EN ISO/IEEE 11073-10201:2020

SLOVENSKI STANDARD
01-september-2020
Nadomešča:
SIST EN ISO 11073-10201:2005
Zdravstvena informatika - Interoperabilnost naprav - 10201. del: Komunikacija
medicinskih naprav na mestu oskrbe - Informacijski model domene (ISO/IEEE
11073-10201:2020)
Health informatics- Device interoperability - Part 10201: Point-of-care medical device
communication - Domain information model (ISO/IEEE 11073-10201:2020)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
10201: Bereichs-Informationsmodell (ISO/IEEE 11073-10201:2020)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 10201: Modèle d'information du domaine (ISO/IEEE 11073-10201:2020)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10201:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO/IEEE 11073-
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2020
ICS 35.240.80 Supersedes EN ISO 11073-10201:2005
English Version
Health informatics - Device interoperability - Part 10201:
Point-of-care medical device communication - Domain
information model (ISO/IEEE 11073-10201:2020)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Kommunikation
- Partie 10201: Communication entre dispositifs patientennaher medizinischer Geräte - Teil 10201:
médicaux sur le site des soins - Modèle d'informations Bereichs-Informationsmodell (ISO/IEEE 11073-
du domaine (ISO/IEEE 11073-10201:2020) 10201:2020)
This European Standard was approved by CEN on 2 May 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10201:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO/IEEE 11073-10201:2020) has been prepared by Technical Committee ISO/TC
215 "Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics”
the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2020, and conflicting national standards
shall be withdrawn at the latest by December 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11073-10201:2005.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10201:2020 has been approved by CEN as EN ISO/IEEE 11073-
10201:2020 without any modification.

INTERNATIONAL ISO/IEEE
STANDARD 11073-
Second edition
2020-04
Health informatics — Device
interoperability —
Part 10201:
Point-of-care medical device
communication — Domain
information model
Informatique de santé — Interopérabilité des dispositifs —
Partie 10201: Communication entre dispositifs médicaux sur le site
des soins — Modèle d'informations du domaine
Reference number
ISO/IEEE 11073-10201:2020(E)
©
IEEE 2019
ISO/IEEE 11073-10201:2020(E)
© IEEE 2019
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: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2019 – All rights reserved

ISO/IEEE 11073-10201:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non‐governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
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
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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT),
see www.iso.org/iso/foreword.html.
ISO/IEEE 11073‐10201 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073‐10201‐2018) 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.
This second edition cancels and replaces the first edition (ISO/IEEE 11073‐10201:2004), which has been
technically revised.
A list of all parts in the ISO/IEEE 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 2019 – All rights reserved iii

IEEE Std 11073-10201™-2018
(Revision of
IEEE Std 11073-10201-2004)
Health informatics—Point-of-care medical device communication

Part 10201: Domain Information Model
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 5 December 2018
IEEE-SA Standards Board
ISO/IEEE 11073-10201:2020(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care medical
device communication, an abstract, object-oriented domain information model that specifies the
structure of exchanged information, as well as the events and services that are supported by
each type of object, is provided in this standard. All data structure elements are specified using
abstract syntax (ASN.1) and may be applied to many different implementation technologies,
transfer syntaxes, and application service models. Core subjects include medical, alert, system,
patient, control, archival, communication, and extended services. Model extensibility is supported,
and a conformance model and statement template is provided.
Keywords: abstract syntax, alarm, alert, ASN.1, DIM, domain information model, IEEE 11073-
10201™, information model, medical device communications, medical information bus, MIB,
object-oriented, patient, POC, point-of-care, remote control
•
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
All rights reserved. Published 10 June 2019. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics Engineers,
Incorporated.
OMG and UML are registered trademarks of Object Management Group, Inc. in the United States and/or other countries.
PDF: ISBN 978-1-5044-5433-9 STD23484
Print: ISBN 978-1-5044-5434-6 STDPD23484
IEEE prohibits discrimination, harassment, and bullying.
For more information, visit http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
ISO/IEEE 11073-10201:2020(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE documents are made available for use subject to important notices and legal disclaimers. These
notices and disclaimers, or a reference to this page, appear in all standards and may be found under the
heading “Important Notices and Disclaimers Concerning IEEE Standards Documents.” They can also be
obtained on request from IEEE or viewed at http://standards.ieee.org/ipr/disclaimers.html.
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are
developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards
Association (“IEEE-SA”) Standards Board. IEEE (“the Institute”) develops its standards through a
consensus development process, approved by the American National Standards Institute (“ANSI”), which
brings together volunteers representing varied viewpoints and interests to achieve the final product. IEEE
Standards are documents developed through scientific, academic, and industry-based technical working
groups. Volunteers in IEEE working groups are not necessarily members of the Institute and participate
without compensation from IEEE. While IEEE administers the process and establishes rules to promote
fairness in the consensus development process, IEEE does not independently evaluate, test, or verify the
accuracy of any of the information or the soundness of any judgments contained in its standards.
IEEE Standards do not guarantee or ensure safety, security, health, or environmental protection, or ensure
against interference with or from other devices or networks. Implementers and users of IEEE Standards
documents are responsible for determining and complying with all appropriate safety, security,
environmental, health, and interference protection practices and all applicable laws and regulations.
IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and
expressly disclaims all warranties (express, implied and statutory) not included in this or any other
document relating to the standard, including, but not limited to, the warranties of: merchantability; fitness
for a particular purpose; non-infringement; and quality, accuracy, effectiveness, currency, or completeness
of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort.
IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there
are no other ways to produce, test, measure, purchase, market, or provide other goods and services related
to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved
and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other
services for, or on behalf of, any person or entity nor is IEEE undertaking to perform any duty owed by any
other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his
or her own independent judgment in the exercise of reasonable care in any given circumstances or, as
appropriate, seek the advice of a competent professional in determining the appropriateness of a given
IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO:
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
ISO/IEEE 11073-10201:2020(E)
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
that an IEEE standard is translated, only the English version published by IEEE should be considered the
approved IEEE standard.
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE-SA Standards Board
Operations Manual shall not be considered or inferred to be the official position of IEEE or any of its
committees and shall not be considered to be, or be relied upon as, a formal position of IEEE. At lectures,
symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall
make it clear that his or her views should be considered the personal views of that individual rather than the
formal position of IEEE.
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of
membership affiliation with IEEE. However, IEEE does not provide consulting information or advice
pertaining to IEEE Standards documents. Suggestions for changes in documents should be in the form of a
proposed change of text, together with appropriate supporting comments. Since IEEE standards represent a
consensus of concerned interests, it is important that any responses to comments and questions also receive
the concurrence of a balance of interests. For this reason, IEEE and the members of its societies and
Standards Coordinating Committees are not able to provide an instant response to comments or questions
except in those cases where the matter has previously been addressed. For the same reason, IEEE does not
respond to interpretation requests. Any person who would like to participate in revisions to an IEEE
standard is welcome to join the relevant IEEE working group.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory
requirements. Implementers of the standard are responsible for observing or referring to the applicable
regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not
in compliance with applicable laws, and these documents may not be construed as doing so.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws.
They are made available by IEEE and are adopted for a wide variety of both public and private uses. These
include both use, by reference, in laws and regulations, and use in private self-regulation, standardization,
and the promotion of engineering practices and methods. By making these documents available for use and
adoption by public authorities and private users, IEEE does not waive any rights in copyright to the
documents.
ISO/IEEE 11073-10201:2020(E)
Photocopies
Subject to payment of the appropriate fee, IEEE will grant users a limited, non-exclusive license to
photocopy portions of any individual standard for company or organizational internal use or individual,
non-commercial use only. To arrange for payment of licensing fees, please contact Copyright Clearance
Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA; +1 978 750 8400. Permission
to photocopy portions of any individual standard for educational classroom use can also be obtained
through the Copyright Clearance Center.
Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
corrigenda, or errata. A current IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect.
Every IEEE standard is subjected to review at least every ten years. When a document is more than ten
years old and has not undergone a revision process, it is reasonable to conclude that its contents, although
still of some value, do not wholly reflect the present state of the art. Users are cautioned to check to
determine that they have the latest edition of any IEEE standard.
In order to determine whether a given document is the current edition and whether it has been amended
through the issuance of amendments, corrigenda, or errata, visit IEEE Xplore at http://ieeexplore.ieee.org/
or contact IEEE at the address listed previously. For more information about the IEEE-SA or IEEE’s
standards development process, visit the IEEE-SA Website at http://standards.ieee.org.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE-SA Website at http://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, 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 the IEEE Standards Association.
ISO/IEEE 11073-10201:2020(E)
Participants
At the time this IEEE standard was completed, the Point-of-Care Devices Working Group had the
following membership:
John Rhoads, Chair
Michael Faughn, Subgroup Chair
Bjoern Anderson David Gregorczyk Tracy Rausch
Malcolm Clarke Kai Hassing Stefan Schlichting
Todd Cooper John Hatcliff Paul Schluter
Chris Courville Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Frank Golatowski Joerg-Uwe Meyer Jan Wittenber
Stephan Poehlsen
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen Kai Hassing Stefan Schlichting
Michael Bayer Werner Hoelzl Paul Schluter
Keith Chow Noriyuki Ikeuchi Walter Struppler
Malcolm Clarke Atsushi Ito Ganesh Subramanian
Michael Faughn Stefan Karl Thomas Tullia
David Fuschi Piotr Karocki Jan Wittenber
David Gregorczyk Martin Kasparick Oren Yuen
Randall Groves H. Moll Daidi Zhong
John Rhoads
When the IEEE-SA Standards Board approved this standard on 5 December 2018, it had the following
membership:
Jean-Philippe Faure, Chair
Gary Hoffman, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Ted Burse Xiaohui Liu Robby Robson
Guido R. Hiertz Kevin Lu Dorothy Stanley
Christel Hunter Daleep Mohla Mehmet Ulema
Joseph L. Koepfinger* Andrew Myles Phil Wennblom
Thomas Koshy Paul Nikolich Philip Winston
Hung Ling Ronald C. Petersen Howard Wolfman
Dong Liu Annette D. Reilly Jingyi Zhou
*Member Emeritus
ISO/IEEE 11073-10201:2020(E)
Introduction
This introduction is not part of IEEE Std 11073-10201-2018, Health informatics—Point-of-care medical device
communication—Part 10201: Domain Information Model.
ISO/IEEE 11073 standards enable communication between different medical devices and between medical
devices and other IT systems for information and for command and control. The primary goals are to:
 Provide real-time plug-and-play interoperability for patient-connected medical devices
 Facilitate the efficient exchange of patient related data and medical device related data, acquired at
the point-of-care (POC), 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 when a device or system is connected to another device or system, detection,
configuration, and the initiation of communication all occur automatically andwithout any other human
interaction.
“Efficient exchange of medical device data” means that information that is captured at the POC (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. This standard
is especially targeted at acute and continuing care devices, such as patient monitors, ventilators, infusion
pumps, ECG devices, etc. It is a member of a family of standards that can be layered together to provide
connectivity optimized for the specific devices being interfaced.

ISO/IEEE 11073-10201:2020(E)
Contents
1. Scope . 9
2. Normative references . 9
3. Definitions, acronyms, and abbreviations . 10
3.1 Definitions . 10
3.2 Abbreviations and acronyms . 13
4. General requirements . 14
5. Domain information model (DIM) . 15
5.1 General . 15
5.2 Package diagram–Overview . 18
5.3 Model for the Medical Package . 19
5.4 Model for the Alert Package . 23
5.5 Model for the System Package . 25
5.6 Model for the Control Package . 27
5.7 Model for the ExtendedServices Package . 30
5.8 Model for the Communication Package . 33
5.9 Model for the Archival Package . 35
5.10 Model for the Patient Package . 37
5.11 DIM—Dynamic model . 37
6. DIM class definitions . 42
6.1 Overview . 42
6.2 Top class . 51
6.3 Medical package . 52
6.4 Alert package . 89
6.5 System package . 95
6.6 Control package .115
6.7 ExtendedServices package .129
6.8 Communication package .142
6.9 Archival package .149
6.10 Patient package .156
7. Service model for communicating systems .159
7.1 General .159
7.2 Communicating systems .159
7.3 General service model overview .160
7.4 General object management services definition .162
8. MDIB nomenclature .167
9. Conformance model .168
9.1 Applicability .168
9.2 Conformance specification .168
9.3 ICSs .169
Annex A (informative) Bibliography .175

ISO/IEEE 11073-10201:2020(E)
Health informatics—Point-of-care medical device communication

Part 10201: Domain Information Model
1. Scope
The scope of this project is to define a general object-oriented information model that may be used to
structure information and identify services used in point-of-care (POC) medical device communications.
The scope is primarily focused on acute care medical devices and the communication of patient vital signs
information.
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so each referenced document is cited in text and its relationship to this document is
explained). For dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments or corrigenda) applies.
ISO/IEC 8824-1, Information technology — Abstract Syntax Notation One (ASN.1) — Part 1: Specification
of basic notation.
ISO/IEEE 11073-10101, Health informatics — Point-of-care medical device communication — Part 10101:
Nomenclature.
ISO/IEEE 11073-20101, Health informatics — Point-of-care medical device communication — Part 20101:
Application profiles – Base standard.
® ® ® 3
OMG Unified Modeling Language (OMG UML ) 2.5.1.

ISO/IEC documents are available from the International Organization for Standardization (http://www.iso.org/), the International
Electrotechnical Commission (http://www.iec.ch), and the American National Standards Institute (http://www.ansi.org/).
ISO/IEEE documents are available from the International Organization for Standardization (http://www.iso.org/) and the Institute of
Electrical and Electronics Engineers (http://standards.ieee.org/).
The OMG UML standard can be freely downloaded at https://www.omg.org/spec/UML/
ISO/IEEE 11073-10201:2020(E)
IEEE Std 11073-10201-2018
IEEE Standard for Part 10201: Domain Information Model
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this document, the following terms and definitions apply. The IEEE Standards
Dictionary Online should be referenced for terms not defined in this clause.
agent: Device that provides data in a manager-agent communicating system.
alarm: Signal that indicates abnormal events occurring to the patient or the device system.
alert: Synonym for the combination of patient-related physiological alarms, technical alarms, and
equipment-user advisory signals.
alert condition: The active (true) state of a physiologic alarm (primarily related to the patient), technical
alarm (primarily related to a device), or an advisory that is typically reported to clinicians, physicians, or
other healthcare staff, for responding to patient needs or related workflows.
alert monitor: Object representing the output of an alert system that considers multiple alert conditions in
a scope defined by objects that are contained by a single medical device system object. An alert monitor is
able to report individual, concurrent alert conditions as well as the overall system alert condition.
alert status: Object representing the output of an alert system that considers multiple alert conditions in a
scope defined by objects that are contained by either a single virtual medical device object or a single
medical device system object. An alert status is able to report concurrent alert conditions.
archival: Relating to the storage of data over a prolonged period.
association control service element (ACSE): Method used to establish logical connections between
medical device systems.
attribute: The definition of a property of an object.
channel: An object that groups together physiological measurement data and any derived data that have a
contextual relationship with each other.
class: A model which describes the properties and behaviors of a type of entity found within a problem
domain.
class diagram: Diagram showing connections between classes in a system.
communication controller: Part of a medical device system responsible for communications.
communication party: Actor of the problem domain that participates in the communication in that domain.
communication role: Role of a party in a communication situation defining the party’s behavior in the
communication. Associated with a communication role is a set of services that the party provides to other
parties.
data agent: As a medical device, a patient data acquisition system that provides the acquired data for other
devices.
The IEEE Standards Dictionary Online is available at http://dictionary.ieee.org/. An IEEE Account is required for access to the
dictionary, and one can be created at no charge on the dictionary sign-in page.
ISO/IEEE 11073-10201:2020(E)
IEEE Std 11073-10201-2018
IEEE Standard for Part 10201: Domain Information Model
data format: Arrangement of data in a file or stream.
data logger: A device that is functioning in its capacity as a data storage and archival system.
NOTE—There may be several different types of data loggers; clinical, technical, forensic, alarm condition, user logs.
data structure: A data organization format that is implemented by an application.
dictionary: Description of the contents of the medical data information base (MDIB) containing vital signs
information, device information, demographics, and other elements of the MDIB.
discrete parameter: Measured, calculated, or manually entered value that can be expressed as a single
numeric or textual value.
Example: A non-invasive systolic blood pressure (measured), cardiac index (calculated), gender male
or female.
domain information model (DIM): The model describing common concepts and relationships for a
problem domain.
event: A change in device status that is communicated by a notification reporting service.
event report: Service (provided by the common medical device information service element ) to report an
event relating to a managed object instance.
framework: A structure of processes and specifications designed to support the accomplishment of a
specific task.
graphic parameter: Parameter that requires multiple regularly sampled data points in order to be
expressed properly.
Example: A single ECG waveform snippet.
host system: Term used as an abstraction of a medical system to which measurement devices are attached.
information service element: Instances in the medical data information base.
instance: The realization of an abstract concept or specification, e.g., class instance, application instance,
information service element instance, virtual medical device instance, operating instance.
instance method: A procedure or process that defines a behavior exhibited by the instances of a class (i.e.,
objects). Instance methods provide the interface by which the properties of an object may be accessed or
modified.
intensive care unit (ICU): The unit within a medical facility in which patients are managed using multiple
modes of monitoring and therapy.
interchange format: The representation of the data elements and the structure of the message containing
those data elements while in transfer between systems. The interchange format consists of a data set of
construction elements and a syntax. The representation is technology specific.
interoperability: The ability of two or more devices or systems to exchange information in a format that is
usable by the receivers of the information.

Notes in text, tables, and figures of a standard are given for information only and do not contain requirements needed to implement
this standard.
ISO/IEEE 11073-10201:2020(E)
IEEE Std 11073-10201-2018
IEEE Standard for Part 10201: Domain Information Model
latency: In a communications scenario, the time delay between sending a signal from one device and
receiving it by another device.
lower layers: Layer 1 to Layer 4 of the International Organization for Standardization (ISO)/open systems
interconnection (OSI) reference model. These layers cover mechanical, electrical, and general
communication protocol specifications.
manager: Device that receives data in a manager-agent communicating system.
manager-agent model: Communication model where one device (i.e., agent) provides data and another
device (i.e., manager) receives data.
medical data information base (MDIB): The concept of an object-oriented database storing (at least) vital
signs information.
medical device: A device, apparatus, or system used for patient monitoring, treatment, or therapy, which
does not normally enter metabolic pathways. For the purposes of this standard, the scope of medical
devices is further limited to patient-connected medical devices that provide support for electronic
communications.
medical device system (MDS): Abstraction for system comprising one or more medical functions. In the
context of this standard, the term is specifically used as an object-oriented abstraction of a device that
provides medical information in the form of instances of the classes that are defined in this standard.
monitor: A medical device designed to acquire, display, record, and/or analyze patient data and to alert
caregivers of events needing their attention.
object: A particular instance of a class. An object represents a physical or logical occurrence of an actual
medical device or medical device component. Syn: object instance.
object instance: See: object.
object-oriented analysis: Method of analysis where the problem domain is modelled in the form of classes
and the relationships between those classes.
open system: A set of protocols allowing computers of different origins to be linked together.
operation: A function or transformation that may be applied to or by objects (sometimes also called service).
problem domain: The field of health care under consideration in a modeling process.
protocol: A standard set of rules describing the transfer of data between devices. It specifies the format of
the data and specifies the signals to start, control, and end the transfer.
real time: At the time when an event or process occurs.
scanner: An observer and “summarizer” of attribute values.
scenario: A formal description of a class of business activities including the semantics of business
agreements, conventions, and information content.
service: A specific behavior that a communication party in a specific role is responsible for exhibiting.
syntax (i.e., of an interchange format): The rules for combining the construction elements of the
...