SIST EN ISO 11073-10700:2025

SLOVENSKI STANDARD
01-december-2025
Zdravstvena informatika - Interoperabilnost naprav - 10700. del: Komunikacija
medicinskih naprav na mestu oskrbe - Standard za osnovne zahteve za
udeležence v storitveno usmerjenem sistemu povezovanja naprav (SDC) (ISO/IEEE
11073-10700:2024)
Health informatics - Device interoperability - Part 10700: Point-of-care medical device
communication - Standard for base requirements for participants in a Service‐oriented
Device Connectivity (SDC) system (ISO/IEEE 11073-10700:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10700: Kommunikation
persönlicher Gesundheitsgeräte - Standard für Basisanforderungen für Teilnehmer an
einem serviceorientierten Gerätekonnektivitätssystem (SDC) (ISO/IEEE 11073-
10700:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10700: Communication
entre dispositifs médicaux sur le site des soins - Norme relative aux exigences de base
pour les participants à un système de connectivité de dispositifs orientée services (SDC)
(ISO/IEEE 11073-10700:2024)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10700:2025
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO/IEEE 11073-
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2025
ICS 35.240.80
English Version
Health informatics - Device interoperability - Part 10700:
Point-of-care medical device communication - Standard for
base requirements for participants in a Service-oriented
Device Connectivity (SDC) system (ISO/IEEE 11073-
10700:2024)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Interoperabilität von
- Partie 10700: Communication entre dispositifs Geräten - Teil 10700: Kommunikation persönlicher
médicaux sur le site des soins - Norme relative aux Gesundheitsgeräte - Standard für Basisanforderungen
exigences de base pour les participants à un système für Teilnehmer an einem serviceorientierten
de connectivité de dispositifs orientée services (SDC) Gerätekonnektivitätssystem (SDC) (ISO/IEEE 11073-
(ISO/IEEE 11073-10700:2024) 10700:2024)
This European Standard was approved by CEN on 30 September 2024.

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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10700:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO/IEEE 11073-10700:2025) 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 April 2026, and conflicting national standards shall be
withdrawn at the latest by April 2026.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10700:2024 has been approved by CEN as EN ISO/IEEE 11073-
10700:2025 without any modification.

International
Standard
ISO/IEEE
11073-10700
First edition
Health informatics — Device
2024-09
interoperability —
Part 10700:
Point‐of‐care medical device
communication — Standard for
base requirements for participants
in a Service‐oriented Device
Connectivity (SDC) system
Informatique de santé — Interopérabilité des dispositifs —
Partie 10700: Communication entre dispositifs médicaux sur le
site des soins — Norme relative aux exigences de base pour les
participants à un système de connectivité de dispositifs orientée
services (SDC)
Reference number
ISO/IEEE 11073-10700:2024(en) © IEEE 2024

ISO/IEEE 11073‐10700:2024(en)
© IEEE 2024
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
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10700:2024(en)
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 document 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.
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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.
© IEEE 2024 – All rights reserved
iii
ISO/IEEE 11073-10700:2024(en)
ISO/IEEE 11073-10700 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10700) 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.Abstract: Medical devices that offer a
communication interface as specified by the IEEE 11073 Service-oriented Device Connectivity (SDC) standards can
be integrated into a health IT system to jointly execute system functions. However, implementing the IEEE 11073
SDC communication protocol is not sufficient to demonstrate safety, effectiveness, and security of system functions
resulting from the combination of system function contributions from two or more medical devices. SDC participant
key purposes (PKPs) are sets of requirements that allow for manufacturers to have certain expectations about
BICEPS participants from other manufacturers. This common understanding enables the manufacturers to perform
risk management, verification, validation, and usability engineering for the safe use of system functions. This
standard specifies requirements for the allocation of responsibilities to SDC base participants.

Keywords: base PKP; BICEPS; communication protocol specification; documentation and process responsibilities;
dynamic medical device interoperability; IEEE 11073-10700™; integrated clinical environment; participant key
purpose; point-of-care medical device communication; risk management; SDC; service-oriented device connectivity;
safety, effectiveness, and security; system function; system function contribution; usability engineering

•
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA

All rights reserved. Published 15 September 2023. Printed in the United States of America.

IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics
Engineers, Incorporated.
PDF: ISBN 978-1-5044-9848-7 STD26263
Print: ISBN 978-1-5044-9849-4 STDPD26263

IEEE prohibits discrimination, harassment, and bullying.
For more information, visit https://www.ieee.org/about/corporate/governance/p9-26.html.
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.
© IEEE 2024 – All rights reserved
iv
ISO/IEEE 11073-10700:2024(en)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE Standards documents are made available for use subject to important notices and legal disclaimers. These notices and
disclaimers, or a reference to this page (https://standards.ieee.org/ipr/disclaimers), appear in all standards and may be found
under the heading “Important Notices and Disclaimers Concerning IEEE Standards Documents.”
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents
IEEE Standards documents are developed within IEEE Societies and subcommittees of IEEE Standards Association (IEEE SA)
Board of Governors. IEEE develops its standards through an accredited consensus development process, which brings together
volunteers representing varied viewpoints and interests to achieve the final product. IEEE standards are documents developed by
volunteers with scientific, academic, and industry-based expertise in technical working groups. Volunteers are not necessarily
members of IEEE or IEEE SA and participate without compensation from IEEE. While IEEE administers the process and
establishes rules to promote fairness in the consensus development process, IEEE does not independently evaluate, test, or
verify the accuracy of any of the information or the soundness of any judgments contained in its standards.
IEEE makes no warranties or representations concerning its standards, and expressly disclaims all warranties, express or
implied, concerning this standard, including but not limited to the warranties of merchantability, fitness for a particular purpose
and non-infringement IEEE Standards documents do not guarantee safety, security, health, or environmental protection, or
guarantee against interference with or from other devices or networks. In addition, IEEE does not warrant or represent that the
use of the material contained in its standards is free from patent infringement. IEEE Standards documents are supplied “AS IS”
and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there are no other ways to
produce, test, measure, purchase, market, or provide other goods and services related to the scope of the IEEE standard.
Furthermore, the viewpoint expressed at the time a standard is approved and issued is subject to change brought about through
developments in the state of the art and comments received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other services for, or on
behalf of, any person or entity, nor is IEEE undertaking to perform any duty owed by any other person or entity to another. Any
person utilizing any IEEE Standards document, should rely upon their own independent judgment in the exercise of reasonable
care in any given circumstances or, as appropriate, seek the advice of a competent professional in determining the
appropriateness of a given IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR
CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO: THE NEED TO PROCURE SUBSTITUTE
GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED
AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING
NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND REGARDLESS OF
WHETHER SUCH DAMAGE WAS FORESEEABLE.
Translations
The IEEE consensus balloting process involves the review of documents in English only. In the event that an IEEE standard is
translated, only the English version published by IEEE is the approved IEEE standard.
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE SA Standards Board Operations Manual shall not
be considered or inferred to be the official position of IEEE or any of its committees and shall not be considered to be, nor be
relied upon as, a formal position of IEEE. At lectures, symposia, seminars, or educational courses, an individual presenting
information on IEEE standards shall make it clear that the presenter’s views should be considered the personal views of that
individual rather than the formal position of IEEE, IEEE SA, the Standards Committee, or the Working Group. Statements made
by volunteers may not represent the formal position of their employer(s) or affiliation(s).
© IEEE 2024 – All rights reserved
v
ISO/IEEE 11073-10700:2024(en)
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of membership
affiliation with IEEE or IEEE SA. However, IEEE does not provide interpretations, consulting information, or advice
pertaining to IEEE Standards documents.
Suggestions for changes in documents should be in the form of a proposed change of text, together with appropriate supporting
comments. Since IEEE standards represent a consensus of concerned interests, it is important that any responses to comments
and questions also receive the concurrence of a balance of interests. For this reason, IEEE and the members of its Societies and
subcommittees of the IEEE SA Board of Governors are not able to provide an instant response to comments, or questions except
in those cases where the matter has previously been addressed. For the same reason, IEEE does not respond to interpretation
requests. Any person who would like to participate in evaluating comments or in revisions to an IEEE standard is welcome to
join the relevant IEEE working group. You can indicate interest in a working group using the Interests tab in the Manage Profile
& Interests area of the IEEE SA myProject system. An IEEE Account is needed to access the application.
Comments on standards should be submitted using the Contact Us form.
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with the provisions of any
IEEE Standards document does not constitute compliance to any applicable regulatory requirements. Implementers of the
standard are responsible for observing or referring to the applicable regulatory requirements. IEEE does not, by the publication
of its standards, intend to urge action that is not in compliance with applicable laws, and these documents may not be construed
as doing so.
Data privacy
Users of IEEE Standards documents should evaluate the standards for considerations of data privacy and data ownership in the
context of assessing and using the standards in compliance with applicable laws and regulations.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws. They are made
available by IEEE and are adopted for a wide variety of both public and private uses. These include both use, by reference, in
laws and regulations, and use in private self-regulation, standardization, and the promotion of engineering practices and
methods. By making these documents available for use and adoption by public authorities and private users, neither IEEE nor its
licensors waive any rights in copyright to the documents.
Photocopies
Subject to payment of the appropriate licensing fees, IEEE will grant users a limited, non-exclusive license to photocopy
portions of any individual standard for company or organizational internal use or individual, non-commercial use only. To
arrange for payment of licensing fees, please contact Copyright Clearance Center, Customer Service, 222 Rosewood Drive,
Danvers, MA 01923 USA; +1 978 750 8400; https://www.copyright.com/. Permission to photocopy portions of any individual
standard for educational classroom use can also be obtained through the Copyright Clearance Center.
Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time by the issuance of
new editions or may be amended from time to time through the issuance of amendments, corrigenda, or errata. An official IEEE
document at any point in time consists of the current edition of the document together with any amendments, corrigenda, or
errata then in effect.
Every IEEE standard is subjected to review at least every 10 years. When a document is more than 10 years old and has not
undergone a revision process, it is reasonable to conclude that its contents, although still of some value, do not wholly reflect the
present state of the art. Users are cautioned to check to determine that they have the latest edition of any IEEE standard.

Available at: https://development.standards.ieee.org/myproject-web/public/view.html#landing.
Available at: https://standards.ieee.org/content/ieee-standards/en/about/contact/index.html.
© IEEE 2024 – All rights reserved
vi
ISO/IEEE 11073-10700:2024(en)
In order to determine whether a given document is the current edition and whether it has been amended through the issuance of
amendments, corrigenda, or errata, visit IEEE Xplore or contact IEEE. For more information about the IEEE SA or IEEE’s
standards development process, visit the IEEE SA Website.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE SA Website. Search for standard number and year of
approval to access the web page of the published standard. Errata links are located under the Additional Resources Details
section. Errata are also available in IEEE Xplore. Users are encouraged to periodically check for errata.
Patents
IEEE standards are developed in compliance with the IEEE SA Patent Policy.
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 by the IEEE with respect to the existence or validity of any patent
rights in connection therewith. If a patent holder or patent applicant has filed a statement of assurance via an Accepted Letter of
Assurance, then the statement is listed on the IEEE SA Website at https://standards.ieee.org/about/sasb/patcom/patents.html.
Letters of Assurance may indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of any unfair
discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not responsible for
identifying Essential Patent Claims for which a license may be required, for conducting inquiries into the legal validity or scope
of Patents Claims, or determining whether any licensing terms or conditions provided in connection with submission of a Letter
of Assurance, if any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely their own
responsibility. Further information may be obtained from the IEEE Standards Association.
IMPORTANT NOTICE
Technologies, application of technologies, and recommended procedures in various industries evolve over time. The IEEE
standards development process allows participants to review developments in industries, technologies, and practices, and to
determine what, if any, updates should be made to the IEEE standard. During this evolution, the technologies and
recommendations in IEEE standards may be implemented in ways not foreseen during the standard’s development. IEEE
standards development activities consider research and information presented to the standards development group in developing
any safety recommendations. Other information about safety practices, changes in technology or technology implementation, or
impact by peripheral systems also may be pertinent to safety considerations during implementation of the standard.
Implementers and users of IEEE Standards documents are responsible for determining and complying with all appropriate
safety, security, environmental, health, and interference protection practices and all applicable laws and regulations.

Available at: https://ieeexplore.ieee.org/browse/standards/collection/ieee.
Available at: https://standards.ieee.org/standard/index.html.
Available at: https://standards.ieee.org/about/sasb/patcom/materials.html.
© IEEE 2024 – All rights reserved
vii
ISO/IEEE 11073-10700:2024(en)
Participants
At the time this IEEE standard was completed, the Point-of-Care Devices Working Group had the following membership:
Stefan Schlichting, Chair
Martin Kasparick, Subgroup Chair
Björn Andersen Christian Haye Erik Moll
Fabian Baumeister Werner Hoelzl Karen Moniz
Jin-Woo Choi Martin Hurrell Jody Paul
Malcolm Clarke Andy Iverson Craig Reister
Paul Close Jennifer Jacobs John Rhoads
Todd Cooper Sven Kämmer Sean Rocke
Sandra Costanzo Anton Keller Martin Rosner
Steven Dain Tobias Klotz Enrico Rudorf
Kurt Elliason Satoshi Kobayashi Gilani Sadeghi
Javier Espina Anil Kochhar Paul Schluter
Michael Faughn Peter Kranich Elliot Silver
Ken Fuchs Ray Krasinski Tulasi Sivanesan
John Garguilo Jithin Krishnan Isabel Tejero
Frank Golatowski Sungkee Lee James Vollmer
David Gregoczyk Konstantinos Makrodimitris Brian Witkowski
Steve Griffiths Koichiro Matsumoto Ravi Sekhar Yarrabothu
Peter Gunter Jörg-Uwe Meyer Greg Zeller
Bob Harbort Madhu Mohan Daidi Zhong

The following members of the individual Standards Association balloting group voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen David Fuschi Javier Luiso
Pradeep Balachandran Frank Golatowski H. Moll
Fabian Baumeister David Gregorczyk Bansi Patel
Lyle Bullock Werner Hoelzl Dalibor Pokrajac
Pin Chang Piotr Karocki John Rhoads
Diego Chiozzi Martin Kasparick Elie Sarraf
Todd Cooper Stuart Kerry Stefan Schlichting
Houde Dai Edmund Kienast Walter Struppler
Kurt Elliason Yongbum Kim Maria Isabel Tejero del Rio
Michael Faughn Raymond Krasinski John Vergis
Immanuel Freedman Ting Li Yu Yuan
Kenneth Fuchs Oren Yuen
When the IEEE SA Standards Board approved this standard on 8 November 2022, it had the following membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Edward A. Addy Johnny Daozhuang Lin Mark Siira
Ramy Ahmed Fathy Kevin Lu Dorothy V. Stanley
J. Travis Griffith Daleep C. Mohla Lei Wang
Guido R. Hiertz Andrew Myles F. Keith Waters
Yousef Kimiagar Damir Novosel Karl Weber
Joseph L. Koepfinger* Annette D. Reilly Sha Wei
Thomas Koshy Robby Robson Philip B. Winston
John D. Kulick Jon Walter Rosdahl Daidi Zhong
*Member Emeritus
© IEEE 2024 – All rights reserved
viii
ISO/IEEE 11073-10700:2024(en)
Introduction
This introduction is not part of IEEE Std 11073-10700-2022, Health Informatics—Device Interoperability—Part 10700: Point-of-Care
Medical Device Communication—Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System.
The IEEE 11073 Point-of-Care Medical Device Communication Standards enable communication between health IT elements
in a HEALTH IT SYSTEM including MEDICAL DEVICEs. 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. “Real-time” means that data from multiple
MEDICAL DEVICEs can be retrieved, temporally correlated, displayed, and processed in fractions of a second. “Plug-
and-play” means that there are no recurring configuration steps necessary to enable data exchange between MEDICAL
DEVICEs.
⎯ Facilitate the efficient and effective exchange of vital signs and MEDICAL DEVICE data acquired at the PoC in all
health care environments. “Efficient and effective exchange of MEDICAL DEVICE data” means that data captured at
the PoC, e.g., patient vital signs, can be received, parsed, and interpreted by different types of applications without the
loss of safety-critical information.
The IEEE 11073 Point-of-Care Medical Device Communication Standards are targeted at surgical as well as acute and
continuous care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, endoscopic camera systems,
insufflators, dissectors, etc. They build a family of standards that can be bound to one another to provide optimized connectivity
for devices at the PoC.
Within the context of the ISO/IEEE 11073 family of standards for Point-of-Care Medical Device Communication, this standard
defines the requirements for SDC BASE PARTICIPANTs in an SDC SYSTEM that comprises an IT NETWORK of MEDICAL
DEVICEs to enable safe and secure contribution to SYSTEM FUNCTIONs.
Acknowledgments
The author thanks the International Electrotechnical Commission (IEC) for permission to reproduce Information from its
International Standards. All such extracts are copyright of IEC, Geneva, Switzerland. All rights reserved. Further information on
the IEC is available from www.iec.ch. IEC has no responsibility for the placement and context in which the extracts and
contents are reproduced by the author, nor is IEC in any way responsible for the other content or accuracy therein.
IEC 60601-1 ed.3.2 Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch
IEC 60601-1-8 ed.2.0 Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch
IEC 62366-1 ed.1.0 Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch
The following material is reproduced from the International Organization for Standardization (ISO) with permission of the
American National Standards Institute (ANSI) on behalf of ISO All rights reserved.
ISO 20417:2021, Sections 3.2 and 3.11
ISO 81001-1:2021, Sections 3.2, 3.14, 3.1.12, 3.3.8, and 3.3.11
ISO 14971:2019, Section 3.18
© IEEE 2024 – All rights reserved
ix
ISO/IEEE 11073-10700:2024(en)
Contents
1. Overview 1
1.1 Scope 1
1.2 Word usage 1
1.3 Service-oriented Device Connectivity standards 1
1.4 Participant key purposes 1
2. Normative references 2
3. Definitions, acronyms, and abbreviations 3
3.1 Definitions 3
3.2 Acronyms and abbreviations 8
4. Notational conventions 9
4.1 Requirement categories and numbering 9
4.2 References to IEEE 11073-10207 model elements 10
4.3 XML Schema namespaces 10
4.4 Notation of IEEE 11073 Nomenclature codes 10
5. Responsibilities 11
5.1 General responsibilities 11
5.2 Intended interoperability 13
5.3 System integration 16
5.4 System use 23
6. Technical design 24
6.1 SDC PARTICIPANT KEY PURPOSE conformity assurance 24
6.2 Standards conformity indication in the CONTAINMENT TREE 25
6.3 Cybersecurity 25
6.4 Logging 26
6.5 Maximum load conditions 27
6.6 Participant model 27
6.7 Extension model 34
6.8 Localization 34
6.9 Calibration 35
7. Conformity 35
7.1 Implementation conformity statements 36
Annex A (normative) Object identifiers 40
A.1 OID assignments 40
A.2 Participant Key Purpose concept definitions 40
Annex B (informative) Utilized IEEE 11073 Nomenclature 41
Annex C (informative) SDC PARTICIPANT ENSEMBLE inference 42
Annex D (informative) Bibliography 45
© IEEE 2024 – All rights reserved
x
ISO/IEEE 11073-10700:2024(en)
Health Informatics—Device Interoperability

Part 10700: Point-of-Care Medical Device Communication—
Standard for Base Requirements for Participants in a Service-
Oriented Device Connectivity (SDC) System
1. Overview
1.1 Scope
This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC)
series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure
interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room
(OR) or other acute care settings. This standard specifies both product development process and technical requirements.
1.2 Word usage
The word shall indicates mandatory requirements strictly to be followed in order to conform to the standard and from which no
,
6 7
deviation is permitted (shall equals is required to).
The word should indicates that among several possibilities one is recommended as particularly suitable, without mentioning or
excluding others; or that a certain course of action is preferred but not necessarily required (should equals is recommended that).
The word may is used to indicate a course of action permissible within the limits of the standard (may equals is permitted to).
The word can is used for statements of possibility and capability, whether material, physical, or causal (can equals is able to).
1.3 Service-oriented Device Connectivity standards
The SDC STANDARDs are a subset of the IEEE 11073 standards and define requirements for MEDICAL DEVICEs and other
participants that exchange physiological or technical information or enable external control while being operated in an IT
NETWORK.
The SDC STANDARDs comprise the specification of a domain and message model (IEEE Std 11073-10207) and transport
technology (IEEE Std 11073-20702) that form a service-oriented MEDICAL DEVICE architecture (IEEE Std 11073-20701).
These SDC core standards constitute the technical building blocks for foundational, structural, and semantic MEDICAL
DEVICE interoperability over secure data transmission. The SDC PKP STANDARDs (see 1.4) and particular SDC Device
Specializations address additional levels.
1.4 Participant key purposes
MEDICAL DEVICEs that offer a communication interface as specified by the SDC STANDARDs can be integrated into a
HEALTH IT SYSTEM on behalf of the SYSTEM OWNER, establishing an SDC SYSTEM to be used by the HEALTHCARE
DELIVERY ORGANIZATION.
The SYSTEM FUNCTIONs made available in an SDC SYSTEM depend on the individual SYSTEM FUNCTION
CONTRIBUTIONs of its BICEPS PARTICIPANTs. Accordingly, the MANUFACTURER of a BICEPS SERVICE

The use of the word must is deprecated and cannot be used when stating mandatory requirements; must is used only to describe unavoidable situations.
The use of will is deprecated and cannot be used when stating mandatory requirements; will is only used in statements of fact.
Information on references can be found in Clause 2.
© IEEE 2024 – All rights reserved
ISO/IEEE 11073-10700:2024(en)
PROVIDER can only specify its INTENDED SYSTEM FUNCTION CONTRIBUTIONs, whereas the MANUFACTURER of a
BICEPS SERVICE CONSUMER can specify the intended SYSTEM FUNCTIONs as well as the SYSTEM FUNCTION
CONTRIBUTIONs required from BICEPS SERVICE PROVIDERs in the SDC SYSTEM.
But to verify the safety, effectiveness, and security of these SYSTEM FUNCTIONs, only implementing the communication
protocol based on the SDC STANDARDs is not sufficient. The safety, effectiveness, and security of the SDC SYSTEM is based
on allocating responsibilities to the individual BICEPS PARTICIPANTs according to the requirements of the SDC
PARTICIPANT KEY PURPOSEs (PKPs) they assume.
The responsibility for the individual products as BICEPS PARTICIPANTs in an SDC SYSTEM remains with the
MANUFACTURERs whereas the SYSTEM OWNER is responsible for integration of the products into a HEALTH IT
SYSTEM and the ADMINISTRATOR is responsible for operation and maintenance of the HEALTH IT SYSTEM (see ISO
81001-1:2021, Clause 4.5 [B16]). In addition, the SYSTEM OWNER and ADMINISTRATOR take the responsibilities placed
on them by declarations in the ACCOMPANYING INFORMATION of the individual products that are to be integrated, e.g.,
pertaining to configuration, NETWORK BANDWIDTH, etc.
The SDC PKP STANDARDs specify the allocation of responsibilities and allow for MANUFACTURERs to have certain
expectations about BICEPS PARTICIPANTs from other MANUFACTURERs. Conformity to SDC PKP STANDARDs and
indication of this conformity creates confidence in these expectations and enables MANUFACTURERs to take the
responsibilities for SYSTEM FUNCTION CONTRIBUTIONs of their BICEPS PARTICIPANTs in an SDC SYSTEM. These
responsibilities pertain to technical design, implementation, verification, validation, RISK MANAGEMENT, USABILITY
ENGINEERING, and labeling of BICEPS PARTICIPANTs.
This standard defines the SDC BASE PROVIDER and the SDC BASE CONSUMER PKPs. They comprise the base
requirements for MANUFACTURERs to support safe, effective, and secure operation of their SDC BASE PARTICIPANTs in
an SDC SYSTEM.
MANUFACTURERs of SDC BASE PROVIDERs can assess and specify which requirements need to be fulfilled by SDC
BASE CONSUMERs for the safe use of SYSTEM FUNCTION CONTRIBUTIONs. Based on conformity of SDC BASE
CONSUMERs to this and other SDC PKP STANDARDs, SDC BASE PROVIDERs can restrict access to BICEPS SERVICEs
in the HEALTH IT SYSTEM.
For exchanging metric data, ALERT information, and external control commands, conformity with further SDC PKP
STANDARDs is recommended. Requirements that relate to specific SYSTEM FUNCTIONs or SYSTEM FUNCTION
CONTRIBUTIONs can be specified in additional SDC PARTICIPANT KEY PURPOSEs.
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must be understood and
used, so each referenced document is cited in text and its relationship to this document is explained). For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments or
corrigenda) applies.
,
10 11
IEEE Std 11073-10101™, Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature.
IEEE Std 11073-10207™, Health informatics—Point-of-care medical device communication—Part 10207: Domain Information
and Service Model for Service-Oriented Point-of-Care Medical Device Communication.
IEEE Std 11073-20701™, Health informatics—Point-of-care medical device communication—Part 20701: Service-Oriented
Medical Device Exchange Architecture and Protocol Binding.

The numbers in brackets correspond to those of the bibliography in Annex D.
The IEEE standards or products referred to in this annex are trademarks owned by The Institute of Electrical and Electronics Engineers, Incorporated.
IEEE publications are available from The Institute of Electrical and Electronics Engineers (https://standards.ieee.org/).
© IEEE 2024 – All rights reserved
ISO/IEEE 11073-10700:2024(en)
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this document, the following terms and definitions apply. The IEEE Standards Dictionary Online should be
consulted for terms not defined in this clause.
ACCOMPANYING INFORMATION: Information accompanying or marked on a MEDICAL DEVICE or accessory for the
USER or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the MEDICAL
DEVICE or accessory, particularly regarding safe use. (adapted from ISO 20417:2021 [B14])
NOTE 1—The ACCOMPANYING INFORMATION is regarded as part of the MEDICAL DEVICE or accessory.
NOTE 2—The ACCOMPANYING INFORMATION can consist of the label, marking, INSTRUCTIONS FOR USE, technical description,
installation manual, quick reference guide, etc.
NOTE 3—ACCOMPANYING INFORMATION is not necessarily a written or printed document but could involve auditory, visual, or tactile
materials and multiple media types (e.g., compact disc/digital video disc, USB stick, website).
NOTE 4—Definition has been modified by deleting Note 4 through Note 7.
ADMINISTRATOR: Legal person responsible for the ongoing operation of the implemented HEALTH IT SYSTEM and
ensuring it is safeguarded and maintained on an ongoing basis. (adapted from ISO 81001-1:2021 [B16])
NOTE—Definition has been modified by replacing “person with role” with “legal person.”
ALERT: Generic term for physiological alarm conditions, technical alarm conditions, and conditions resulting in advisory
signals. (adapted from IEC 60601-1-8:2006/AMD 2:2020 [B3])
NOTE—Definition has been modified by replacing “synonym for the combination of” with “generic term for” and “advisories” with
“conditions resulting in advisory signals.”
BICEPS CONTAINMENT SUBTREE: A BICEPS CONTAINMENT TREE ENTRY and all child elements of that BICEPS
CONTAINMENT TREE ENTRY, transitively including children of children etc. A BICEPS CONTAINMENT SUBTREE also
includes all elements of any XML Schema type that extends pm:AbstractState that use @DescriptorHandle to refer to a node
within the BICEPS CONTAINMENT SUBTREE as well as the element content, attributes, and child elements of these
elements.
NOTE—This includes child elements of any XML Schema type that extends pm:AbstractDescriptor.
BICEPS CONTAINMENT TREE: Capability description and configuration state of a MEDICAL DEVICE SYSTEM. It
constitutes a rooted tree of BICEPS CONTAINMENT TREE ENTRIEs, the hierarchy of which is specified in IEEE Std 11073-
10207-2017, 5.3 [B10]. Its root node is a BICEPS CONTAINMENT TREE ENTRY of the XML Schema type
pm:MdsDescriptor.
NOTE—There can be zero, one, or multiple BICEPS CONTAINMENT TREEs within a BICEPS SERVICE PROVIDER’s MDIB.
BICEPS CONTAINMENT TREE ENTRY: Single element of any XML Schema type that extends pm:AbstractDescriptor. It
includes its element content, attributes, and those child elements that are not of any XML Schema type that extends
pm:AbstractDescriptor. A BICEPS CONTAINMENT TREE ENTRY also includes all elements of any XML Schema type that
extends pm:AbstractState that use @DescriptorHandle to refer to the node as well as all the element content, attributes, and
child elements of these elements.
BICEPS PARTICIPANT: A network node that is part of a SOMDS and exchanges information by providing BICEPS
SERVICEs, consuming BICEPS SERVICEs, or both.

IEEE Standards Dictionary Online is available at: http://dictionary.ieee.org. An IEE
...