EN ISO/IEEE 11073-10701:2025
(Main)Health informatics - Device interoperability - Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system (ISO/IEEE 11073-10701:2024)
Health informatics - Device interoperability - Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system (ISO/IEEE 11073-10701:2024)
This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange 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 10701: Kommunikation von Geräten für die persönliche Gesundheit - Bereitstellung von Metriken durch Teilnehmer in einem serviceorientierten Gerätekonnektivitätssystem (SDC) (ISO/IEEE 11073-10701:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10701: Communication entre dispositifs médicaux sur le site de soins - Fourniture de métriques par les participants à un système de connectivité des dispositifs orientée services (SDC) (ISO/IEEE 11073-10701:2024)
La présente norme spécifie un ensemble d’objectifs clés des participants (PKP) relatifs à l’échange de données de métriques pour la série de normes sur la connectivité des dispositifs orientée services (SDC). Les PKP sont des ensembles d’exigences applicables aux produits établis sur la base des rôles visant à soutenir une interopérabilité sûre, efficace et sécurisée dans les réseaux de TI médicaux dans les environnements de sites de soins tels que l’unité de soins intensifs (USI), le bloc opératoire (BO) ou d’autres centres de soins intensifs. La présente norme spécifie à la fois le processus de développement du produit et les exigences techniques.
Zdravstvena informatika - Interoperabilnost naprav - 10701. del: Komunikacija medicinskih naprav na mestu oskrbe - Zagotavljanje metrike s strani udeležencev v storitvi - Sistem usmerjenega povezovanja naprav (SDC) (ISO/IEEE FDIS 11073-10701:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Zdravstvena informatika - Interoperabilnost naprav - 10701. del: Komunikacija
medicinskih naprav na mestu oskrbe - Zagotavljanje metrike s strani udeležencev
v storitvi - Sistem usmerjenega povezovanja naprav (SDC) (ISO/IEEE FDIS 11073-
10701:2024)
Health informatics - Device interoperability - Part 10701: Point-of-Care Medical Device
Communication - Metric Provisioning by Participants in a Service-Oriented Device
Connectivity (SDC) System (ISO/IEEE FDIS 11073-10701:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10701: Kommunikation von
Geräten für die persönliche Gesundheit - Bereitstellung von Metriken durch Teilnehmer
in einem serviceorientierten Gerätekonnektivitätssystem (SDC) (ISO/IEEE FDIS 11073-
10701:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10701: Titre manque
(ISO/IEEE FDIS 11073-10701:2024)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10701
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.
FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10701
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2024-04-11
Part 10701:
Point-of-Care Medical Device
Voting terminates on:
2024-08-29
Communication – Metric
Provisioning by Participants
in a Service-Oriented Device
Connectivity (SDC) System
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING 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.
Reference number
ISO/IEEE FDIS 1107310701:2024(en) © IEEE 2024
FINAL DRAFT
ISO/IEEE FDIS 11073-10701:2024(en)
International
Standard
ISO/IEEE
FDIS
11073-10701
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10701:
Point-of-Care Medical Device
Voting terminates on:
Communication – Metric
Provisioning by Participants
in a Service-Oriented Device
Connectivity (SDC) System
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
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
© IEEE 2024
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/IEEE FDIS 1107310701:2024(en) © IEEE 2024
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10701:2024(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.
ISO/IEEE 11073-10701 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10701) 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 2024 – All rights reserved
iii
ISO/IEEE 11073-10701:2024(en)
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 defines requirements for SDC metric participants in
an SDC system that comprises an IT network of medical devices to enable safe and secure contribution to system
functions based on the exchange of metric information.
Keywords: base PKP; BICEPS; communication protocol specification; device component; documentation and
process responsibilities; dynamic medical device interoperability; IEEE 11073-10701™; integrated clinical
environment; medical device communication; metric; metric PKP; participant key purpose; point-of-care service-
oriented device connectivity; risk management; safety, effectiveness, and security; SDC; 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 22 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 978-1-5044-9795-4 STD26225
Print: ISBN 978-1-5044-9796-1 STDPD26225
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 11073-10701:2024(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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.