SIST EN ISO 11073-10201:2005

SLOVENSKI STANDARD
SIST EN ISO 11073-10201:2005
01-november-2005
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe –
10201. del: Informacijski model domene (ISO/IEEE 11073-10201:2004)
Health informatics - Point-of-care medical device communication - Part 10201: Domain
information model (ISO/IEEE 11073-10201:2004)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
10201: Bereichs-Informationsmodell
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 10201: Modele d'information du domaine (ISO/IEEE 11073-10201:2004)
Ta slovenski standard je istoveten z: EN ISO 11073-10201:2005
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10201:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-10201:2005

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SIST EN ISO 11073-10201:2005
EUROPEAN STANDARD
EN ISO 11073-10201
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2005
ICS 35.240.80

English Version
Health informatics - Point-of-care medical device communication
- Part 10201: Domain information model (ISO/IEEE 11073-
10201:2004)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation patientennaher
médicaux sur le site des soins - Partie 10201: Modèle medizinischer Geräte - Teil 10201: Bereichs-
d'information du domaine (ISO/IEEE 11073-10201:2004) Informationsmodell
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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 11073-10201:2005: E
worldwide for CEN national Members.

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SIST EN ISO 11073-10201:2005
EN ISO 11073-10201:2005 (E)






Foreword



The text of ISO/IEEE 11073-10201:2004 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 11073-10201:2005 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 11073-10201:2004 has been approved by CEN as EN ISO 11073-
10201:2005 without any modifications.

2

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SIST EN ISO 11073-10201:2005
INTERNATIONAL
ISO/IEEE
STANDARD
11073-10201
First edition
2004-12-15
Health informatics — Point-of-care
medical device communication —
Part 10201:
Domain information model
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 10201: Modèle d'information du domaine
Reference number
ISO/IEEE 11073-10201:2004(E)
© ISO/IEEE 2004

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SIST EN ISO 11073-10201:2005

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SIST EN ISO 11073-10201:2005
ISO/IEEE 11073-10201:2004(E)
Health informatics — Point-of-care
medical device communication —
Part 10201:
Domain information model
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 11073-10201:2005

ISO/IEEE 11073-10201:2004(E)
PDF disclaimer
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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 (MDC), this standard provides 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 object. All 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 conform-
ance model and statement template is provided.
Keywords: abstract syntax, alarm, alert, ASN.1, information model, medical device communications, medi-
cal information bus, MIB, point-of-care, POC, object-oriented, patient, remote control
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ii Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-10201:2005
ISO/IEEE 11073-10201:2004(E)
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Copyright © 2004 ISO/IEEE. All rights reserved. iii

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SIST EN ISO 11073-10201:2005

ISO/IEEE 11073-10201:2004(E)
iv Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-10201:2005
ISO/IEEE 11073-10201:2004(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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been established has the right to be represented on that committee. International organizations,
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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 11073-10201:2004(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 11073-10201:2005

ISO/IEEE 11073-10201:2004(E)
IEEE Introduction
This introduction is not part of ISO/IEEE 11073-10201:2004(E), Health informatics — Point-of-care medical device
communication — Part 10201: Domain information model.
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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Errata, if any, for this and all other standards can be accessed at the following URL: http://
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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 11073-10201:2005
ISO/IEEE 11073-10201:2004(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
Wolfgang Bleicher Jörg Kampmann Melvin Reynolds
Francis Cantraine Ron Kirkham Paul Rubel
Thomas Canup Michael Krämer Lief Rystrom
Mats Cardell Alberto Macerata Paul Schluter
Michael Chilbert Simon Meij Michael Spicer
Michael Flötotto Angelo Rossi Mori Alpo Värri
Ken Fuchs Thomas Norgall Jan Wittenber
Kai Hassing Daniel Nowicki Paul Woolman
Gunther Hellmann Thomas Penzel Christoph Zywietz
Francesco Pinciroli
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
Kai Hassing
Michael Chilbert Michael Spicer
Keith Chow Tom Kannally Richard Schrenker
Todd H. Cooper Robert Kennelly M. Michael Shabot
Randall Krohn
Grace Esche 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
T. W. Olsen
H. Stephen Berger Raymond Hapeman
Ronald C. Petersen
Mark D. Bowman Richard J. Holleman
Gary S. Robinson
Joseph A. Bruder Richard H. Hulett
Frank Stone
Lowell G. Johnson
Bob Davis
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 11073-10201:2005

ISO/IEEE 11073-10201:2004(E)
Contents
1. Scope. 1
2. Normative references. 1
3. Definitions . 4
4. Abbreviations and acronyms . 8
5. General requirements. 9
6. DIM. 9
6.1 General. 9
6.1.1 Modeling concept . 9
6.1.2 Scope of the DIM. 11
6.1.3 Approach. 11
6.1.4 Extension of the model . 12
6.2 Package diagram–overview . 12
6.3 Model for the Medical Package . 12
6.3.1 VMO (i.e., virtual medical object). 14
6.3.2 VMD (i.e., virtual medical device) object . 14
6.3.3 Channel object . 15
6.3.4 Metric object. 15
6.3.5 Numeric object. 15
6.3.6 Sample Array object . 15
6.3.7 Real Time Sample Array object. 15
6.3.8 Time Sample Array object. 15
6.3.9 Distribution Sample Array object. 16
6.3.10 Enumeration object. 16
6.3.11 Complex Metric object . 16
6.3.12 PM-Store (i.e., persistent metric) object. 16
6.3.13 PM-Segment object. 16
6.4 Model for the Alert Package.17
6.4.1 Alert object . 17
6.4.2 Alert Status object. 18
6.4.3 Alert Monitor object . 18
6.5 Model for the System Package . 19
6.5.1 VMS (i.e., virtual medical system) object . 19
6.5.2 MDS object. 19
6.5.3 Simple MDS object. 20
6.5.4 Hydra MDS object. 20
6.5.5 Composite Single Bed MDS object. 20
6.5.6 Composite Multiple Bed MDS object . 20
6.5.7 Log object . 20
6.5.8 Event Log object. 20
6.5.9 Battery object. 20
6.5.10 Clock object . 20
6.6 Model for the Control Package. 21
6.6.1 SCO. 22
6.6.2 Operation object. 22
6.6.3 Select Item Operation object. 22
viii Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-10201:2005
ISO/IEEE 11073-10201:2004(E)
6.6.4 Set Value Operation object. 23
6.6.5 Set String Operation object. 23
6.6.6 Toggle Flag Operation object . 23
6.6.7 Activate Operation object . 23
6.6.8 Limit Alert Operation object. 23
6.6.9 Set Range Operation object . 23
6.7 Model for the Extended Services Package . 24
6.7.1 Scanner object. 24
6.7.2 CfgScanner (i.e., configurable scanner) object. 25
6.7.3 EpiCfgScanner (i.e., episodic configurable scanner) object. 25
6.7.4 PeriCfgScanner (i.e., periodic configurable scanner) object . 25
6.7.5 FastPeriCfgScanner (i.e., fast periodic configurable scanner) object. 26
6.7.6 UcfgScanner (i.e., unconfigurable scanner) object. 26
6.7.7 Context Scanner object . 26
6.7.8 Alert Scanner object. 26
6.7.9 Operating Scanner object. 26
6.8 Model for the Communication Package . 26
6.8.1 Communication Controller object . 27
6.8.2 DCC (i.e., device communication controller) object. 27
6.8.3 BCC (i.e., bedside communication controller) object . 28
6.8.4 Device Interface object . 28
6.8.5 MibElement object. 28
6.8.6 Specialized MibElement object . 28
6.9 Model for the Archival Package . 28
6.9.1 Multipatient Archive object. 29
6.9.2 Patient Archive object. 29
6.9.3 Session Archive object.
...