Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature

ISO 11073-10101:2004 covers nomenclature architecture for point-of-care (POC) medical device communication (MDC). It defines the overall architecture of the organization and relationships among nomenclature components and provides specifications of semantics and syntaxes. ISO 11073-10101:2004 is intended for use within the context of IEEE Std 1073,1 which sets out the relationship between this and other documents in the POC MDC series.

Informatique de santé — Communication entre dispositifs médicaux sur le site des soins — Partie 10101: Nomenclature

General Information

Status
Withdrawn
Publication Date
14-Dec-2004
Withdrawal Date
14-Dec-2004
Current Stage
9599 - Withdrawal of International Standard
Start Date
28-Aug-2020
Completion Date
30-Oct-2025

Relations

Effective Date
23-Apr-2020
Effective Date
23-Apr-2020
Standard

ISO/IEEE 11073-10101:2004 - Health informatics -- Point-of-care medical device communication

English language
490 pages
sale 15% off
Preview
sale 15% off
Preview
Standard

ISO/IEEE 11073-10101:2004 - Health informatics -- Point-of-care medical device communication

English language
490 pages
sale 15% off
Preview
sale 15% off
Preview

Frequently Asked Questions

ISO/IEEE 11073-10101:2004 is a standard published by the International Organization for Standardization (ISO). Its full title is "Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature". This standard covers: ISO 11073-10101:2004 covers nomenclature architecture for point-of-care (POC) medical device communication (MDC). It defines the overall architecture of the organization and relationships among nomenclature components and provides specifications of semantics and syntaxes. ISO 11073-10101:2004 is intended for use within the context of IEEE Std 1073,1 which sets out the relationship between this and other documents in the POC MDC series.

ISO 11073-10101:2004 covers nomenclature architecture for point-of-care (POC) medical device communication (MDC). It defines the overall architecture of the organization and relationships among nomenclature components and provides specifications of semantics and syntaxes. ISO 11073-10101:2004 is intended for use within the context of IEEE Std 1073,1 which sets out the relationship between this and other documents in the POC MDC series.

ISO/IEEE 11073-10101:2004 is classified under the following ICS (International Classification for Standards) categories: 01.040.35 - Information technology (Vocabularies); 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO/IEEE 11073-10101:2004 has the following relationships with other standards: It is inter standard links to ISO/IEEE 11073-10101:2004/Amd 1:2017, ISO/IEEE 11073-10101:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ISO/IEEE 11073-10101:2004 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


INTERNATIONAL
ISO/IEEE
STANDARD
11073-10101
First edition
2004-12-15
Health informatics — Point-of-care
medical device communication —
Part 10101:
Nomenclature
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 10101: Nomenclature
Reference number
© ISO/IEEE 2004
Health informatics — Point-of-care
medical device communication —
Part 10101:
Nomenclature
Sponsor

IEEE 1073 Standard Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 24 June 2004
IEEE-SA Standards Board
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe’s licensing policy, this file may be printed
or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the com-
puter performing the editing. In downloading this file, parties accept therein the responsibility of not infringing
Adobe’s licensing policy. Neither the ISO Central Secretariat nor the IEEE accepts any liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the
PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for
use by ISO member bodies and IEEE members. In the unlikely event that a problem relating to it is found, please
inform the ISO Central Secretariat or the IEEE at the address given below.
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical
device communication (MCD), this standard provides the nomenclature that supports both the domain infor-
mation model and service model components of the standards family, as well as the semantic content
exchanged with medical devices. The nomenclature is specialized for patient vital signs information represen-
tation and medical device informatics, with major areas including concepts for electrocardiograph (ECG),
haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as specialized
units of measurement, general device events, alarms, and body sites. The standard defines both the architec-
ture and major components of the nomenclature, along with extensive definitions for each conceptual area.

Keywords: codes, information model, medical device communication, nomenclature, ontology, patient,
point-of-care, POC, semantics, service model, terminology
This ISO/IEEE document is an International Standard and is copyright-protected by ISO and the IEEE. Except as
permitted under the applicable laws of the user’s country, neither this ISO/IEEE standard nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording
or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO or the IEEE at the addresses below.
ISO copyright office Institute of Electrical and Electronics Engineers
Case postale 56 · CH-1211 Geneva 20 Standards Association
Tel. + 41 22 749 01 11 Manager, Standards Intellectual Property
Fax + 41 22 749 09 47 445 Hoes Lane
E-mail copyright@iso.org Piscataway, NJ 08854
Web www.iso.org E-mail: stds.ipr@ieee.org
Web: www.ieee.org
Published 15 December 2004. 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.
HL7 is a registered trademark of Health Level Seven, Inc. (www.hl7.org).
SNOMED is a registered trademark of the College of American Pathologists; Norfield, IL; (800) 323-4040 (http://
www.cap.org).
Print: ISBN 0-7381-4087-2 SH95255
PDF: ISBN 0-7381-4088-0 SS95255
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.
ii Copyright © 2004 ISO/IEEE. All rights reserved.

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 develop-
ment 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 with-
out compensation. While the IEEE administers the process and establishes rules to promote fairness in the consensus devel-
opment process, the IEEE does not independently evaluate, test, or verify the accuracy of any of the information contained
in its standards.
Use of an IEEE Standard is wholly voluntary. The IEEE disclaims liability for any personal injury, property or other dam-
age, of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting
from the publication, use of, or reliance upon this, or any other IEEE Standard document.
The IEEE does not warrant or represent the accuracy or content of the material contained herein, and expressly disclaims
any express or implied warranty, including any implied warranty of merchantability or fitness for a specific purpose, or that
the use of the material contained herein is free from patent infringement. IEEE Standards documents are supplied “AS IS.”
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. Every IEEE Standard is subjected to review at least every five years for revi-
sion or reaffirmation. When a document is more than five years old and has not been reaffirmed, 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 publishing and making this document available, the IEEE is not suggesting or rendering professional or other services
for, or on behalf of, any person or entity. Nor is the IEEE undertaking to perform any duty owed by any other person or
entity to another. Any person utilizing this, and any other IEEE Standards document, should rely upon the advice of a com-
petent professional in determining the exercise of reasonable care in any given circumstances.
Interpretations: Occasionally questions may arise regarding the meaning of portions of standards as they relate to specific
applications. When the need for interpretations is brought to the attention of IEEE, the Institute will initiate action to prepare
appropriate responses. Since IEEE Standards represent a consensus of concerned interests, it is important to ensure that any
interpretation has also received the concurrence of a balance of interests. For this reason, IEEE and the members of its soci-
eties and Standards Coordinating Committees are not able to provide an instant response to interpretation requests except in
those cases where the matter has previously received formal consideration. 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, explanation, or interpretation of the IEEE.
Comments for revision of IEEE Standards are welcome from any interested party, regardless of membership affiliation with
IEEE. Suggestions for changes in documents should be in the form of a proposed change of text, together with appropriate
supporting comments. Comments on standards and requests for interpretations should be addressed to:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
NOTE — 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 with respect to the exist-
ence or validity of any patent rights in connection therewith. The IEEE shall not be responsible for identifying
patents for which a license may be required by an IEEE standard or for conducting inquiries into the legal valid-
ity or scope of those patents that are brought to its attention.
Authorization to photocopy portions of any individual standard for internal or personal use is granted by the Institute of
Electrical and Electronics Engineers, Inc., provided that the appropriate fee is paid to Copyright Clearance Center. To
arrange for payment of licensing fee, 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.
iv Copyright © 2004 ISO/IEEE. All rights reserved.

ISO 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.
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.
A pilot project between ISO and the IEEE has been formed to develop and maintain a group of ISO/IEEE
standards in the field of medical devices as approved by Council resolution 43/2000. Under this pilot
project, IEEE is responsible for the development and maintenance of these standards with participation and
input from ISO member bodies.
Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. Neither ISO nor the IEEE shall be held responsible for identifying any or all such
patent rights.
Medicine and Biology Society.
IEEE Introduction
This introduction is not part of ISO/IEEE 11073-10101:2004(E), Health informatics — Point-of-care medical device
communication — Part 10101: Nomenclature.
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 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, ECG devices, etc. They comprise a family of standards that can be layered
together to provide connectivity optimized for the specific devices being interfaced.
Notice to users
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 with respect to the existence or
validity of any patent rights in connection therewith. The IEEE shall not be responsible for identifying
patents or patent applications for which a license may be required by to implement an IEEE standard or for
conducting inquiries into the legal validity or scope of those patents that are brought to its attention.
Errata
Errata, if any, for this and all other standards can be accessed at the following URL: http://
standards.ieee.org/reading/ieee/updates/errata/index.html. Users are encouraged to check this URL for
errata periodically.
Interpretations
Current interpretations can be accessed at the following URL: http://standards.ieee.org/reading/ieee/interp/
index.html.
vi Copyright © 2004 ISO/IEEE. All rights reserved.

Participants
At the time this standard was completed, the working group of the IEEE 1073 Standard Committee had the
following membership:
Todd H. Cooper, Chair
Michael Krämer
Wolfgang Bleicher Paul Rubel
Francis Cantraine
Alberto Macerata Lief Rystrøm
Mats Cardell Simon Meij Paul Schluter
Thomas Norgall
Michael Flötotto Michael Spicer
Ken Fuchs Thomas Penzel Lars Steubesand
Kai Hassing Francesco Pinciroli Alpo Värri
Melvin Reynolds
Gunther Hellmann Jan Wittenber
Jörg Kampmann Angelo Rossi Mori Paul Woolman
Ron Kirkham Christoph Zywietz
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Thomas Canup John Grider Melvin Reynolds
Michael Chilbert Kai Hassing Michael Spicer
Keith Chow Tom Kannally Richard Schrenker
Todd H. Cooper Robert Kennelly M. Michael Shabot
Grace Esche Randall Krohn Lars Steubesand
Kenneth Fuchs Yeou-Song Lee Gin-shu Young
Daniel Nowicki
When the IEEE-SA Standards Board approved this standard on 24 June 2004, it had the following
membership:
Don Wright, Chair
Steve M. Mills, Vice Chair
Judith Gorman, Secretary
Chuck Adams Mark S. Halpin Paul Nikolich
Stephen Berger Raymond Hapeman T. W. Olsen
Richard J. Holleman Ronald C. Petersen
Mark D. Bowman
Gary S. Robinson
Joseph A. Bruder Richard H. Hulett
Frank Stone
Bob Davis Lowell G. Johnson
Malcolm V. Thaden
Joseph L. Koepfinger*
Roberto de Marca Boisson
Doug Topping
Hermann Koch
Julian Forster*
Joe D. Watson
Thomas J. McGean
Arnold M. Greenspan
Daleep C. Mohla
*Member Emeritus
Also included are the following nonvoting IEEE-SA Standards Board liaisons:
Satish K. Aggarwal, NRC Representative
Richard DeBlasio, DOE Representative
Alan Cookson, NIST Representative
Don Messina
IEEE Standards Project Editor
Contents
1. Scope. 1
2. Conformance. 1
3. Normative references. 1
4. Terms and definitions . 2
5. Symbols (and abbreviated terms) . 2
6. Application. 4
7. Semantics . 4
7.1 Attribution. 5
7.2 Coding. 5
7.2.1 Context-sensitivity. 6
7.2.2 Grouping . 7
8. Syntax . 7
8.1 Transfer. 7
8.1.1 Types. 7
8.1.2 Notation . 8
8.2 Programmatic. 8
8.2.1 Attribution. 8
8.2.2 Notation . 9
9. Extensibility . 10
10. Version exporting . 10
Annex A (normative) Nomenclature semantics. 11
A.1 Overview of nomenclature for vital signs—semantics. 11
A.1.1 Introduction. 11
A.2 Code assignment to the MDIB elements . 12
A.2.1 Overview. 12
A.2.2 Basic rules.12
A.2.3 Coding spaces . 13
A.3 Data dictionary and codes for object-oriented modeling elements (Block A) . 18
A.3.1 Introduction. 18
A.3.2 Object-oriented modeling elements: inventory tables . 19
A.4 Data dictionary and codes for communication infrastructure (Block G). 42
A.4.1 Communication infrastructure: inventory tables . 42
A.5 Nomenclature, data dictionary, and codes for vital signs devices (Block A). 47
A.5.1 Introduction. 47
A.5.2 Base concepts. 48
A.5.3 First set of differentiating criteria . 48
A.5.4 Second set of differentiating criteria. 49
A.5.5 Third set of differentiating criteria. 49
viii Copyright © 2004 ISO/IEEE. All rights reserved.

A.5.6 Attributes .50
A.5.7 Code table . 50
A.6 Terminology and codes for units of measurement (Block B). 59
A.6.1 Introduction. 59
A.6.2 Orders of magnitude discriminator. 59
A.6.3 Units outside of SI . 60
A.6.4 Units of measurement . 60
A.7 Nomenclature, data dictionary, and codes for metrics (measurements and
enumerations) (Block C). 76
A.7.1 Nomenclature for ECG measurements . 76
A.7.2 Nomenclature for ECG enumerations. 93
A.7.3 Nomenclature, data dictionary, and codes for haemodynamic
monitoring measurements. 102
A.7.4 Nomenclature, data dictionary, and codes for respiratory measurements . 118
A.7.5 Nomenclature, data dictionary, and codes for common blood-gas, blood,
urine, and other fluid chemistry measurements. 150
A.7.6 Nomenclature, data dictionary, and codes for fluid output measurements. 157
A.7.7 Nomenclature, data dictionary, and codes for pumps. 161
A.7.8 Nomenclature, data dictionary, and codes for neurological monitoring
measurements. 177
A.7.9 Nomenclature, data dictionary, and codes for neurophysiologic enumerations . 190
A.7.10 Nomenclature, data dictionary, and codes for stimulation modes. 217
A.7.11 Nomenclature, data dictionary, and codes for miscellaneous measurements. 224
A.8 Nomenclature, data dictionary, and codes for body sites (Block D) . 228
A.8.1 Introduction. 228
A.8.2 Sites for neurophysiological signal monitoring: locations near peripheral nerves 228
A.8.3 Sites for neurophysiological signal monitoring: locations near muscles. 244
A.8.4 Sites for EEG-electrode placement on the head . 287
A.8.5 Sites for EOG signal monitoring . 294
A.8.6 Sites for general neurological monitoring measurements and drainage. 299
A.8.7 Sites for cardiovascular measurements. 301
A.8.8 Miscellaneous sites used in vital signs monitoring and measurement. 307
A.8.9 Qualifiers of body site locations . 322
A.9 Nomenclature, data dictionary, and codes for alerts (Block E) . 326
A.9.1 Introduction. 326
A.9.2 Diagnostic pattern events. 326
A.9.3 Device-related and environment-related events . 334
A.10 Nomenclature, data dictionary, and codes for external nomenclatures and messaging
standards (Block F). 357
A.10.1 Introduction. 357
A.10.2 Base concepts. 357
A.10.3 First set of differentiating criteria . 357
A.10.4 Second set of differentiating criteria. 358
A.10.5 Third set of differentiating criteria. 358
A.10.6 Code table . 358
Annex B (normative) Nomenclature syntax . 363
B.1 General . 363
B.1.1 Notation . 363
B.1.2 Partition codes. 363
B.1.3 Discriminator ranges. 364
B.2 Object infrastructure . 364
B.3 Medical supervisory control and data acquisition (SCADA) . 396
B.4 Events . 442
B.5 Dimensions . 458
B.6 Virtual attributes . 467
B.7 Parameter groups . 467
B.8 Body Sites . 467
B.9 Communication infrastructure . 483
B.10 External nomenclature . 486
Annex C (informative) Bibliography. 489
x Copyright © 2004 ISO/IEEE. All rights reserved.

Health informatics — Point-of-care
medical device communication —
Part 10101:
Nomenclature
1. Scope
The scope of this standard is nomenclature architecture for point-of-care (POC) medical device communica-
tion (MDC). It consists of three parts: the body of the standard, which defines the overall architecture of the
organization and relationships among nomenclature components; normative Annex A and Annex B, which
provide specifications of semantics and syntaxes, respectively; and informative Annex C, the bibliography.
This standard is intended for use within the context of IEEE Std 1073, which sets out the relationship
between this and other documents in the POC MDC series.
2. Conformance
There are no particular implementation conformance requirements defined in this standard, but some
requirements for nomenclature representation are established in this standard to guide specification of
semantics and syntax in other parts of the overall standard.
3. Normative references
The following normative documents contain provisions that, through reference in this text, constitute provi-
sions of ISO/IEEE 11073-10101. For dated references, subsequent amendments to, or revisions of, any of
these publications do not apply. However, parties to agreements based on ISO/IEEE 11073-10101 are
encouraged to investigate the possibility of applying the most recent editions of the normative documents
indicated below. For undated references, the latest edition of the normative document referred to applies.
Members of ISO and IEC maintain registers of currently valid international standards.
Information on references can be found in Clause 3.
CEN ENV 12611, Medical Informatics — Categorical structure of systems of concepts — Medical
Devices.
IEEE Std 1073™, IEEE Standard for Medical Device Communications—Overview and Framework.
ISO/IEC 8824 (all parts), Information technology — Abstract Syntax Notation One (ASN.1).
ISO/IEC 8825 (all parts), Information technology —ASN.1 encoding rules.
ISO/IEC 9596-1, Information technology — Open systems interconnection — Common Management Infor-
mation Protocol — Part 1: Specification.
ISO/IEEE 11073-10201, Health informatics — Point-of-care medical device communication — Part 10201:
Domain information model (referred to hereinafter as the “DIM”).
ISO/IEEE 11073-20101, Health informatics — Point-of-care medical device communication — Part 20101:
Application profiles – Base standard.
4. Terms and definitions
For the purposes of this standard, the following terms and definitions apply. The Authoritative Dictionary of
IEEE Standards Terms, Seventh Edition, [B10] should be referenced for terms not defined in this clause.
4.1 corollary: a semantic and a syntactical representation that are correlated by a unique code.
4.2 -tuple: a component of a relation; e.g., a 2-tuple has two relational components.
4.3 unique: nonredundant.
5. Symbols (and abbreviated terms)
API application program interface
ASN.1 Abstract Syntax Notation One (ISO/IEC 8824)
BAEP brainstem acoustic evoked potential
BCC bedside communication controller
BER basic encoding rules (ISO/IEC 8825-1).
CMDISE communication medical device information service element (CEN ENV 13735
[B5])
CMIP Common Management Information Protocol (ISO/IEC 9596-1)
CMIP* Common Management Information Protocol using ISO/IEEE 11073 MDDL/
MDER
CNS central nervous system
CEN publications are available from the European Committee for Standardization (CEN), 36, rue de Stassart, B-1050 Brussels, Bel-
gium (http://www.cenorm.be).
IEEE publications are available from the Institute of Electrical and Electronics Engineers, Inc., 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://www.standards.ieee.org/).
ISO/IEC documents can be obtained from the ISO office, 1 rue de Varembé, Case Postale 56, CH-1211, Genève 20, Switzerland/
Suisse (http://www.iso.ch/) and from the IEC office, 3 rue de Varembé, Case Postale 131, CH-1211, Genève 20, Switzerland/Suisse
(http://www.iec.ch/). ISO/IEC publications are also available in the United States from the Sales Department, American National Stan-
dards Institute, 25 West 43rd Street, 4th Floor, New York, NY 10036, USA (http://www.ansi.org/).
The numbers in brackets correspond to the numbers of the bibliography in Annex C.
2 Copyright © 2004 ISO/IEEE. All rights reserved.

PART 10101: NOMENCLATURE ISO/IEEE 11073-10101:2004(E)
CSF cerebrospinal fluid
CVS cardiovascular system
DCC device communication controller
DIM domain information model, as defined in vital signs information representation
(VITAL), interoperability of patient-connected medical devices (INTERMED),
and medical device data language (MDDL) (ISO/IEEE 11073-10201 )
ECG electrocardiogram or electrocardiograph
ECoG electrocochleograph
EEG electroencephalogram or electroencephalograph
EMG electromyogram or electromyograph
EOG electrooculogram
ERG electroretinogram or electroretinograph
FEF file exchange format (CEN/TC251/PT-40 [B7])
FFT fast Fourier transform
FSM finite state machine
®7
HL7 Health Level Seven
ICU intensive care unit
ID identifier
INTERMED interoperability of patient-connected medical devices (CEN ENV 13735 [B5])
LLAEP long latency acoustic evoked potential
MDAP medical device application profile (The acronym MDAP may be substituted for the
phrase ISO/IEEE 11073-20000 family of standards.”)
MDC medical device communication
MDDL medical device data language (The acronym MDDL may be substituted for the
phrase ISO/IEEE 11073-10000 family of standards.”)
MDER medical device encoding rules, as defined in medical device application profile
(MDAP)
MDIB medical data information base, as defined in ISO/IEEE 11073-10201
MDS medical device system, an abstraction for a medical device (ISO/IEEE 11073-
10201)
MIB management information base
MLAEP middle latency acoustic evoked potential
NCS nerve conductens study
NOS not otherwise specified
OO object-oriented
OID object identifier
PCA patient-controlled analgesia
PDU protocol data unit (also referred to as a message; by convention, the term PDUs is
used in text to indicate multiplicity)
PFC physiological function code, which represents a physiological concept such as
heart rate, blood pressure, etc.
POC point of care or point-of-care
SCADA supervisory control and data acquisition
SCO service and control object
The DIM was originally defined in CEN ENV 13734 [B4] and CEN ENV 13735 [B5], which are now superseded by ISO/IEEE
11073-10201.
HL7 is a registered trademark of Health Level Seven, Inc. (www.hl7.org).
SCP-ECG Standard Communications Protocol for Computer-Assisted Electrocardiography
(CEN ENV 1064 [B1])
SEP somatosensory evoked potential (also systolic ejection period in the context of
haemodynamic monitoring measurements)
®8
SNOMED Systematized Nomenclature of Medicine
VEP visual evoked potential
VMD virtual medical device; an abstraction of a medical device modality; e.g., a vital
signs monitor medical device system (MDS) might comprise electrocardiogram
(ECG), blood pressure, temperature, and other related VMDs (ISO/IEEE 11073-
10201)
VMO virtual medical object (ISO/IEEE 11073-10201)
VMS virtual medical system (ISO/IEEE 11073-10201)
VITAL vital signs information representation (CEN ENV 13734 [B4])
0x hexadecimal encoding; e.g., the notation 0x0001 implies a 16-bit code with a deci-
mal value of 1
6. Application
Nomenclature in this standard is primarily intended to be used in protocol data units (PDUs) as values of
fields, typically object-oriented attributes, which specify particular alternatives among a related semantic
set. The following are the most common field types.
— Managed object class ID, e.g., MDS [medical device system], VMS [virtual medical system], VMD
[virtual medical device], VMO [virtual medical object], Channel, Metric, Alert, Scanner, SCO [ser-
vice and control object], etc.
— Event type ID, e.g., a numerical observation type of event report.
— Attribute ID: various attributes in the domain information model (DIM)
— Type ID: in general, a concept not covered by a class definition per se, but by a well-known or
commonly used type of a class, e.g., a VMD (e.g., ventilator, gas analyzer), Metric object class
physiological function code (PFC) (e.g., heart rate, cerebral profusion pressure), or the body
site of a measurement (e.g., left toe).
— State: mode, status or finite state machine (FSM) state, e.g., associated.
— Dimension: unit of measurement, e.g., deciliters per hour [dl/h].
— Indication: alarm, e.g., asystole, INOP (e.g., malfunction), or advisory (e.g., check
calibration).
— Action type ID, e.g., activate.
— External nomenclature ID, e.g., Systematized Nomenclature for Medicine (SNOMED).
Technically, information is initially defined in an abstract syntax, e.g., Abstract Syntax Notation One
(ASN.1) or medical device data language (MDDL), and then mapped to and interchanged through a transfer
syntax, e.g., basic encoding rules (BER) or medical device encoding rules (MDER), typically for efficiency
in the form of integers. However, abstract syntax languages are generally unsuitable for high-precision
human understanding, especially of medical terms. As a result, both semantic and syntactical definitions are
needed; as covered in Clause 7 and Clause 8.
7. Semantics
Clause 7 establishes specification guidelines. Refer to Annex A for the detailed specification.
SNOMED is a registered trademark of the College of American Pathologists; Norfield, IL; (800) 323-4040 (http://www.cap.org).
4 Copyright © 2004 ISO/IEEE. All rights reserved.

PART 10101: NOMENCLATURE ISO/IEEE 11073-10101:2004(E)
7.1 Attribution
Nomenclature semantics are represented as a set of attributes, as shown in Table 1.
Table 1—Nomenclature attributes
Attribute Description/Definition Purpose Interpretability Presence
Systematic, An organization of differ- Formal or semiformal but Shall be Manda-
or DIM entiating, relational human-readable derivation unambiguous tory
name descriptors; see Table 2
and Table 3
Common A brief description of the Human-readable identifica- Should be Optional
term name tion or efficient lookup unambiguous
Acronym An abbreviated form of the Mnemonic or parametric Should be Optional
name abbreviation unambiguous
Description/ A long, or sentence, form Human-readable and as Shall be unambigu- Manda-
Definition of the name understandable as possible ous with the excep- tory
tion of synonyms
Reference ID A symbolic, programmatic Development of application Shall be Manda-
form of the term program interfaces (APIs) unambiguous tory
Code [Alpha]numeric identifier Human- and machine-read- Shall be unique, but Manda-
able and efficiently process- context-sensitive tory
able by machines parts are permitted;
see 7.2
Others As appropriate for the semantic and as specified in the detailed tables in Annex A. For example, a
Reference ID, or corollary to the programmatic form, may be used in some cases to facilitate table
lookup.
Refer to Table 2 for an example pertaining to medical device typology and to Table 3 for a partial derivation
of the systematic name used for this partition. As is shown in Table 3, the systematic name is an -tuple
of a base concept and a series of differentiating criteria, and the value of the systematic name is a string sep-
arated by ”|” delimiters. [A null indicates not otherwise specified (NOS).]
Table 2—Attribution example
Systematic name Common term Description/Definition Code
Analyzer
Analyzer | | | Generic analyzer Instrument that analyzes acquired patient 4100
information
Analyzer | Concentration [Sat] | Blood SpO monitor Instrument that derives the % of arterial 4104
| O and pulse rate parameters (blood flow)
7.2 Coding
Several coding methods are used to promote interoperability.
Table 3—Systematic name derivation—medical device type example
Differentiating criteria
Base concept
st nd rd
1 2 3
Analyzer, Concentration, Airway, Nonspecific,
Filter, Electrical Potential, Blood, MDS,
Calculator, Flow, Body, VMD,
… … … Channel
7.2.1 Context-sensitivity
For processing efficiency, especially bandwidth conservation, some nomenclature codes are defined as
fixed-length integer 2-tuples, consisting of a code block number and a term code (within the code block).
Provided that the code block context can be properly mapped, e.g., by implicit syntactical parsing, the pro-
cessor requires only the term code to correlate the semantic, in which case the term code is context-sensitive
with respect to the code block, whereas the 2-tuple is context-free.
For additional processing efficiency, code block numbers and term codes are mapped to 16-bit and 32-bit
words, as follows.
**16
[context-free] Nomenclature Code == (Code Block number * 2 ) + [context-
sensitive] Term Code,
where
**16
Term Code has the range 2 .
For example, the context-free nomenclature code for a term in code block number 1 whose term code=4100
**16
is equal to (( 1 * 2 ) + 4100) = 65536 + 4100 = 69636 (which uniquely identifies the SpO monitor term
in Table 2).
Refer to Figure 1 for an illustration of the relationship between code block number and term codes.
Figure 1—Context-sensitive coding illustration
6 Copyright © 2004 ISO/IEEE. All rights reserved.

PART 10101: NOMENCLATURE ISO/IEEE 11073-10101:2004(E)
Code interpretation may also be context-sensitive with respect to nomenclature versions; however, nomen-
clature revision coding is outside of the scope of this standard and should be provided by application PDUs
during device association.
7.2.2 Grouping
Term codes may be grouped into code ranges as follows:
— A partition is a group of semantics that are assigned to a contiguous term code range within a code
block and that have a categorical relationship. For example, object classes, attributes, and notifica-
tions are partitions of the object-oriented code block. Partitions are prefixed as high-order bit masks
that are computed by offset, typically in multiples of binary orders of magnitude, e.g., 0x1000,
0x2000, etc.
— Code blocks or partitions may be designated as public and private. Syntactical conformance
shall be mandatory for all code blocks and partitions, but semantic conformance for private
code blocks or partitions shall not be mandatory. By convention, each code block should allo-
cate private partitions consistently; the range 0xF000–0xFFFF is recommended.
— A discriminator is a group of related semantics assigned to a contiguous code range that have a reg-
ular relationship, e.g., maximum/minimum/mean or systolic/diastolic/mean. Discriminators are
embedded as low-order bit code that are computed by relative offset to a base term.
For example, Table 1 is an example of a 2-bit device discriminator, in which the relative off-
sets 0–3 correspond, respectively, with the following semantics:
— NOS, offset=0),
— MDS class [offset=1],
— VMD class [offset=2], and
— Channel class [offset=3], respectively.
8. Syntax
Nomenclature codes are intended to be mapped to machine-processable forms using various protocols (e.g.,
ISO/IEEE 11073-20101) and program (e.g., C++) presentation forms. However, because it is impractical to
do all mappings, this standard shall provide mappings to a set of nominal forms, as follows:
— Transfer: numeric form suitable for use in transfer syntaxes; refer to 8.1.
...


INTERNATIONAL ISO/IEEE
STANDARD 11073-10101
First edition
2004-12-15
Health informatics — Point-of-care medical
device communication —
Part 10101:
Nomenclature
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 10101: Nomenclature
Reference number
©
ISO/IEEE 2004
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

This CD-ROM contains the publication ISO/IEEE 11073-10101:2004 in portable document format (PDF),
which can be viewed using Adobe® Acrobat® Reader.
Adobe and Acrobat are trademarks of Adobe Systems Incorporated.

This ISO/IEEE document is an International Standard and is copyright-protected by ISO and the IEEE. Except as permitted under the
applicable laws of the user’s country, neither this ISO/IEEE standard nor any extract from it may be reproduced, stored in a retrieval
system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission
being secured.
Requests for permission to reproduce should be addressed to either ISO
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

Loading comments...