ISO/IEEE 11073-10207:2019

Health informatics — Personal health device communication — Part 10207: Domain information and service model for service-oriented point-of-care medical device communication

The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked point-of-care medical devices need to be controlled. The standard provides a Participant Model and Communication Model derived from the IEEE 11073? Domain Information Model (IEEE 11073-10201? DIM). Furthermore, it utilizes the IEEE 11073 Nomenclature (IEEE 11073-10101?) and supports other coding systems to convey the semantics of any information elements.[1] The definition of network transport mechanisms is outside the scope of this standard. [1] Information on normative references can be found in Clause 2.

Informatique de santé — Communication entre dispositifs de santé personnels — Partie 10207: Informations de domaine et modèle de services pour la communication orientée services entre dispositifs médicaux sur le site des soins

General Information

• Status: Published
• Publication Date: 07-Mar-2019
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 9093 - International Standard confirmed
• Start Date: 26-Aug-2024
• Completion Date: 14-Feb-2026

Overview

ISO/IEEE 11073-10207:2019 - "Health informatics - Personal health device communication - Part 10207" defines a domain information and service model for service-oriented, point-of-care medical device communication. The standard specifies how medical information objects are structured and exchanged in distributed systems of point-of-care devices and medical IT systems. It provides a Participant Model derived from the IEEE 11073 Domain Information Model (IEEE 11073-10201) and an abstract Communication Model; all model elements are expressed using XML Schema. Network transport mechanisms are intentionally outside the scope.

Key topics

• Participant Model: structure and semantics for medical information objects (measurements, device settings, alerts, contextual data such as patient demographics and location, remote control and archival data).
• Communication Model: abstract, service-oriented framework to support exchange and management of the Participant Model objects.
• Data semantics: use of IEEE 11073 Nomenclature (IEEE 11073-10101) and support for other coding systems to convey meaning.
• XML Schema: formal specification of all model elements enabling implementation, validation and extensibility.
• Extensibility & interoperability: model designed to be extended via XML Schema while maintaining semantic interoperability across devices and systems.
• Scope limits: defines information models and services; does not define specific network transport protocols.

Applications

ISO/IEEE 11073-10207:2019 is targeted at systems and implementations requiring standardized, service-oriented point-of-care device information exchange:

• Real-time vital signs capture and electronic data capture at the bedside
• Clinical device networks in hospitals, ambulatory clinics and remote monitoring environments
• Integration of bedside monitors, infusion pumps, wearable personal health devices and EHR/medical IT systems
• Implementation of device remote-control services, alerting and archival of device and patient data
• Enabling plug-and-play interoperability for multi-vendor device ecosystems

Who uses this standard

• Medical device manufacturers implementing interoperable device data models
• Healthcare IT vendors and EHR integrators integrating point-of-care data flows
• System architects and engineers designing service-oriented medical device networks
• Clinical engineers and hospitals planning device integration and data capture
• Standards developers and testing bodies validating conformance to IEEE 11073 models

Related standards

• IEEE 11073-10201 - Domain Information Model (source of the Participant Model)
• IEEE 11073-10101 - Nomenclature (coding of medical concepts)
• Other parts of the ISO/IEEE 11073 series covering device communication profiles and transports

Keywords: ISO/IEEE 11073-10207:2019, health informatics, personal health device communication, point-of-care, Participant Model, Communication Model, XML Schema, IEEE 11073, service-oriented architecture, medical device interoperability.

Standards Content (Sample)

ISO/IEEE
INTERNATIONAL
11073-10207
STANDARD
First edition
2019-03
Health informatics — Personal health
device communication —
Part 10207:
Domain information and service
model for service-oriented point-of-
care medical device communication
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10207: Informations de domaine et modèle de services pour la
communication orientée services entre dispositifs médicaux sur le site
des soins
Reference number
©
IEEE 2018
© IEEE 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: [e-mail]
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2018 – All rights reserved

Foreword
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ISO/IEEE 11073-10207 was prepared by the IEEE 11073 Standards Committee of the IEEE
Engineering in Medicine and Biology Society (as IEEE Std 11073-10207-2017) and drafted in
accordance with its editorial rules. It was adopted, under the “fast-track procedure” defined in the
Partner Standards Development Organization cooperation agreement between ISO and IEEE, by
Technical Committee ISO/TC 215, Health informatics.
A list of all parts in the ISO 11073 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards
body. A complete listing of these bodies can be found at www.iso.org/members.html.
© IEEE 2018 – All rights reserved
iii
Abstract: Within the context of the ISO/IEEE 11073™ family of standards for point-of-care
medical device communication, a Participant Model derived from the ISO/IEEE11073-10201
Domain Information Model is provided in this standard. The Participant Model specifies the
structure of medical information objects. This standard also defines an abstract Communication
Model to support the exchange of medical information objects. All elements of the Participant
Model and Communication Model are specified using XML Schema. Core subjects of the
Participant Model comprise modelling of medical device-related data, e.g., measurements and
settings, alert systems, contextual information (e.g., patient demographics and location
information), remote control, and archival information. Model extensibility is provided inherently
through the use of XML Schema.
Keywords: alert systems, IEEE 11073-10207™, medical device communication, patient, point-
of-care, remote control, service-oriented architecture, XML Schema
•
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Participants
At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Point of Care
Devices Working Group had the following membership:
Jan Wittenber, Chair
Stefan Schlichting, Subgroup Chair
Bjoern Anderson Frank Golatowski Stephan Poehlsen
Malcolm Clarke David Gregorczyk Tracy Rausch
Todd Cooper Kai Hassing John Rhoads
Chris Courville John Hatcliff Paul Schluter
Michael Faughn Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Joerg-Uwe Meyer
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen David Gregorczyk Martin Kasparick
Susan Burgess Randall Groves Joerg-Uwe Meyer
Craig Carlson Kai Hassing Stephan Poehlsen
Keith Chow Robert Heile Beth Pumo
Malcolm Clarke Werner Hoelzl Stefan Schlichting
Todd Cooper Noriyuki Ikeuchi Eugene Stoudenmire
Sourav Dutta Atsushi Ito Walter Struppler
Kenneth Fuchs Stefan Karl J. Wiley
Joel Goergen Piotr Karocki Jan Wittenber
Frank Golatowski Oren Yuen
When the IEEE-SA Standards Board approved this standard on 6 December 2017, it had the following
membership:
Jean-Philippe Faure, Chair
Gary Hoffman, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Chuck Adams
Thomas Kochy Robby Robson
Masayuki Ariyoshi Joseph L. Koepfinger* Dorothy Stanley
Ted Burse Kevin Lu Adrian Stephens
Stephen Dukes Daleep Mohla Mehmet Ulema
Doug Edwards Damir Novosel Phil Wennblom
J. Travis Griffith Ronald C. Petersen Howard Wolfman
Michael Janezic Annette D. Reilly Yu Yuan
*Member Emeritus
Introduction
This introduction is not part of IEEE Std 11073-10207-2017, Health informatics—Point-of-care medical device
communication—Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical
Device Communication.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
systems. They provide automatic and detailed electronic data capture of patient vital signs information and
device operational data. The primary goals of these standards are to
 Provide real-time, plug-and-play interoperability for patient-connected medical devices.
 Facilitate the efficient exchange of vital signs and medical device data, acquired at the point of
care, in all health care environments.
“Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or
processed in fractions of a second. “Plug-and-play” means that all the clinician has to do is make the
connection—the systems automatically detect, configure, and communicate without any other human
interaction.
“Efficient exchange of medical device data” means that information that is captured at the point of care
(e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of
applications without extensive software and equipment support and without needless loss of information.
The standards are especially targeted at acute and continuing care devices, such as patient monitors,
ventilators, infusion pumps, and electrocardiogram (EKG) devices. This family of standards can be layered
together to provide connectivity optimized for the specific devices being interfaced.
Note that normative statements of requirements are presented in this standard in the following manner:
Rnnnn: Statement text here.
where "nnnn" is replaced by a number that is unique among the requirements in this standard and thereby
forms a unique requirement identifier, for example,
R0007: All HANDLEs SHALL be unique within one MDIB sequence of a SERVICE PROVIDER.

Contents
1. Overview .21
1.1 Scope .21
1.2 Purpose .21
2. Normative references .22
3. Definitions and notational conventions .23
3.1 Definitions .23
3.2 Notational conventions .25
4. Introduction to BICEPS .28
5. Participant Model .30
5.1 Overview .30
5.2 Background .30
5.3 Descriptive part.34
5.4 State part .41
6. Alert signal delegation .49
6.1 General .49
6.2 Delegable alert signals .49
6.3 Fallback alert signals .52
7. Communication Model .53
7.1 General .53
7.2 Message exchange patterns .53
7.3 Service Model .54
7.4 Message Model .59
8. Extension Model .62
9. Discovery Model .63
9.1 General .63
9.2 Implicit discovery .63
9.3 Explicit discovery .63
10. Nonfunctional requirements .64
10.1 General .64
10.2 Patient safety considerations .64
10.3 Cybersecurity considerations .64
10.4 Clinical effectiveness .65
10.5 Regulatory considerations .65
11. Conformance .66
11.1 Overview .66
11.2 General format .66
11.3 ICS tables .67
Annex A (normative) Extension Model .70
A.1 Extension .70
A.2 ExtensionType .71

A.3 MustUnderstand .71
Annex B (normative) Participant Model .72
B.1 AbstractAlertDescriptor .74
B.2 AbstractAlertState .74
B.3 AbstractAlertState/@ActivationState .75
B.4 AbstractComplexDeviceComponentDescriptor .75
B.5 AbstractComplexDeviceComponentDescriptor/AlertSystem .76
B.6 AbstractComplexDeviceComponentDescriptor/Sco .77
B.7 AbstractComplexDeviceComponentState .78
B.8 AbstractContextDescriptor .79
B.9 AbstractContextState .80
B.10 AbstractContextState/@ContextAssociation .81
B.11 AbstractContextState/@BindingMdibVersion .81
B.12 AbstractContextState/@UnbindingMdibVersion.81
B.13 AbstractContextState/@BindingStartTime .82
B.14 AbstractContextState/@BindingEndTime .82
B.15 AbstractContextState/Validator .82
B.16 AbstractContextState/Identification .83
B.17 AbstractDescriptor .83
B.18 AbstractDescriptor/@Handle .84
B.19 AbstractDescriptor/@DescriptorVersion .84
B.20 AbstractDescriptor/@SafetyClassification .84
B.21 AbstractDescriptor/Type .85
B.22 AbstractDeviceComponentDescriptor .86
B.23 AbstractDeviceComponentDescriptor/ProductionSpecification .86
B.24 AbstractDeviceComponentDescriptor/ProductionSpecification/SpecType .87
B.25 AbstractDeviceComponentDescriptor/ProductionSpecification/ ProductionSpec .88
B.26 AbstractDeviceComponentDescriptor/ProductionSpecification/ComponentId .88
B.27 AbstractDeviceComponentState .89
B.28 AbstractDeviceComponentState/@ActivationState .90
B.29 AbstractDeviceComponentState/@OperatingHours .90
B.30 AbstractDeviceComponentState/@OperatingCycles .90
B.31 AbstractDeviceComponentState/CalibrationInfo .90
B.32 AbstractDeviceComponentState/NextCalibration.91
B.33 AbstractDeviceComponentState/PhysicalConnector .92
B.34 AbstractMetricDescriptor .93
B.35 AbstractMetricDescriptor/@MetricCategory .94
B.36 AbstractMetricDescriptor/@DerivationMethod.94
B.37 AbstractMetricDescriptor/@MetricAvailability .95
B.38 AbstractMetricDescriptor/@MaxMeasurementTime .95
B.39 AbstractMetricDescriptor/@MaxDelayTime .95
B.40 AbstractMetricDescriptor/@DeterminationPeriod.96
B.41 AbstractMetricDescriptor/@LifeTimePeriod .96
B.42 AbstractMetricDescriptor/@ActivationDuration .96
B.43 AbstractMetricDescriptor/Unit .97
B.44 AbstractMetricDescriptor/BodySite .98
B.45 AbstractMetricDescriptor/Relation .99
B.46 AbstractMetricDescriptor/Relation/@Kind .100
B.47 AbstractMetricDescriptor/Relation/@Entries .100
B.48 AbstractMetricDescriptor/Relation/Code .101
B.49 AbstractMetricDescriptor/Relation/Identification .102
B.50 AbstractMetricState .103
B.51 AbstractMetricState/@ActivationState .104
B.52 AbstractMetricState/@ActiveDeterminationPeriod .104
B.53 AbstractMetricState/@LifeTimePeriod .104

B.54 AbstractMetricState/BodySite.105
B.55 AbstractMetricState/PhysicalConnector .106
B.56 AbstractMetricValue .106
B.57 AbstractMetricValue/@StartTime .107
B.58 AbstractMetricValue/@StopTime .107
B.59 AbstractMetricValue/@DeterminationTime .107
B.60 AbstractMetricValue/MetricQuality .107
B.61 AbstractMetricValue/MetricQuality/@Validity.108
B.62 AbstractMetricValue/MetricQuality/@Mode .108
B.63 AbstractMetricValue/MetricQuality/@Qi .108
B.64 AbstractMetricValue/Annotation .109
B.65 AbstractMetricValue/Annotation/Type .109
B.66 AbstractMultiState .110
B.67 AbstractMultiState/@Handle .111
B.68 AbstractMultiState/Category .111
B.69 AbstractOperationDescriptor .112
B.70 AbstractOperationDescriptor/@OperationTarget .113
B.71 AbstractOperationDescriptor/@MaxTimeToFinish.113
B.72 AbstractOperationDescriptor/@InvocationEffectiveTimeout .113
B.73 AbstractOperationDescriptor/@Retriggerable .113
B.74 AbstractOperationDescriptor/@AccessLevel .114
B.75 AbstractOperationState .114
B.76 AbstractOperationState/@OperatingMode .115
B.77 AbstractSetStateOperationDescriptor .115
B.78 AbstractSetStateOperationDescriptor/ModifiableData .116
B.79 AbstractState .116
B.80 AbstractState/@StateVersion .117
B.81 AbstractState/@DescriptorHandle .117
B.82 AbstractState/@DescriptorVersion .117
B.83 ActivateOperationDescriptor .118
B.84 ActivateOperationDescriptor/Argument .119
B.85 ActivateOperationDescriptor/Argument/ArgName .119
B.86 ActivateOperationDescriptor/Argument/Arg .120
B.87 ActivateOperationState .120
B.88 AlertConditionDescriptor .121
B.89 AlertConditionDescriptor/@Kind .122
B.90 AlertConditionDescriptor/@Priority .122
B.91 AlertConditionDescriptor/@DefaultConditionGenerationDelay .122
B.92 AlertConditionDescriptor/@CanEscalate .122
B.93 AlertConditionDescriptor/@CanDeescalate .123
B.94 AlertConditionDescriptor/Source .123
B.95 AlertConditionDescriptor/CauseInfo .123
B.96 AlertConditionState .124
B.97 AlertConditionState/@ActualConditionGenerationDelay .125
B.98 AlertConditionState/@ActualPriority .125
B.99 AlertConditionState/@Rank .125
B.100 AlertConditionState/@Presence .125
B.101 AlertConditionState/@DeterminationTime .125
B.102 AlertSignalDescriptor .126
B.103 AlertSignalDescriptor/@ConditionSignaled .127
B.104 AlertSignalDescriptor/@Manifestation.127
B.105 AlertSignalDescriptor/@Latching .128
B.106 AlertSignalDescriptor/@DefaultSignalGenerationDelay .128
B.107 AlertSignalDescriptor/@MinSignalGenerationDelay .128
B.108 AlertSignalDescriptor/@MaxSignalGenerationDelay .128
B.109 AlertSignalDescriptor/@SignalDelegationSupported .128

B.110 AlertSignalDescriptor/@AcknowledgementSupported .128
B.111 AlertSignalDescriptor/@AcknowledgeTimeout .129
B.112 AlertSignalState .129
B.113 AlertSignalState/@ActualSignalGenerationDelay .130
B.114 AlertSignalState/@Presence .130
B.115 AlertSignalState/@Location .130
B.116 AlertSignalState/@Slot .130
B.117 AlertSystemDescriptor .131
B.118 AlertSystemDescriptor/@MaxPhysiologicalParallelAlarms .132
B.119 AlertSystemDescriptor/@MaxTechnicalParallelAlarms .132
B.120 AlertSystemDescriptor/@SelfCheckPeriod .132
B.121 AlertSystemDescriptor/AlertCondition .132
B.122 AlertSystemDescriptor/AlertSignal .133
B.123 AlertSystemState .134
B.124 AlertSystemState/@LastSelfCheck .
...

ISO/IEEE
INTERNATIONAL
11073-10207
STANDARD
First edition
2019-03
Health informatics — Personal health
device communication —
Part 10207:
Domain information and service
model for service-oriented point-of-
care medical device communication
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10207: Informations de domaine et modèle de services pour la
communication orientée services entre dispositifs médicaux sur le site
des soins
Reference number
©
IEEE 2018
© IEEE 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: [e-mail]
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2018 – 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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for
the different types of ISO documents should be noted (see www.iso.org/directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
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© IEEE 2018 – All rights reserved
iii
Abstract: Within the context of the ISO/IEEE 11073™ family of standards for point-of-care
medical device communication, a Participant Model derived from the ISO/IEEE11073-10201
Domain Information Model is provided in this standard. The Participant Model specifies the
structure of medical information objects. This standard also defines an abstract Communication
Model to support the exchange of medical information objects. All elements of the Participant
Model and Communication Model are specified using XML Schema. Core subjects of the
Participant Model comprise modelling of medical device-related data, e.g., measurements and
settings, alert systems, contextual information (e.g., patient demographics and location
information), remote control, and archival information. Model extensibility is provided inherently
through the use of XML Schema.
Keywords: alert systems, IEEE 11073-10207™, medical device communication, patient, point-
of-care, remote control, service-oriented architecture, XML Schema
•
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Participants
At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Point of Care
Devices Working Group had the following membership:
Jan Wittenber, Chair
Stefan Schlichting, Subgroup Chair
Bjoern Anderson Frank Golatowski Stephan Poehlsen
Malcolm Clarke David Gregorczyk Tracy Rausch
Todd Cooper Kai Hassing John Rhoads
Chris Courville John Hatcliff Paul Schluter
Michael Faughn Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Joerg-Uwe Meyer
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen David Gregorczyk Martin Kasparick
Susan Burgess Randall Groves Joerg-Uwe Meyer
Craig Carlson Kai Hassing Stephan Poehlsen
Keith Chow Robert Heile Beth Pumo
Malcolm Clarke Werner Hoelzl Stefan Schlichting
Todd Cooper Noriyuki Ikeuchi Eugene Stoudenmire
Sourav Dutta Atsushi Ito Walter Struppler
Kenneth Fuchs Stefan Karl J. Wiley
Joel Goergen Piotr Karocki Jan Wittenber
Frank Golatowski Oren Yuen
When the IEEE-SA Standards Board approved this standard on 6 December 2017, it had the following
membership:
Jean-Philippe Faure, Chair
Gary Hoffman, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Chuck Adams
Thomas Kochy Robby Robson
Masayuki Ariyoshi Joseph L. Koepfinger* Dorothy Stanley
Ted Burse Kevin Lu Adrian Stephens
Stephen Dukes Daleep Mohla Mehmet Ulema
Doug Edwards Damir Novosel Phil Wennblom
J. Travis Griffith Ronald C. Petersen Howard Wolfman
Michael Janezic Annette D. Reilly Yu Yuan
*Member Emeritus
Introduction
This introduction is not part of IEEE Std 11073-10207-2017, Health informatics—Point-of-care medical device
communication—Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical
Device Communication.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
systems. They provide automatic and detailed electronic data capture of patient vital signs information and
device operational data. The primary goals of these standards are to
 Provide real-time, plug-and-play interoperability for patient-connected medical devices.
 Facilitate the efficient exchange of vital signs and medical device data, acquired at the point of
care, in all health care environments.
“Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or
processed in fractions of a second. “Plug-and-play” means that all the clinician has to do is make the
connection—the systems automatically detect, configure, and communicate without any other human
interaction.
“Efficient exchange of medical device data” means that information that is captured at the point of care
(e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of
applications without extensive software and equipment support and without needless loss of information.
The standards are especially targeted at acute and continuing care devices, such as patient monitors,
ventilators, infusion pumps, and electrocardiogram (EKG) devices. This family of standards can be layered
together to provide connectivity optimized for the specific devices being interfaced.
Note that normative statements of requirements are presented in this standard in the following manner:
Rnnnn: Statement text here.
where "nnnn" is replaced by a number that is unique among the requirements in this standard and thereby
forms a unique requirement identifier, for example,
R0007: All HANDLEs SHALL be unique within one MDIB sequence of a SERVICE PROVIDER.

Contents
1. Overview .21
1.1 Scope .21
1.2 Purpose .21
2. Normative references .22
3. Definitions and notational conventions .23
3.1 Definitions .23
3.2 Notational conventions .25
4. Introduction to BICEPS .28
5. Participant Model .30
5.1 Overview .30
5.2 Background .30
5.3 Descriptive part.34
5.4 State part .41
6. Alert signal delegation .49
6.1 General .49
6.2 Delegable alert signals .49
6.3 Fallback alert signals .52
7. Communication Model .53
7.1 General .53
7.2 Message exchange patterns .53
7.3 Service Model .54
7.4 Message Model .59
8. Extension Model .62
9. Discovery Model .63
9.1 General .63
9.2 Implicit discovery .63
9.3 Explicit discovery .63
10. Nonfunctional requirements .64
10.1 General .64
10.2 Patient safety considerations .64
10.3 Cybersecurity considerations .64
10.4 Clinical effectiveness .65
10.5 Regulatory considerations .65
11. Conformance .66
11.1 Overview .66
11.2 General format .66
11.3 ICS tables .67
Annex A (normative) Extension Model .70
A.1 Extension .70
A.2 ExtensionType .71

A.3 MustUnderstand .71
Annex B (normative) Participant Model .72
B.1 AbstractAlertDescriptor .74
B.2 AbstractAlertState .74
B.3 AbstractAlertState/@ActivationState .75
B.4 AbstractComplexDeviceComponentDescriptor .75
B.5 AbstractComplexDeviceComponentDescriptor/AlertSystem .76
B.6 AbstractComplexDeviceComponentDescriptor/Sco .77
B.7 AbstractComplexDeviceComponentState .78
B.8 AbstractContextDescriptor .79
B.9 AbstractContextState .80
B.10 AbstractContextState/@ContextAssociation .81
B.11 AbstractContextState/@BindingMdibVersion .81
B.12 AbstractContextState/@UnbindingMdibVersion.81
B.13 AbstractContextState/@BindingStartTime .82
B.14 AbstractContextState/@BindingEndTime .82
B.15 AbstractContextState/Validator .82
B.16 AbstractContextState/Identification .83
B.17 AbstractDescriptor .83
B.18 AbstractDescriptor/@Handle .84
B.19 AbstractDescriptor/@DescriptorVersion .84
B.20 AbstractDescriptor/@SafetyClassification .84
B.21 AbstractDescriptor/Type .85
B.22 AbstractDeviceComponentDescriptor .86
B.23 AbstractDeviceComponentDescriptor/ProductionSpecification .86
B.24 AbstractDeviceComponentDescriptor/ProductionSpecification/SpecType .87
B.25 AbstractDeviceComponentDescriptor/ProductionSpecification/ ProductionSpec .88
B.26 AbstractDeviceComponentDescriptor/ProductionSpecification/ComponentId .88
B.27 AbstractDeviceComponentState .89
B.28 AbstractDeviceComponentState/@ActivationState .90
B.29 AbstractDeviceComponentState/@OperatingHours .90
B.30 AbstractDeviceComponentState/@OperatingCycles .90
B.31 AbstractDeviceComponentState/CalibrationInfo .90
B.32 AbstractDeviceComponentState/NextCalibration.91
B.33 AbstractDeviceComponentState/PhysicalConnector .92
B.34 AbstractMetricDescriptor .93
B.35 AbstractMetricDescriptor/@MetricCategory .94
B.36 AbstractMetricDescriptor/@DerivationMethod.94
B.37 AbstractMetricDescriptor/@MetricAvailability .95
B.38 AbstractMetricDescriptor/@MaxMeasurementTime .95
B.39 AbstractMetricDescriptor/@MaxDelayTime .95
B.40 AbstractMetricDescriptor/@DeterminationPeriod.96
B.41 AbstractMetricDescriptor/@LifeTimePeriod .96
B.42 AbstractMetricDescriptor/@ActivationDuration .96
B.43 AbstractMetricDescriptor/Unit .97
B.44 AbstractMetricDescriptor/BodySite .98
B.45 AbstractMetricDescriptor/Relation .99
B.46 AbstractMetricDescriptor/Relation/@Kind .100
B.47 AbstractMetricDescriptor/Relation/@Entries .100
B.48 AbstractMetricDescriptor/Relation/Code .101
B.49 AbstractMetricDescriptor/Relation/Identification .102
B.50 AbstractMetricState .103
B.51 AbstractMetricState/@ActivationState .104
B.52 AbstractMetricState/@ActiveDeterminationPeriod .104
B.53 AbstractMetricState/@LifeTimePeriod .104

B.54 AbstractMetricState/BodySite.105
B.55 AbstractMetricState/PhysicalConnector .106
B.56 AbstractMetricValue .106
B.57 AbstractMetricValue/@StartTime .107
B.58 AbstractMetricValue/@StopTime .107
B.59 AbstractMetricValue/@DeterminationTime .107
B.60 AbstractMetricValue/MetricQuality .107
B.61 AbstractMetricValue/MetricQuality/@Validity.108
B.62 AbstractMetricValue/MetricQuality/@Mode .108
B.63 AbstractMetricValue/MetricQuality/@Qi .108
B.64 AbstractMetricValue/Annotation .109
B.65 AbstractMetricValue/Annotation/Type .109
B.66 AbstractMultiState .110
B.67 AbstractMultiState/@Handle .111
B.68 AbstractMultiState/Category .111
B.69 AbstractOperationDescriptor .112
B.70 AbstractOperationDescriptor/@OperationTarget .113
B.71 AbstractOperationDescriptor/@MaxTimeToFinish.113
B.72 AbstractOperationDescriptor/@InvocationEffectiveTimeout .113
B.73 AbstractOperationDescriptor/@Retriggerable .113
B.74 AbstractOperationDescriptor/@AccessLevel .114
B.75 AbstractOperationState .114
B.76 AbstractOperationState/@OperatingMode .115
B.77 AbstractSetStateOperationDescriptor .115
B.78 AbstractSetStateOperationDescriptor/ModifiableData .116
B.79 AbstractState .116
B.80 AbstractState/@StateVersion .117
B.81 AbstractState/@DescriptorHandle .117
B.82 AbstractState/@DescriptorVersion .117
B.83 ActivateOperationDescriptor .118
B.84 ActivateOperationDescriptor/Argument .119
B.85 ActivateOperationDescriptor/Argument/ArgName .119
B.86 ActivateOperationDescriptor/Argument/Arg .120
B.87 ActivateOperationState .120
B.88 AlertConditionDescriptor .121
B.89 AlertConditionDescriptor/@Kind .122
B.90 AlertConditionDescriptor/@Priority .122
B.91 AlertConditionDescriptor/@DefaultConditionGenerationDelay .122
B.92 AlertConditionDescriptor/@CanEscalate .122
B.93 AlertConditionDescriptor/@CanDeescalate .123
B.94 AlertConditionDescriptor/Source .123
B.95 AlertConditionDescriptor/CauseInfo .123
B.96 AlertConditionState .124
B.97 AlertConditionState/@ActualConditionGenerationDelay .125
B.98 AlertConditionState/@ActualPriority .125
B.99 AlertConditionState/@Rank .125
B.100 AlertConditionState/@Presence .125
B.101 AlertConditionState/@DeterminationTime .125
B.102 AlertSignalDescriptor .126
B.103 AlertSignalDescriptor/@ConditionSignaled .127
B.104 AlertSignalDescriptor/@Manifestation.127
B.105 AlertSignalDescriptor/@Latching .128
B.106 AlertSignalDescriptor/@DefaultSignalGenerationDelay .128
B.107 AlertSignalDescriptor/@MinSignalGenerationDelay .128
B.108 AlertSignalDescriptor/@MaxSignalGenerationDelay .128
B.109 AlertSignalDescriptor/@SignalDelegationSupported .128

B.110 AlertSignalDescriptor/@AcknowledgementSupported .128
B.111 AlertSignalDescriptor/@AcknowledgeTimeout .129
B.112 AlertSignalState .129
B.113 AlertSignalState/@ActualSignalGenerationDelay .130
B.114 AlertSignalState/@Presence .130
B.115 AlertSignalState/@Location .130
B.116 AlertSignalState/@Slot .130
B.117 AlertSystemDescriptor .131
B.118 AlertSystemDescriptor/@MaxPhysiologicalParallelAlarms .132
B.119 AlertSystemDescriptor/@MaxTechnicalParallelAlarms .132
B.120 AlertSystemDescriptor/@SelfCheckPeriod .132
B.121 AlertSystemDescriptor/AlertCondition .132
B.122 AlertSystemDescriptor/AlertSignal .133
B.123 AlertSystemState .134
B.124 AlertSystemState/@LastSelfCheck .
...