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

To provide a nomenclature for the series of 11073 Health informatics - Point-of-care medical device communication standards.

Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil 10101: Nomenklatur

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 10101: Nomenclature (ISO/IEEE 11073-10101:2004)

Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe – 10101. del: Nomenklatura (ISO/IEEE 11073-10101:2004)

General Information

Status
Withdrawn
Publication Date
31-Oct-2005
Withdrawal Date
08-Oct-2020
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
07-Oct-2020
Due Date
30-Oct-2020
Completion Date
09-Oct-2020

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SLOVENSKI STANDARD
SIST EN ISO 11073-10101:2005
01-november-2005
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe –
10101. del: Nomenklatura (ISO/IEEE 11073-10101:2004)
Health informatics - Point-of-care medical device communication - Part 10101:
Nomenclature (ISO/IEEE 11073-10101:2004)

Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil

10101: Nomenklatur

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -

Partie 10101: Nomenclature (ISO/IEEE 11073-10101:2004)
Ta slovenski standard je istoveten z: EN ISO 11073-10101:2005
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10101:2005 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-10101:2005
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SIST EN ISO 11073-10101:2005
EUROPEAN STANDARD
EN ISO 11073-10101
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2005
ICS 35.240.80; 01.040.35
English Version
Health informatics - Point-of-care medical device communication
- Part 10101: Nomenclature (ISO/IEEE 11073-10101:2004)

Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation patientennaher

médicaux sur le site des soins - Partie 10101: medizinischer Geräte - Teil 10101: Nomenklatur

Nomenclature (ISO/IEEE 11073-10101:2004)
This European Standard was approved by CEN on 16 August 2005.

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 Central Secretariat 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 Central Secretariat has the same status as the official

versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,

Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,

Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10101:2005: E

worldwide for CEN national Members.
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SIST EN ISO 11073-10101:2005
EN ISO 11073-10101:2005 (E)
Foreword

The text of ISO/IEEE 11073-10101:2004 has been prepared by Technical Committee ISO/TC

215 "Health informatics” of the International Organization for Standardization (ISO) and has

been taken over as EN ISO 11073-10101:2005 by 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 February 2006, and conflicting national

standards shall be withdrawn at the latest by February 2006.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of

the following countries are bound to implement this European Standard: Austria, Belgium,

Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,

Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10101:2004 has been approved by CEN as EN ISO 11073-
10101:2005 without any modifications.
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SIST EN ISO 11073-10101:2005
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 11073-10101:2004(E)
© ISO/IEEE 2004
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SIST EN ISO 11073-10101:2005
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)
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
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)
PDF disclaimer

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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

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ii Copyright © 2004 ISO/IEEE. All rights reserved.
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)

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Copyright © 2004 ISO/IEEE. All rights reserved. iii
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)
iv Copyright © 2004 ISO/IEEE. All rights reserved.
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)
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

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standardization.

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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.

ISO/IEEE 11073-10101:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in

Medicine and Biology Society.
Copyright © 2004 ISO/IEEE. All rights reserved. v
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)
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

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conducting inquiries into the legal validity or scope of those patents that are brought to its attention.

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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.
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)
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
Copyright © 2004 ISO/IEEE. All rights reserved. vii
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)
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.
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SIST EN ISO 11073-10101:2005
ISO/IEEE 11073-10101:2004(E)

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...................................
...

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