SIST EN ISO 11073-10700:2025
(Main)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)
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)
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.
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)
La présente norme spécifie l’ensemble de base des objectifs clés des participants pour la série de normes relatives à la connectivité des dispositifs orientés services (SDC). Les objectifs clés des participants sont des ensembles d’exigences basés sur les rôles pour les produits afin de favoriser une interopérabilité sûre, efficace et sécurisée dans les réseaux TI médicaux sur les sites des soins tels que l’unité de soins intensifs (USI), la salle d’opération (OR) ou d’autres environnements de soins aigus. La présente norme spécifie à la fois le processus de développement du produit et les exigences techniques.
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)
General Information
Standards Content (Sample)
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 ju
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.