4.5 Rapports d'événements à formats variables, fixes et regroupés. 54
7.4.6 Rapports d'événements d'une personne unique et de plusieurs personnes . 55
7.4.7 Mesurage mémorisé temporairement. 57
8. Modèle de communication . 57
8.1 Généralités. 57
8.2 Contexte du système. 58
8.3 Caractéristiques de communications. 59
8.3.1 Généralités . 59
8.3.2 Caractéristiques communes de communications . 61
8.3.3 Caractéristiques des communications fiables . 61
8.3.4 Caractéristiques de communications du type au mieux. 62
© IEEE 2010 – Tous droits réservés iii
8.4 Machines à états finis. 62
8.4.1 Machine à états finis d'un agent . 62
8.4.2 Machine à états finis du gestionnaire. 66
8.4.3 Variables de temps imparti. 68
8.5 Procédure «Connecté». 68
8.5.1 Généralités . 68
8.5.2 Conditions d'entrée . 69
8.5.3 Procédures normales. 69
8.5.4 Conditions de sortie. 69
8.5.5 Conditions d'erreur . 69
8.6 Procédure à l'état Unassociated (non associé) . 69
8.6.1 Généralités . 69
8.6.2 Conditions d'entrée . 69
8.6.3 Procédures normales. 69
8.6.4 Conditions de sortie. 70
8.6.5 Conditions d'erreur . 70
8.7 Procédure d'établissement d'une association. 70
8.7.1 Généralités . 70
8.7.2 Conditions d'entrée . 70
8.7.3 Procédures normales. 70
8.7.4 Conditions de sortie. 75
8.7.5 Conditions d'erreur . 75
8.7.6 Association pour un test . 75
8.8 Procédure de configuration . 76
8.8.1 Généralités . 76
8.8.2 Conditions d'entrée . 76
8.8.3 Procédures normales. 77
8.8.4 Conditions de sortie. 79
8.8.5 Conditions d'erreur . 80
8.9 Procédure pour l'état Operating (fonctionnement). 80
8.9.1 Généralités . 80
8.9.2 Conditions d'entrée . 80
8.9.3 Procédures normales. 80
8.9.4 Conditions de sortie. 94
8.9.5 Conditions d'erreur . 94
8.10 Procédure pour mettre fin à une association . 96
8.10.1 Généralités . 96
8.10.2 Conditions d'entrée . 96
8.10.3 Procédures normales. 96
8.10.4 Conditions de sortie. 97
8.10.5 Conditions d'erreur . 97
8.11 Codage de message . 97
8.12 Coordination du temps. 97
8.12.1 Généralités . 97
8.12.2 Temps absolu. 98
8.12.3 Temps relatif . 99
8.12.4 Temps relatif à haute résolution . 100
9. Modèle de conformité . 100
9.1 Applicabilité. 100
9.2 Les spécifications de la conformité. 101
9.3 Déclarations de conformité de réalisation (ICS). 101
9.4 Conformité générale . 102
9.4.1 Déclaration ICS générale . 102
9.4.2 Déclaration ICS d'exigences minimales. 104
9.4.3 Déclaration ICS de prise en charge de services . 105
9.5 Déclaration ICS relative aux additions/extensions de dispositifs . 107
9.5.1 Déclaration ICS générale relative aux additions/extensions . 107
9.5.2 Déclaration ICS relative à l'objet et la classe de modèle DIM d'un dispositif
personnel de santé (POC). 108
iv © IEEE 2010 – Tous droits réservés
9.5.3 Déclaration ICS d'attributs POC. 108
9.5.4 Déclaration ICS de comportement POC. 109
9.5.5 Déclaration ICS de notifications POC. 110
9.5.6 Déclaration ICS de nomenclatures POC . 110
Annexe A (normative) Définitions ASN.1 . 111
Annexe B (informative) Exemple de spécification d'échelle et de plage . 145
Annexe C (informative) Concept de mémoire PM-store. 147
Annexe D (informative) Types de profils de transport. 153
Annexe E (normative) Tables d'état. 156
Annexe G (informative) Définitions des types de données codés. 185
Annexe H (informative) Exemples. 204
Annexe I (normative) Codes de nomenclature . 211
Annexe J (informative) Détermination et historique des modifications. 215
Annexe K (informative) Bibliographie. 218
© IEEE 2010 – Tous droits réservés v
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 11073-20601 a été élaborée par le Comité 11073 de la Société d'Ingénierie en Médecine
et Biologie de l'IEEE (en tant que norme IEEE 11073-20601:2008). 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
vi © IEEE 2010 – Tous droits réservés
⎯ 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
© IEEE 2010 – Tous droits réservés vii
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)
l'IEEE 11073-20601 et décrit une approche de communication interopérable spécifique pour les
moniteurs de pression sanguine. 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.
Le présent document traite du besoin d'une norme indépendante, ouvertement définie pour convertir
les informations récoltées en un format de transmission interopérable; ainsi les informations peuvent
être échangées entre agents et gestionnaires.
D'autres normes relativement proches incluent les suivantes:
2)
⎯ l'ISO/IEEE 11073-00103 [B8] donne un aperçu global de l'espace de santé personnel et
définit des cas d'utilisation et des modèles d'utilisation sous-jacents.
⎯ l'ISO/IEEE 11073-10101 [B12] documente les termes de la nomenclature qui peuvent être
utilisés.
⎯ l'ISO/IEEE 11073-10201:2004 [B13] documente le modèle d'informations du domaine (DIM)
soulevé par la présente norme.
⎯ les normes ISO/IEEE 11073-104zz définissent les spécialisations d'un dispositif spécifique. Par
exemple, l'ISO/IEEE 11073-10404 [B9] définit comment fonctionnent les oxymètres de pouls
interopérables.
⎯ l'ISO/IEEE 11073-20101:2004 [B14] définit les règles de codage de dispositif médical (MDER)
appuyées dans la présente norme.
1)
Pour des informations sur les références, se reporter à l'Article 2.
2)
La numérotation entre crochets correspond à la numérotation de la Bibliographie donnée dans l'Annexe K.
viii © IEEE 2010 – Tous droits réservés
NORME INTERNATIONALE ISO/IEEE 11073-20601:2010(F)
Informatique de santé — Communication entre dispositifs
de santé personnels —
Partie 20601:
Profil d'application — Protocole d'échange optimisé
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
rédacteurs de 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 générale
1.1 Domaine d'application
Dans le contexte de la famille de norme ISO/IEEE 11073 relative à la communication entre
dispositifs, la présente norme définit un cadre commun, pour rendre disponible un modèle abstrait
de données relatives à la santé personnelle dans une syntaxe de transfert indépendante du
transport requise pour établir des connexions logiques entre systèmes et pour fournir des capacités
et des services de présentation nécessaires pour effectuer les tâches de communication. Le
protocole est optimisé pour répondre aux exigences des utilisations relatives à la santé des
personnes et s'appuie dans la mesure du possible sur des méthodes et des outils couramment
utilisés.
1.2 Objet
Le présent document répond à la nécessité d'une norme indépendante définie de manière ouverte
permettant de convertir le profil d'information en informant les transmissions internes opérables de
sorte que les informations puissent être transmises vers des dispositifs personnels de télésanté et
des moteurs informatiques (par exemple des téléphones cellulaires, des ordinateurs personnels, des
appareils personnels de santé et des boîtiers décodeurs) et depuis ceux-ci.
© IEEE 2010 – Tous droits réservés 1
1.3 Contexte
La Figure 1 représente des catégories et des dispositifs caractéristiques prenant en charge
l'espace de santé personnelle. Les agents (par exemple les dispositifs de surveillance de la
pression sanguine, des balances et des podomètres) recueillent des informations sur une
personne (ou des personnes) et transfèrent les informations à un gestionnaire (par exemple un
téléphone cellulaire, un appareil de santé ou un ordinateur personnel) en vue de leur recueil,
affichage et d'une éventuelle transmission ultérieure. Le gestionnaire peut également transférer
les données à des services de support à distance en vue d'une analyse ultérieure. Les
informations disponibles proviennent d'un ensemble de domaines, comprenant des applications
de gestion des maladies, de santé et de mise en forme ou de vieillissement indépendantes.
Le trajet des communications entre l'agent et le gestionnaire est supposé être une connexion
logique de point à point. En général, un agent communique avec un seul gestionnaire à un instant
donné. Un gestionnaire peut communiquer avec de multiples agents simultanément en utilisant
des connexions séparées de point à point.
La zone en recouvrement indique le domaine sur lequel se concentre le groupe de travail IEEE
11073™ Personal Health Devices Working Group. Le sujet principal d'intérêt est l'interface et
l'échange des données entre les agents et le gestionnaire. Cependant, cette interface ne peut pas
être créée de manière isolée en ignorant le reste de l'espace de solution. Le fait de rester informé
du système entier contribue à garantir que les données peuvent raisonnablement partir des
agents et remonter sur la totalité du chemin jusqu'aux services de support à distance lorsque cela
est nécessaire. Ce trajet peut inclure la conversion du format des données, des protocoles
d'échange et des protocoles de transport à travers les différentes interfaces. Une grande partie de
l'effort de normalisation est en dehors du mandat du groupe de travail Personal Health Devices
Working Group. Cependant, le fait d'aligner tous les efforts de normalisation permet que les
données circulent de manière transparente à travers l'ensemble global de systèmes.
2 © IEEE 2010 – Tous droits réservés
Légende
Disease Mgmt Gestion des maladies
Diet Service Service de régime
Fitness Service Service de mise en forme
Aging service Service de vieillissement
Remote Support services Services de support à distance
Personal Computer Ordinateur personnel
Cell Phone Téléphone cellulaire
Health Appliance Appareil de santé
Set Top Box Boîtier décodeur
Manager Devices Dispositifs gestionnaires
IEEE 11073 Personal Health Device Primary Domaine d'intérêt du groupe de travail Personal Health
Focus Area Device de l'IEEE 11073
Agent Devices Dispositifs agents
Treadmill Tapis roulant
Weighing Scale Balance
Activity Monitor Dispositif de surveillance d'activité
Blood Pressure Monitor Dispositif de surveillance de pression sanguine
Figure 1 — Contexte global des travaux
© IEEE 2010 – Tous droits réservés 3
La Figure 2 représente une vue hiérarchique de l'architecture d'un agent ou d'un gestionnaire
superposée avec une vue des normes apparentées. Les couches d'application ne sont pas, pour
la plus grande partie, spécifiques d'un mode de transport particulier. Lorsque cela est nécessaire,
la norme identifie les hypothèses qui requièrent une prise en charge directe par une couche de
transport ou une couche de «calage» au-dessus de la couche de transport. Cette approche
permet la prise en charge de divers modes de transport. La définition des transports est en dehors
du domaine d'application de la présente norme et du mandat du groupe de travail.
Au-dessus de la couche de transport se trouve le Protocole d'Échange Optimisé (décrit dans la
présente norme). Ce protocole est constitué de deux volets : les services des couches
d'application et la définition du protocole d'échange de données entre les agents et les
gestionnaires. Les services des couches d'application fournissent le protocole pour la gestion de
la connexion et le transfert fiable d'actions et de données entre l'agent et le gestionnaire. Le
protocole d'échange de données définit les commandes, les informations de configuration d'agent,
le format des données et le protocole global. Le Protocole d'Échange Optimisé fournit la base
pour la prise en charge de tout type d'agent. Pour un type spécifique de dispositif, le lecteur est
renvoyé à la spécialisation du dispositif pour cet agent afin de comprendre les capacités du
dispositif et sa mise en œuvre conformément à la présente norme. La spécialisation du dispositif
indique les aspects de la présente norme à comprendre et l'endroit où trouver les informations
pour mettre en œuvre le dispositif.
Au-dessus du protocole d'échange se trouvent les spécialisations de dispositifs, qui décrivent les
détails spécifiques relatifs à l'agent particulier (par exemple un dispositif de surveillance de
pression sanguine, une balance ou un podomètre). Les spécialisations décrivent en détails la
manière dont ces agents travaillent et agissent sous la forme d'une description détaillée afin de
créer un type spécifique d'agent. En outre, elles fournissent des références à une norme associée
en ce qui concerne les détails supplémentaires. Les numéros de normes réservées pour les
spécialisations de dispositifs vont de l'IEEE 11073-10401 à l'IEEE 11073-10499, inclus. Lorsqu'il
est fait référence à l'ensemble des normes, le terme IEEE 11073-104zz est utilisé, où zz pourrait
être tout nombre dans la plage de 01 à 99, inclus.
3)
Le rapport technique ISO/IEEE 11073-00103 [B8] décrit l'espace global de santé personnelle
avec une définition supplémentaire des cas d'utilisation et des modèles d'utilisation sous-jacents.
3)
La numérotation entre crochets correspond à la numérotation de la Bibliographie donnée dans l'Annexe K.
4 © IEEE 2010 – Tous droits réservés
Légende
-00103 Technical Report – Overview Rapport Technique 00103 – Description générale
Device Specializations Spécialisations de dispositifs
-10404 Pulse Oximeter -10404 Oxymètre de pouls
-10407 Blood Pressure -10407 Pression sanguine
-10408 Thermometer -10408 Thermomètre
-10415 Weighing Scale -10415 Balance
-10417 Glucose -10417 Glucose
-10441 H&F -10441 Santé et mise en forme
Cardio/Strengh Rythme cardiaque/Résistance
-10471 Activity Hub -10471 Concentrateur d'activités
Phase II Phase II
-20601 Optimized Exchange Protocol -20601 Protocole d'échange optimisé
Transports Transports
Figure 2 — Carte de documents
Les spécialisations de dispositifs personnels de santé ne sont pas créées indépendamment de
toutes les autres normes. Il existe un certain nombre de normes existantes générées pour les
environnements cliniques dont s'inspirent ces normes. La Figure 3 indique la relation avec le reste
des documents de l'IEEE 11073. Il existe deux types de relations:
– S'inspirer des idées et/ou du contenu des autres documents (lignes à traits interrompus)
– S'appuyer sur les informations provenant d'un autre document et introduire le nouveau contenu
dans ce document pour pouvoir appuyer la présente norme (ligne à traits continus)
La présente norme importe des informations de l'ISO/IEEE 11073-10201:2004 [B13] et de
l'ISO/IEEE 11073–20101:2004 [B14] en tant qu'annexes normatives. S'il existe une différence entre
ces normes, la présente norme a priorité. Du fait de la réutilisation de concepts de ces normes,
certains des noms apparaissent se rapporter davantage au domaine clinique [par exemple système
de dispositif médical (MDS) au lieu de système de dispositif personnel de santé]. Cependant, pour
maintenir la cohérence, les noms traditionnels ont été conservés.
La présente norme reproduit des parties appropriées de l'ISO/IEEE 11073-10101 [B12] et
incorpore de nouveaux codes de nomenclature.
© IEEE 2010 – Tous droits réservés 5
Légende
Device specializations Spécialisations de dispositifs
-10304 Pulse Oximeter -10304 Oxymètre de pouls
-10307 Blood Pressure -10307 Pression sanguine
-10306 Pulse -10306 Pouls
-10315 Weighing Scale -10315 Balance
-10308 Thermometer -10308 Thermomètre
-10101 Nomenclature -10101 Nomenclature
-10201 Domain Information Model -10201 Modèle d'informations du domaine
-20101 Application Profiles – Base -20101 Profils d'application - Base
MDER MDER
-00103 Technical Report – - Rapport Technique 00103 – Description générale
Overview
Device Specializations Spécialisations de dispositifs
-10404 Pulse Oximeter -10404 Oxymètre de pouls
-10407 Blood Pressure -10407 Pression sanguine
-10408 Thermometer -10408 Thermomètre
-10415 Weighing Scale -10415 Balance
-10417 Glucose -10417 Glucose
-10441/-10442 H&F -10441/-10442 Hygiène et Remise en forme
Cardio/Strengh Rythme cardiaque/Résistance
-10471 Activity Hub -10471 Concentrateur d'activités
Phase II Phase II
-20601 Optimal Exchange Protocol -20601 Protocole d'Échange Optimisé
Transports Transports
-30200 Serial -30200 Série
-30300 IrDA -30300 IrDA
Figure 3 — Relation avec d'autres documents de l'IEEE 11073
6 © IEEE 2010 – Tous droits réservés
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 802-2001, norme IEEE pour les réseaux locaux et dans les zones métropolitaines:
4)
Description et Architecture
ITU-T Rec. X.667 (Sept. 2004), Technologie de l'information — Interconnexion de systèmes
ouverts — Procédures pour la mise en œuvre d'autorités d'enregistrement OSI: Génération et
enregistrement d'identificateurs uniques universels (UUID) et leur utilisation comme composants
5)
d'identificateurs d'objets en notation ASN.1
3. Définitions, acronymes et abréviations
3.1 Définitions
Pour les besoins de la présente norme, les termes et définitions suivants s'appliquent. Il convient
de faire référence au dictionnaire «The Authoritative Dictionary of IEEE Standards Terms [B6]»
pour les termes qui ne sont pas définis dans le présent Article.
3.1.1 agent: nœud qui collecte et transmet des données de santé personnelles à un gestionnaire
associé
3.1.2 moteur informatique: voir gestionnaire.
3.1.3 confirmé: mécanisme de services de notification d'achèvement, au niveau de l'application.
Pour les services du type EVENT REPORT (c'est-à-dire le plan de données), une confirmation
permet à l'agent de savoir quand le gestionnaire a «accepté la responsabilité» d'un élément de
données de sorte que l'agent peut supprimer ces données. Pour les services ACTION, GET et
SET (c'est-à-dire le plan de commande), la confirmation permet que l'agent sache quand l'agent a
«achevé» la transaction demandée.
3.1.4 dispositif: dispositif physique jouant le rôle soit d'un agent, soit d'un gestionnaire
3.1.5 poignée: nombre de 16-bits sans signe qui est localement unique et identifie l'une des
instances d'objet au sein d'un agent
3.1.6 gestionnaire: nœud recevant des données d'un ou plusieurs systèmes agents. Des
exemples de gestionnaires incluent un téléphone cellulaire, un appareil de santé, un boîtier
décodeur ou un système informatique
3.1.7 dispositif personnel de santé: dispositif utilisé dans des applications personnelles de santé
3.1.8 dispositif personnel de télésanté: voir dispositif personnel de santé.
4)
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/).
5)
Les publications de l'UIT-T sont disponibles auprès de l'Union Internationale des Télécommunications, place
des Nations, CH-1211 Genève 20, Switzerland/Suisse (http://www.itu.int/).
© IEEE 2010 – Tous droits réservés 7
3.2 Acronymes et abréviations
6)
ASCII
Code Normalisé Américain pour l'échange mutuel d'informations
ASN. 1 Notation de Syntaxe Abstraite numéro 1
APDU Unité de données de protocole d'application
AVA assertion de valeur d'attribut
BER règles de codage binaire
DIM modèle d'informations du domaine
EUI-64 identificateur unique étendu (64 bits)
GMDN nomenclature de dispositif médical globale
ICS déclaration de conformité de réalisation
ID identificateur
LSB bit le moins significatif
MDER règles de codage des dispositifs médicaux
MDNF format numérique de dispositif médical
MDS système de dispositif médical
MOC classe d'objet médical
MSB bit le plus significatif
NaN pas un nombre
NBO ordre d'octet dans le réseau
NRes pas à cette résolution
NTP protocole de temps de réseau
OID identificateur d'objet
OUI identificateur unique au plan organisationnel
PDU unité de données de protocole
PER règles de codage conditionnées
POC objet et classe de modèle d'informations du domaine de dispositif personnel de
santé
RCassoc comptage de réessai: procédure d'association
RTC horloge en temps réel
RT-SA groupement d'échantillons en temps réel
SNTP Simple Network Time Protocol (Protocole Simple de Temps de Réseau)
TCP protocole de commande de transmission
TOassoc dépassement de temps imparti : procédure d'association
TO dépassement de temps imparti : service d'action confirmé
ca
TOcer-mds dépassement de temps imparti : service de rapport d'événement confirmé pour
l'objet MDS
TOclr-pms dépassement de temps imparti : service de rapport d'événement confirmé pour
l'objet PM-store
TO dépassement de temps imparti: service de rapport d'événement confirmé pour
cer-scan
l'objet analyseur
TOclr-pms dépassement de temps imparti: service d'action confirmé pour effacer l'objet
PM-store
TOconfig dépassement de temps imparti : procédure de configuration
TOcs dépassement de temps imparti : service SET confirmé
TOget dépassement de temps imparti: service GET
TOrelease dépassement de temps imparti : procédure de libération d'association
TOsp-mds dépassement de temps imparti : dépassement de temps imparti de service
mutuel spécial pour l'objet MDS
TO dépassement de temps imparti: dépassement de temps imparti de transfert de
sp-pms
segment spécial pour l'objet PM-segment
UTC temps universel coordonné
UUID identificateur unique universel
USB universal serial bus (bus série universel)
XER règles de codage en langage de balisage extensible (XML)
6)
Noter que dans toute la présente Norme, le terme ASCII est utilisé pour désigner l'ensemble des caractères
comme défini dans l'ISO/CEI 646 (1991) [B7].
8 © IEEE 2010 – Tous droits réservés
4. Principes directeurs
La présente norme et les autres normes relatives aux dispositifs de santé s'intègrent dans le
contexte plus large de la famille de normes ISO/IEEE 11073. L'ensemble complet de normes
permet aux agents de s'interconnecter et d'opérer mutuellement avec les gestionnaires et avec
des systèmes informatisés d'information de soins.
Le profil de communication défini dans la présente norme prend en compte les exigences
spécifiques des agents et des gestionnaires de santé personnelle, qui sont habituellement
utilisées en dehors d'un environnement clinique, par exemple qui sont mobiles ou qui se trouvent
au domicile d'une personne:
– Les agents personnels de santé ont habituellement des capacités informatiques très l
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