oSIST prEN ISO/IEEE 11073-10103:2025

SLOVENSKI STANDARD
01-junij-2025
Zdravstvena informatika - Interoperabilnost naprav - 10103. del: Nomenklatura -
Pripomoček za vsaditev, srčni (ISO/IEEE FDIS 11073-10103:2025)
Health informatics - Device interoperability - Part 10103: Nomenclature - Implantable
device, cardiac (ISO/IEEE FDIS 11073-10103:2025)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
10103: Nomenklatur - Implantierbare kardiologische Geräte (ISO/IEEE FDIS 11073-
10103:2025)
Informatique de santé - Interopérabilité des dispositifs - Partie 10103: Nomenclature -
Dispositif implantable, cardiaque (ISO/IEEE FDIS 11073-10103:2025)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10103
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
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
11073-10103
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2025-04-07
Part 10103:
Nomenclature — Implantable
Voting terminates on:
2025-08-25
device, cardiac
Informatique de santé — Interopérabilité des dispositifs —
Partie 10103: Nomenclature — Dispositif implantable, cardiaque
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 11073­10103:2025(en) © IEEE 2025

FINAL DRAFT
ISO/IEEE FDIS 11073-10103:2025(en)
International
Standard
ISO/IEEE
FDIS
11073-10103
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10103:
Nomenclature — Implantable
Voting terminates on:
device, cardiac
Informatique de santé — Interopérabilité des dispositifs —
Partie 10103: Nomenclature — Dispositif implantable, cardiaque
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 SUPPORTING D OCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
© IEEE 2025
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 STAND ARDS 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 11073­10103:2025(en)
© IEEE 2024
© IEEE 2025 – All rights reserved
ii
ISO/IEEE 11073-10103:2025(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 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.
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 11073-10103 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073‐10103‐2023) and drafted in accordance with its editorial
rules. It was adopted, under the “fast-track procedure” defined in the Partner Standards Development
Organization cooperation agreement between ISO and IEEE, by Technical Committee ISO/TC 215, Health
informatics.
This second edition cancels and replaces the first edition (ISO/IEEE 11073-10103:2014), which has been
technically revised.
A list of all parts in the ISO/IEEE 11073 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iii
IEEE Std 11073-10103™-2023
(Revision of IEEE Std 11073-10103-2012)
Health Informatics—Device Interoperability

Part 10103: Point-of-Care
Medical Device Communication—
Nomenclature—Implantable Device,
Cardiac
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 8 November 2023
IEEE SA Standards Board
ISO/IEEE 11073-10103:2025(en)
Abstract: The base nomenclature provided in IEEE 11073 to support terminology for implantable
cardiac devices is extended in this standard. Devices within the scope of this nomenclature are
implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization
therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically
relevant summary of the information obtained during a device interrogation are defined in this
nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices
require the management of summary interrogation information from all vendor devices and
systems in a central system such as an Electronic Health Records (EHR) system or a device
clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC)
Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates
the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic
management system.
Keywords: cardiac resynchronization therapy, codes, CRT, follow-up, home monitoring, ICD,
IDC, IEEE 11073-10103™, implantable cardioverter defibrillator, implantable devices, implantable
device cardiac, medical device communication, nomenclature, pacemaker, remote follow-up,
remote monitoring, terminology
•
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
All rights reserved. Published 30 May 2024. 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 979-8-8557-0756-4 STD26947
Print: ISBN 979-8-8557-0757-1 STDPD26947
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.
ISO/IEEE 11073-10103:2025(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.html),
appear in all IEEE 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 involved in technical working groups
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 all standards, 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 compliance with law, 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.
ISO/IEEE 11073-10103:2025(en)
Translations
The IEEE consensus balloting process involves the review of documents in English only. In the event t
...