SIST EN ISO 11073-20101:2005

Health informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004)

To provide a domain model for the series of 11073 Health informatics - Point-of-care generalized application profiles.

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 20101: Profils d'applications - Norme de base (ISO/IEEE 11073-20101:2004)

Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe – 20101. del: Profili aplikacije – Temeljni standard (ISO/IEEE 11073-20101:2004)

General Information

• Status: Published
• Publication Date: 31-Oct-2005
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Nov-2005
• Due Date: 01-Nov-2005
• Completion Date: 01-Nov-2005
• Ref Project: EN ISO 11073-20101:2005 - Health informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11073-20101:2005
01-november-2005
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe –
20101. del: Profili aplikacije – Temeljni standard (ISO/IEEE 11073-20101:2004)
Health informatics - Point-of-care medical device communication - Part 20101:
Application profiles - Base standard (ISO/IEEE 11073-20101:2004)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 20101: Profils d'applications - Norme de base (ISO/IEEE 11073-20101:2004)
Ta slovenski standard je istoveten z: EN ISO 11073-20101:2005
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-20101:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-20101:2005

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SIST EN ISO 11073-20101:2005
EUROPEAN STANDARD
EN ISO 11073-20101
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2005
ICS 35.240.80

English Version
Health informatics - Point-of-care medical device communication
- Part 20101: Application profiles - Base standard (ISO/IEEE
11073-20101:2004)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation patientennaher
médicaux sur le site des soins - Partie 20101: Profils medizinischer Geräte - Teil 20101: Anwendungsprofil -
d'applications - Norme de base (ISO/IEEE 11073- Basisnorm
20101:2004)
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.
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 11073-20101:2005: E
worldwide for CEN national Members.

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SIST EN ISO 11073-20101:2005
EN ISO 11073-20101:2005 (E)






Foreword



The text of ISO/IEEE 11073-20101:2004 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 11073-20101:2005 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 11073-20101:2004 has been approved by CEN as EN ISO 11073-
20101:2005 without any modifications.

2

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SIST EN ISO 11073-20101:2005
INTERNATIONAL
ISO/IEEE
STANDARD
11073-20101
First edition
2004-12-15
Health informatics — Point-of-care
medical device communication —
Part 20101:
Application profiles — Base standard
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 20101: Profils d'applications — Norme de base
Reference number
ISO/IEEE 11073-20101:2004(E)
© ISO/IEEE 2004

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SIST EN ISO 11073-20101:2005

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SIST EN ISO 11073-20101:2005
ISO/IEEE 11073-20101:2004(E)
Health informatics — Point-of-care medical
device communication —
Part 20101:
Application profiles — Base standard
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 11073-20101:2005
ISO/IEEE 11073-20101:2004(E)
PDF disclaimer
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inform the ISO Central Secretariat or the IEEE at the address given below.
Abstract: The scope of this standard is upper layer [i.e., the International Organization for
Standardization (ISO’s) open systems interconnection (OSI) application, presentation layer, and
session layer] services and protocols for information exchange under the ISO/IEEE 11073
standards for medical device communications (MDC). This standard is the base standard of the
ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the
Committee for European Normalization (CEN) and the ISO.
Keywords: abstract syntax, alarm, alert, communication, control, information model, medical
device, object-oriented, point-of-care, POC, services
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ii Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-20101:2005
ISO/IEEE 11073-20101:2004(E)
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Copyright © 2004 ISO/IEEE. All rights reserved. iii

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SIST EN ISO 11073-20101:2005

ISO/IEEE 11073-20101:2004(E)
iv Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-20101:2005
ISO/IEEE 11073-20101:2004(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
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,
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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.
ISO/IEEE 11073-20101:2004(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 11073-20101:2005

ISO/IEEE 11073-20101:2004(E)
IEEE Introduction
This introduction is not part of ISO/IEEE 11073-20101:2004(E), Health informatics — Point-of-care medical device
communication — Part 20101: Application profiles — Base standard.
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://
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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 11073-20101:2005
ISO/IEEE 11073-20101:2004(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 Michael Krämer Lief Rystrøm
Francis Cantraine Alberto Macerata Michael Spicer
Todd H. Cooper Simon Meij Lars Steubesand
Michael Flötotto Angelo Rossi Mori Andrew Sutton
Ken Fuchs Thomas Norgall Alpo Värri
Kai Hassing Thomas Penzel Jan Wittenber
Gunther Hellmann Francesco Pinciroli Paul Woolman
Ron Kirkham Rick Revello Christoph Zywietz
Melvin Reynolds
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Thomas Canup Kai Hassing Melvin Reynolds
Michael Chilbert Tom Kannally Ricardo Ruiz-Fernández
Todd H. Cooper Robert Kennelly Michael Spicer
James (Bob) Davis Randy Krohn M. Michael Shabot
George Economakos Yeou-Song Lee Lars Steubesand
Grace Esche Daniel Nowicki Jan Wittenber
Kenneth Fuchs Gin-Shu Young
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
H. Stephen Berger Raymond Hapeman T. W. Olsen
Mark D. Bowman Richard J. Holleman Ronald C. Petersen
Richard H. Hulett Gary S. Robinson
Joseph A. Bruder
Lowell G. Johnson Frank Stone
Bob Davis
Joseph L. Koepfinger* Malcolm V. Thaden
Roberto de Boisson
Hermann Koch Doug Topping
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 11073-20101:2005

ISO/IEEE 11073-20101:2004(E)
Contents
1. Overview. 1
1.1 Scope. 2
1.2 Purpose. 2
1.3 Goals . 2
1.4 Audience . 2
2. References. 2
3. Definitions and abbreviations . 4
3.1 Definitions . 4
3.2 Acronyms and abbreviations .4
4. Conventions . 6
5. Rationale . 6
5.1 Communication model. 6
5.2 Information model . 7
6. Communication model. 8
6.1 General. 8
6.2 ACSE protocol . 10
6.2.1 General. 10
6.2.2 ACSE services . 10
6.2.3 ACSE ASN.1 message definition . 12
6.2.4 ACSE user information fields. 12
6.3 Session-layer protocol. 12
6.3.1 General. 12
6.3.2 Session-layer services . 12
6.3.3 Session-layer message definitions . 13
6.4 Presentation-layer protocol . 13
6.4.1 General. 13
6.4.2 Presentation-layer services . 14
6.4.3 Presentation-layer messages . 14
6.5 ROSE protocol. 14
6.5.1 General. 14
6.5.2 ROSE services . 14
6.5.3 ROSE message definitions. 14
6.6 CMDISE protocol (CMDIP). 15
6.6.1 General. 15
6.6.2 CMDISE services . 15
6.6.3 CMDIP message definitions . 15
6.6.4 SNTP. 15
7. Information model . 16
7.1 Object model. 16
7.2 Format model. 16
viii Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-20101:2005
ISO/IEEE 11073-20101:2004(E)
7.2.1 Syntax . 16
7.2.2 Compatibility . 16
8. Conformance. 17
8.1 Scope. 17
8.2 Object identifier administration .17
8.3 MDAP subset conformance . 17
8.4 Implementation conformance . 17
Annex A (normative) Medical device encoding rules (MDER). 18
Annex B (normative) Allocation of identifiers. 29
Annex C (informative) Time synchronization. 32
Annex D (informative) Dynamic model. 33
Annex E (normative) Abstract syntax . 38
Annex F (informative) PDU examples . 59
Annex G (informative) Specialization of ASN.1.72
Annex H (informative) Compatibility cases. 75
Annex I (informative) Bibliography . 77
Copyright © 2004 ISO/IEEE. All rights reserved. ix

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SIST EN ISO 11073-20101:2005

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SIST EN ISO 11073-20101:2005
Health informatics — Point-of-care medical
device communication —
Part 20101:
Application profiles — Base standard
1. Overview
This standard is divided into eight clauses, as follows:
— Clause 1 provides the scope of this standard.
— Clause 2 lists references to other standards that are useful in applying this standard.
— Clause 3 provides definitions and abbreviations.
— Clause 4 provides conventions.
— Clause 5 provides the rationale for this standard.
— Clause 6 provides a communication, i.e., protocol and service, model.
— Clause 7 provides an information, i.e., object, model.
— Clause 8 provides conformance requirements.
This standard also contains nine annexes, as follows:
— Annex A defines the specialized medical device encoding rules (MDER). (normative)
— Annex B describes the allocation of object identifiers. (normative)
— Annex C provides references to time synchronization protocols applied by this standard.
— Annex D includes state transition diagrams as part of the dynamic model.
— Annex E provides abstract syntax, which offers extensions to leveraged standards, such as minimal
open systems interconnection (mOSI), that are specific to this standard. (normative)
— Annex F includes examples of a number of protocol data unit (PDU) examples.
— Annex G describes a specialization of Abstract Syntax Notation One (ASN.1).
— Annex H deals with compatibility of ASN.1 between the
...