SIST EN ISO 11073-20701:2020
(Main)Health informatics - Device interoperability - Part 20701: Point-of-care medical device communication - Service oriented medical device exchange architecture and protocol binding (ISO/IEEE 11073-20701:2020)
Health informatics - Device interoperability - Part 20701: Point-of-care medical device communication - Service oriented medical device exchange architecture and protocol binding (ISO/IEEE 11073-20701:2020)
The scope of this standard is a service-oriented medical device architecture and communication protocol
specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that
need to exchange data or safely control networked PoC medical devices. It identifies the functional
components, their communication relationships as well as the binding of the components and
communication relationships to protocol specifications.
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil 20701: Service-Orientierte Architektur und Protokoll für Medizingeräte-Kommunikation (ISO/IEEE 11073-20701:2020)
Informatique de santé - Interopérabilité des dispositifs - Partie 20701: Communication entre dispositifs médicaux sur le site des soins - Architecture d'échange orientée services entre dispositifs médicaux et liaison par protocole (ISO/IEEE 11073-20701:2020)
Le domaine d'application de la présente norme est une spécification d'architecture de dispositifs médicaux et de protocole de communication orientés services pour les systèmes distribués de dispositifs médicaux sur le site des soins (PoC) et les systèmes informatiques médicaux qui doivent échanger des données ou commander en toute sécurité des dispositifs médicaux PoC en réseau. Elle identifie les composants fonctionnels, leurs relations de communication, ainsi que la liaison des composants et des relations de communication avec les spécifications du protocole.
Zdravstvena informatika - Interoperabilnost naprav - 20701. del: Komunikacija medicinskih naprav na mestu oskrbe - Storitveno usmerjena arhitektura in protokol za komunikacijo z medicinskimi napravami (ISO/IEEE 11073-20701:2020)
General Information
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11073-20701:2020
01-junij-2020
Zdravstvena informatika - Interoperabilnost naprav - 20701. del: Komunikacija
medicinskih naprav na mestu oskrbe - Storitveno usmerjena arhitektura in
protokol za komunikacijo z medicinskimi napravami (ISO/IEEE 11073-20701:2020)
Health informatics - Device interoperability - Part 20701: Point-of-care medical device
communication - Service oriented medical device exchange architecture and protocol
binding (ISO/IEEE 11073-20701:2020)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
20701: Service-Orientierte Architektur und Protokoll für Medizingeräte-Kommunikation
(ISO/IEEE 11073-20701:2020)
Informatique de santé - Interopérabilité des dispositifs - Partie 20701: Communication
entre dispositifs médicaux sur le site des soins - Architecture d'échange orientée
services entre dispositifs médicaux et liaison par protocole (ISO/IEEE 11073-
20701:2020)
Ta slovenski standard je istoveten z: EN ISO 11073-20701:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-20701:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11073-20701:2020
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SIST EN ISO 11073-20701:2020
EN ISO 11073-20701
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2020
EUROPÄISCHE NORM
ICS
English Version
Health informatics - Device interoperability - Part 20701:
Point-of-care medical device communication - Service
oriented medical device exchange architecture and
protocol binding (ISO/IEEE 11073-20701:2020)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Kommunikation
- Partie 20701: Communication entre dispositifs patientennaher medizinischer Geräte - Teil 20701:
médicaux sur le site des soins - Architecture d'échange Service-Orientierte Architektur und Protokoll für
orientée services entre dispositifs médicaux et liaison Medizingeräte-Kommunikation (ISO/IEEE 11073-
par protocole (ISO/IEEE 11073-20701:2020) 20701:2020)
This European Standard was approved by CEN on 18 February 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 11073-20701:2020 E
worldwide for CEN national Members.
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SIST EN ISO 11073-20701:2020
EN ISO 11073-20701:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11073-20701:2020
EN ISO 11073-20701:2020 (E)
European foreword
This document (EN ISO 11073-20701:2020) 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 October 2020, and conflicting national standards shall
be withdrawn at the latest by October 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.
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 11073-20701:2020 has been approved by CEN as EN ISO 11073-20701:2020
without any modification.
3
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SIST EN ISO 11073-20701:2020
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SIST EN ISO 11073-20701:2020
INTERNATIONAL ISO/IEEE
STANDARD 11073-
20701
First edition
2020-03
Health informatics — Device
interoperability —
Part 20701:
Point-of-care medical device
communication — Service oriented
medical device exchange architecture
and protocol binding
Informatique de santé — Interopérabilité des dispositifs —
Partie 20701: Communication entre dispositifs médicaux sur le site
des soins — Architecture d'échange orientée services entre dispositifs
médicaux et liaison par protocole
Reference number
ISO/IEEE 11073-20701:2020(E)
©
IEEE 2019
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(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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Institute of Electrical and Electronics Engineers, Inc
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NY 10016-5997, USA
Email: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
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
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collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
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
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
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www.iso.org/iso/foreword.html.
ISO/IEEE 11073-20701 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering
in Medicine and Biology Society (as IEEE Std 11073-20701-2018) 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.
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 11073-20701:2020
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SIST EN ISO 11073-20701:2020
Health informatics—Point-of-care medical device communication
Part 20701: Service-Oriented Medical
Device Exchange Architecture and
Protocol Binding
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 27 September 2018
IEEE-SA Standards Board
---------------------- Page: 11 ----------------------
SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC)
medical device communication, an architecture for service-oriented distributed PoC medical
devices and medical IT systems is defined. This standard defines a binding of the Participant,
Discovery, and Communication Model defined in IEEE Std 11073-10207™ to the profile for
transport over Web Services defined in IEEE Std 11073-20702™. Moreover, a binding to Network
Time Protocol (NTP) and Differentiated Services (DiffServ) is defined for time synchronization
and transport Quality of Service requirements.
Keywords: alert systems, BICEPS, DiffServ, IEEE 11073-20701™, ISO/IEEE 11073, MDPWS,
medical device communication, NTP, patient, point-of-care, remote control, service-oriented
architecture
The Institute of Electrical and Electronics Engineers, Inc.
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PDF: ISBN 978-1-5044-5264-9 STD23381
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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.
2
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
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3
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Translations
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4
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
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5
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Participants
At the time this IEEE standard was completed, the Point of Care Devices Working Group had the following
membership:
Jan Wittenber, Chair
Stefan Schlichting, Subgroup Chair
Bjoern Anderson Frank Golatowski Stephan Poehlsen
Malcolm Clarke David Gregorczyk Tracy Rausch
Todd Cooper Kai Hassing John Rhoads
Chris Courville John Hatcliff Paul Schluter
Michael Faughn Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Joerg-Uwe Meyer
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen Werner Hoelzl Stefan Schlichting
Lyle Bullock Noriyuki Ikeuchi Janek Schumann
Carole Carey Atsushi Ito Sarah Shafqat
Keith Chow Raj Jain Walter Struppler
Sourav Dutta Stefan Karl J. Wiley
Kenneth Fuchs Piotr Karocki Jan Wittenber
David Fuschi Martin Kasparick Oren Yuen
David Gregorczyk Thomas Kurihara Janusz Zalewski
Randall Groves Joerg-Uwe Meyer Daidi Zhong
Beth Pumo
When the IEEE-SA Standards Board approved this standard on 27 September 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
6
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Introduction
This introduction is not part of IEEE Std 11073-20701-2018, Health Informatics—Point-of-care medical device
communication—Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding.
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 medical devices
Facilitate the efficient exchange of vital signs and medical device 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 all the clinician has to do is to make the
connection—the Participants automatically detect, configure, and communicate without 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 received, parsed, and interpreted by many different types of applications
without unnecessary loss of information. The standards are especially targeted at acute, surgical, and
continuing care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, endoscopic
camera system, insufflators, endoscopic light sources, dissectors, etc. They comprise a family of standards
that can be bound to one another to provide optimized connectivity for devices at the Point-of-Care.
Within the context of the ISO/IEEE 11073 family of standards for PoC medical device communication, this
standard defines an architecture for service-oriented distributed PoC medical devices and medical IT
systems. It defines a binding of the Participant, Discovery, and Communication Model defined in
IEEE Std 11073-10207 to the profile for transport over Web Services defined in IEEE Std 11073-20702.
Moreover, a binding to Network Time Protocol (NTP) and Differentiated Services (DiffServ) is defined to
satisfy time synchronization and transport Quality of Service requirements.
7
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Contents
1. Overview . 10
1.1 Scope . 10
1.2 Purpose . 10
2. Normative references . 10
3. Definitions . 11
4. Notational conventions . 15
4.1 XML schema namespaces . 15
5. Introduction . 16
6. Service-oriented medical device exchange architecture . 17
7. Service-oriented device connectivity (SDC) participant model binding . 18
7.1 Coded va
...
SLOVENSKI STANDARD
SIST EN ISO 11073-20701:2020
01-junij-2020
Zdravstvena informatika - Medobratovalnost naprav - 20701. del: Komunikacija
medicinskih naprav na mestu oskrbe - Storitveno usmerjena arhitektura in
protokol za komunikacijo z medicinskimi napravami (ISO/IEEE 11073-20701:2020)
Health informatics - Device interoperability - Part 20701: Point-of-care medical device
communication - Service oriented medical device exchange architecture and protocol
binding (ISO/IEEE 11073-20701:2020)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
20701: Service-Orientierte Architektur und Protokoll für Medizingeräte-Kommunikation
(ISO/IEEE 11073-20701:2020)
Informatique de santé - Interopérabilité des dispositifs - Partie 20701: Communication
entre dispositifs médicaux sur le site des soins - Architecture d'échange orientée
services entre dispositifs médicaux et liaison par protocole (ISO/IEEE 11073-
20701:2020)
Ta slovenski standard je istoveten z: EN ISO 11073-20701:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-20701:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 11073-20701:2020
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SIST EN ISO 11073-20701:2020
EN ISO 11073-20701
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2020
EUROPÄISCHE NORM
ICS
English Version
Health informatics - Device interoperability - Part 20701:
Point-of-care medical device communication - Service
oriented medical device exchange architecture and
protocol binding (ISO/IEEE 11073-20701:2020)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Kommunikation
- Partie 20701: Communication entre dispositifs patientennaher medizinischer Geräte - Teil 20701:
médicaux sur le site des soins - Architecture d'échange Service-Orientierte Architektur und Protokoll für
orientée services entre dispositifs médicaux et liaison Medizingeräte-Kommunikation (ISO/IEEE 11073-
par protocole (ISO/IEEE 11073-20701:2020) 20701:2020)
This European Standard was approved by CEN on 18 February 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 11073-20701:2020 E
worldwide for CEN national Members.
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SIST EN ISO 11073-20701:2020
EN ISO 11073-20701:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11073-20701:2020
EN ISO 11073-20701:2020 (E)
European foreword
This document (EN ISO 11073-20701:2020) 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 October 2020, and conflicting national standards shall
be withdrawn at the latest by October 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.
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 11073-20701:2020 has been approved by CEN as EN ISO 11073-20701:2020
without any modification.
3
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SIST EN ISO 11073-20701:2020
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SIST EN ISO 11073-20701:2020
INTERNATIONAL ISO/IEEE
STANDARD 11073-
20701
First edition
2020-03
Health informatics — Device
interoperability —
Part 20701:
Point-of-care medical device
communication — Service oriented
medical device exchange architecture
and protocol binding
Informatique de santé — Interopérabilité des dispositifs —
Partie 20701: Communication entre dispositifs médicaux sur le site
des soins — Architecture d'échange orientée services entre dispositifs
médicaux et liaison par protocole
Reference number
ISO/IEEE 11073-20701:2020(E)
©
IEEE 2019
---------------------- Page: 7 ----------------------
SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
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
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
ISO/IEEE 11073-20701 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering
in Medicine and Biology Society (as IEEE Std 11073-20701-2018) 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.
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 11073-20701:2020
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SIST EN ISO 11073-20701:2020
Health informatics—Point-of-care medical device communication
Part 20701: Service-Oriented Medical
Device Exchange Architecture and
Protocol Binding
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 27 September 2018
IEEE-SA Standards Board
---------------------- Page: 11 ----------------------
SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC)
medical device communication, an architecture for service-oriented distributed PoC medical
devices and medical IT systems is defined. This standard defines a binding of the Participant,
Discovery, and Communication Model defined in IEEE Std 11073-10207™ to the profile for
transport over Web Services defined in IEEE Std 11073-20702™. Moreover, a binding to Network
Time Protocol (NTP) and Differentiated Services (DiffServ) is defined for time synchronization
and transport Quality of Service requirements.
Keywords: alert systems, BICEPS, DiffServ, IEEE 11073-20701™, ISO/IEEE 11073, MDPWS,
medical device communication, NTP, patient, point-of-care, remote control, service-oriented
architecture
The Institute of Electrical and Electronics Engineers, Inc.
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Copyright © 2019 by The Institute of Electrical and Electronics Engineers, Inc.
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PDF: ISBN 978-1-5044-5264-9 STD23381
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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.
2
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE documents are made available for use subject to important notices and legal disclaimers. These
notices and disclaimers, or a reference to this page, appear in all standards and may be found under the
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Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are
developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards
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consensus development process, approved by the American National Standards Institute (“ANSI”), which
brings together volunteers representing varied viewpoints and interests to achieve the final product. IEEE
Standards are documents developed through scientific, academic, and industry-based technical working
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IEEE Standards do not guarantee or ensure safety, security, health, or environmental protection, or ensure
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REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
3
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
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documents.
4
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Photocopies
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Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
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their own responsibility. Further information may be obtained from the IEEE Standards Association.
5
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Participants
At the time this IEEE standard was completed, the Point of Care Devices Working Group had the following
membership:
Jan Wittenber, Chair
Stefan Schlichting, Subgroup Chair
Bjoern Anderson Frank Golatowski Stephan Poehlsen
Malcolm Clarke David Gregorczyk Tracy Rausch
Todd Cooper Kai Hassing John Rhoads
Chris Courville John Hatcliff Paul Schluter
Michael Faughn Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Joerg-Uwe Meyer
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen Werner Hoelzl Stefan Schlichting
Lyle Bullock Noriyuki Ikeuchi Janek Schumann
Carole Carey Atsushi Ito Sarah Shafqat
Keith Chow Raj Jain Walter Struppler
Sourav Dutta Stefan Karl J. Wiley
Kenneth Fuchs Piotr Karocki Jan Wittenber
David Fuschi Martin Kasparick Oren Yuen
David Gregorczyk Thomas Kurihara Janusz Zalewski
Randall Groves Joerg-Uwe Meyer Daidi Zhong
Beth Pumo
When the IEEE-SA Standards Board approved this standard on 27 September 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
6
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Introduction
This introduction is not part of IEEE Std 11073-20701-2018, Health Informatics—Point-of-care medical device
communication—Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding.
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 medical devices
Facilitate the efficient exchange of vital signs and medical device 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 all the clinician has to do is to make the
connection—the Participants automatically detect, configure, and communicate without 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 received, parsed, and interpreted by many different types of applications
without unnecessary loss of information. The standards are especially targeted at acute, surgical, and
continuing care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, endoscopic
camera system, insufflators, endoscopic light sources, dissectors, etc. They comprise a family of standards
that can be bound to one another to provide optimized connectivity for devices at the Point-of-Care.
Within the context of the ISO/IEEE 11073 family of standards for PoC medical device communication, this
standard defines an architecture for service-oriented distributed PoC medical devices and medical IT
systems. It defines a binding of the Participant, Discovery, and Communication Model defined in
IEEE Std 11073-10207 to the profile for transport over Web Services defined in IEEE Std 11073-20702.
Moreover, a binding to Network Time Protocol (NTP) and Differentiated Services (DiffServ) is defined to
satisfy time synchronization and transport Quality of Service requirements.
7
Copyright © 2019 IEEE. All rights reserved.
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SIST EN ISO 11073-20701:2020
ISO/IEEE 11073-20701:2020(E)
Contents
1. Overview . 10
1.1 Scope . 10
1.2 Purpose . 10
2. Normative references . 10
3. Definitions . 11
4. Notational conventions . 15
4.1 XML schema namespaces . 15
5. Introduction . 16
6. Service-oriented medical device exchange architecture . 17
7. Service-oriented device connectivity (SDC) participant model binding . 18
7.1 Coded val
...
SLOVENSKI STANDARD
oSIST prEN ISO 11073-20701:2019
01-november-2019
Zdravstvena informatika - Medobratovalnost naprav - 20701. del: Komunikacija
medicinskih naprav na mestu oskrbe - Storitveno usmerjena arhitektura in
protokol za komunikacijo z medicinskimi napravami (ISO/IEEE FDIS 11073-
20701:2019)
Health informatics - Device interoperability - Part 20701: Point-of-care medical device
communication - Service oriented medical device exchange architecture and protocol
binding (ISO/IEEE FDIS 11073-20701:2019)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
20701: Service-Orientierte Architektur und Protokoll für Medizingeräte-Kommunikation
(ISO/IEEE FDIS 11073-20701)
Ta slovenski standard je istoveten z: prEN ISO 11073-20701
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 11073-20701:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 11073-20701:2019
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oSIST prEN ISO 11073-20701:2019
FINAL
INTERNATIONAL ISO/IEEE/ FDIS
DRAFT
STANDARD 11073-20701
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2019-08-30
Part 20701:
Voting terminates on:
Point-of-care medical device
2020-01-17
communication — Service oriented
medical device exchange architecture
and protocol binding
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/IEEE FDIS 11073-20701:2019(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. IEEE 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2019 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
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
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
ISO/IEEE 11073-20701 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering
in Medicine and Biology Society (as IEEE Std 11073-20701-2018) 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.
A list of all parts in the ISO 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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oSIST prEN ISO 11073-20701:2019
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oSIST prEN ISO 11073-20701:2019
Health informatics—Point-of-care medical device communication
Part 20701: Service-Oriented Medical
Device Exchange Architecture and
Protocol Binding
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 27 September 2018
IEEE-SA Standards Board
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oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC)
medical device communication, an architecture for service-oriented distributed PoC medical
devices and medical IT systems is defined. This standard defines a binding of the Participant,
Discovery, and Communication Model defined in IEEE Std 11073-10207™ to the profile for
transport over Web Services defined in IEEE Std 11073-20702™. Moreover, a binding to Network
Time Protocol (NTP) and Differentiated Services (DiffServ) is defined for time synchronization
and transport Quality of Service requirements.
Keywords: alert systems, BICEPS, DiffServ, IEEE 11073-20701™, ISO/IEEE 11073, MDPWS,
medical device communication, NTP, patient, point-of-care, remote control, service-oriented
architecture
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host institutions MIT, ERCIM, Keio, and Beihang.
PDF: ISBN 978-1-5044-5264-9 STD23381
Print: ISBN 978-1-5044-5265-6
STDPD23381
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permission of the publisher.
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oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
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oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
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oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
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oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
Participants
At the time this IEEE standard was completed, the Point of Care Devices Working Group had the following
membership:
Jan Wittenber, Chair
Stefan Schlichting, Subgroup Chair
Bjoern Anderson Frank Golatowski Stephan Poehlsen
Malcolm Clarke David Gregorczyk Tracy Rausch
Todd Cooper Kai Hassing John Rhoads
Chris Courville John Hatcliff Paul Schluter
Michael Faughn Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Joerg-Uwe Meyer
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen Werner Hoelzl Stefan Schlichting
Lyle Bullock Noriyuki Ikeuchi Janek Schumann
Carole Carey Atsushi Ito Sarah Shafqat
Keith Chow Raj Jain Walter Struppler
Sourav Dutta Stefan Karl J. Wiley
Kenneth Fuchs Piotr Karocki Jan Wittenber
David Fuschi Martin Kasparick Oren Yuen
David Gregorczyk Thomas Kurihara Janusz Zalewski
Randall Groves Joerg-Uwe Meyer Daidi Zhong
Beth Pumo
When the IEEE-SA Standards Board approved this standard on 27 September 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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oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
Introduction
This introduction is not part of IEEE Std 11073-20701-2018, Health Informatics—Point-of-care medical device
communication—Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding.
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 medical devices
Facilitate the efficient exchange of vital signs and medical device 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 all the clinician has to do is to make the
connection—the Participants automatically detect, configure, and communicate without 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 received, parsed, and interpreted by many different types of applications
without unnecessary loss of information. The standards are especially targeted at acute, surgical, and
continuing care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, endoscopic
camera system, insufflators, endoscopic light sources, dissectors, etc. They comprise a family of standards
that can be bound to one another to provide optimized connectivity for devices at the Point-of-Care.
Within the context of the ISO/IEEE 11073 family of standards for PoC medical device communication, this
standard defines an architecture for service-oriented distributed PoC medical devices and medical IT
systems. It defines a binding of the Participant, Discovery, and Communication Model defined in
IEEE Std 11073-10207 to the profile for transport over Web Services defined in IEEE Std 11073-20702.
Moreover, a binding to Network Time Protocol (NTP) and Differentiated Services (DiffServ) is defined to
satisfy time synchronization and transport Quality of Service requirements.
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oSIST prEN ISO 11073-20701:2019
ISO/IEEE FDIS 11073-20701:2019(E)
Contents
1. Overview . 10
1.1 Scope . 10
1.2 Purpose . 10
2. Normative references . 10
3. Definitions . 11
4. Notational conventions . 15
4.1 XML schema namespaces . 15
5. Introduction . 16
6. Service-oriented medical device exchange architecture . 17
7. Service-oriented device connectivity (SDC) participant model binding . 18
7.1 Coded values . 18
7.2 Remote-control capabilities . 18
7.3 Retrievability of containment tree entries . 20
7.4 Dynamic containment tree changes . 21
7.5 MDIB versioning . 22
7.6 Types . 22
8. Communication model binding . 23
8.1 Service . 23
8.2 Message . 25
9. Discovery binding . 27
9.1 Discovery mechanism . 27
9.2 Complex device component based discovery . 27
9.3 SDC PARTICIPANT KEY PURPOSE based discovery . 28
9.4 Context-based discovery . 29
9.5 Announcing absence . 31
10. Non-functional quality attributes . 31
10.1 Cybersecurity . 31
10.2 Patient safety. 33
10.3 Clinical effectiveness . 34
11. Conformance . 36
11.1 General format . 36
11.2 ICS tables . 37
Annex A (normative) Constants . 39
Annex B (normative) SDC service provider WSDL service descriptions . 40
B.1 Get Service .
...
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