SIST EN ISO 11073-10201:2020

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

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SIST EN ISO 11073-10201:2020

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SIST EN ISO 11073-10201:2020


EN ISO/IEEE 11073-
EUROPEAN STANDARD
10201
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2020
ICS 35.240.80 Supersedes EN ISO 11073-10201:2005
English Version

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

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

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

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SIST EN ISO 11073-10201:2020
EN ISO/IEEE 11073-10201:2020 (E)
Contents Page
European foreword . 3

2

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

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SIST EN ISO 11073-10201:2020

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SIST EN ISO 11073-10201:2020
INTERNATIONAL ISO/IEEE
STANDARD 11073-
10201
Second edition
2020-04
Health informatics — Device
interoperability —
Part 10201:
Point-of-care medical device
communication — Domain
information model
Informatique de santé — Interopérabilité des dispositifs —
Partie 10201: Communication entre dispositifs médicaux sur le site
des soins — Modèle d'informations du domaine
Reference number
ISO/IEEE 11073-10201:2020(E)
©
IEEE 2019

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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© IEEE 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Email: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2019 – All rights reserved

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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)
Foreword
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different types of ISO documents should be noted (see www.iso.org/directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE‐SA) Standards Board. The IEEE develops its
standards through a consensus development process, approved by the American National Standards
Institute, which brings together volunteers representing varied viewpoints and interests to achieve the
final product. Volunteers are not necessarily members of the Institute and serve without compensation.
While the IEEE administers the process and establishes rules to promote fairness in the consensus
development process, the IEEE does not independently evaluate, test, or verify the accuracy of any of the
information contained in its standards.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
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see www.iso.org/iso/foreword.html.
ISO/IEEE 11073‐10201 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073‐10201‐2018) and drafted in accordance with its
editorial rules. It was adopted, under the “fast‐track procedure” defined in the Partner Standards
Development Organization cooperation agreement between ISO and IEEE, by Technical Committee
ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO/IEEE 11073‐10201:2004), which has been
technically revised.
A list of all parts in the ISO/IEEE 11073 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
© IEEE 2019 – All rights reserved iii

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SIST EN ISO 11073-10201:2020

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SIST EN ISO 11073-10201:2020
IEEE Std 11073-10201™-2018
(Revision of
IEEE Std 11073-10201-2004)
Health informatics—Point-of-care medical device communication

Part 10201: Domain Information Model
Sponsor

IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society


Approved 5 December 2018

IEEE-SA Standards Board

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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care medical
device communication, an abstract, object-oriented domain information model that specifies the
structure of exchanged information, as well as the events and services that are supported by
each type of object, is provided in this standard. All data structure elements are specified using
abstract syntax (ASN.1) and may be applied to many different implementation technologies,
transfer syntaxes, and application service models. Core subjects include medical, alert, system,
patient, control, archival, communication, and extended services. Model extensibility is supported,
and a conformance model and statement template is provided.
Keywords: abstract syntax, alarm, alert, ASN.1, DIM, domain information model, IEEE 11073-
10201™, information model, medical device communications, medical information bus, MIB,
object-oriented, patient, POC, point-of-care, remote control
•
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of the publisher.
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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)
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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)
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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)
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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)
Participants
At the time this IEEE standard was completed, the Point-of-Care Devices Working Group had the
following membership:
John Rhoads, Chair
Michael Faughn, Subgroup Chair
Bjoern Anderson David Gregorczyk Tracy Rausch
Malcolm Clarke Kai Hassing Stefan Schlichting
Todd Cooper John Hatcliff Paul Schluter
Chris Courville Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Frank Golatowski Joerg-Uwe Meyer Jan Wittenber
Stephan Poehlsen
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen Kai Hassing Stefan Schlichting
Michael Bayer Werner Hoelzl Paul Schluter
Keith Chow Noriyuki Ikeuchi Walter Struppler
Malcolm Clarke Atsushi Ito Ganesh Subramanian
Michael Faughn Stefan Karl Thomas Tullia
David Fuschi Piotr Karocki Jan Wittenber
David Gregorczyk Martin Kasparick Oren Yuen
Randall Groves H. Moll Daidi Zhong
John Rhoads
When the IEEE-SA Standards Board approved this standard on 5 December 2018, it had the following
membership:
Jean-Philippe Faure, Chair
Gary Hoffman, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Ted Burse Xiaohui Liu Robby Robson
Guido R. Hiertz Kevin Lu Dorothy Stanley
Christel Hunter Daleep Mohla Mehmet Ulema
Joseph L. Koepfinger* Andrew Myles Phil Wennblom
Thomas Koshy Paul Nikolich Philip Winston
Hung Ling Ronald C. Petersen Howard Wolfman
Dong Liu Annette D. Reilly Jingyi Zhou
*Member Emeritus
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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)

Introduction
This introduction is not part of IEEE Std 11073-10201-2018, Health informatics—Point-of-care medical device
communication—Part 10201: Domain Information Model.
ISO/IEEE 11073 standards enable communication between different medical devices and between medical
devices and other IT systems for information and for command and control. The primary goals are to:
 Provide real-time plug-and-play interoperability for patient-connected medical devices
 Facilitate the efficient exchange of patient related data and medical device related data, acquired at
the point-of-care (POC), in all health care environments
“Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or
processed in fractions of a second.
“Plug-and-play” means that when a device or system is connected to another device or system, detection,
configuration, and the initiation of communication all occur automatically andwithout any other human
interaction.
“Efficient exchange of medical device data” means that information that is captured at the POC (e.g.,
patient vital signs data) can be archived, retrieved, and processed by many different types of applications
without extensive software and equipment support, and without needless loss of information. This standard
is especially targeted at acute and continuing care devices, such as patient monitors, ventilators, infusion
pumps, ECG devices, etc. It is a member of a family of standards that can be layered together to provide
connectivity optimized for the specific devices being interfaced.


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SIST EN ISO 11073-10201:2020
ISO/IEEE 11073-10201:2020(E)

Contents
1. Scope . 9
2. Normative references . 9
3. Definitions, acronyms, and abbreviations . 10
3.1 Definitions . 10
3.2 Abbreviations and acronyms . 13
4. General requirements . 14
5. Domain information model (DIM) . 15
5.1 General . 15
5.2 Package diagram–Overview . 18
5.3 Model for the Medical Package . 19
5.4 Model for the Alert Package . 23
5.5 Model for the System Package . 25
5.6 Model for the Control Package . 27
5.7 Model for the ExtendedServices Package . 30
5.8 Model for the Communication Package . 33
5.9 Model for the Archival Package .
...