SIST EN ISO/IEEE 11073-10103:2025
(Main)Health informatics - Device interoperability - Part 10103: Nomenclature, implantable device, cardiac (ISO/IEEE 11073-10103:2025)
Health informatics - Device interoperability - Part 10103: Nomenclature, implantable device, cardiac (ISO/IEEE 11073-10103:2025)
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil 10103: Nomenklatur - Implantierbare kardiologische Geräte (ISO/IEEE 11073-10103:2025)
Informatique de santé - Interopérabilité des dispositifs - Partie 10103: Nomenclature, dispositif implantable, cardiaque (ISO/IEEE 11073-10103:2025)
Le présent document étend la nomenclature de base fournie dans l'ISO/IEEE 11073-10101:2020 pour prendre en charge la terminologie des dispositifs cardiaques implantables. Les dispositifs entrant dans le champ d'application de cette nomenclature sont les dispositifs implantables tels que les stimulateurs cardiaques, les défibrillateurs, les dispositifs de thérapie de resynchronisation cardiaque et les moniteurs cardiaques implantables. Cette nomenclature définit les termes nécessaires pour transmettre un résumé cliniquement pertinent des informations obtenues lors de l'interrogation d'un dispositif. Les extensions de la nomenclature peuvent être utilisées conjointement avec d'autres composants de la norme IEEE 11073 (par exemple, ISO/IEEE 11073-10201 [B2] ) ou avec d'autres normes, telles que Health Level Seven International (HL7).
Zdravstvena informatika - Interoperabilnost naprav - 10103. del: Nomenklatura, pripomoček za vsaditev, srčni (ISO/IEEE 11073-10103:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST EN ISO 11073-10103:2014
Zdravstvena informatika - Interoperabilnost naprav - 10103. del: Nomenklatura,
pripomoček za vsaditev, srčni (ISO/IEEE 11073-10103:2025)
Health informatics - Device interoperability - Part 10103: Nomenclature, implantable
device, cardiac (ISO/IEEE 11073-10103:2025)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
10103: Nomenklatur - Implantierbare kardiologische Geräte (ISO/IEEE 11073-
10103:2025)
Informatique de santé - Interopérabilité des dispositifs - Partie 10103: Nomenclature,
dispositif implantable, cardiaque (ISO/IEEE 11073-10103:2025)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10103:2025
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.
EN ISO/IEEE 11073-
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2025
ICS 11.040.40; 35.240.80 Supersedes EN ISO 11073-10103:2013
English Version
Health informatics - Device interoperability - Part 10103:
Nomenclature, implantable device, cardiac (ISO/IEEE
11073-10103:2025)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Kommunikation
- Partie 10103: Nomenclature, dispositif implantable, patientennaher medizinischer Geräte - Teil 10103:
cardiaque (ISO/IEEE 11073-10103:2025) Nomenklatur - Implantierbare kardiologische Geräte
(ISO/IEEE 11073-10103:2025)
This European Standard was approved by CEN on 26 September 2025.
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 11073-10103:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO/IEEE 11073-10103:2025) 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.
This document supersedes EN ISO 11073-10103:2013.
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 11073-10103 has been approved by CEN as EN ISO/IEEE 11073-10103:2025
without any modification.
International
Standard
ISO/IEEE
11073-10103
Second edition
Health informatics — Device
interoperability —
2025-10
Part 10103:
Nomenclature, implantable
device, cardiac
Informatique de santé — Interopérabilité des dispositifs —
Partie 10103: Nomenclature, dispositif implantable, cardiaque
Reference number
ISO/IEEE 11073-10103:2025(en)
© IEEE 2024
ISO/IEEE 11073-10103:2025(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 11073-10103:2025(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.
The main changes are as follows:
— new nomenclature (including discriminators, co-constraints, and enumeration as appropriate):
— device advisory information and UDI;
— lead advisory information and UDI;
— battery remaining timeframes and date of RRT;
— CRT multisite pacing status and LVLV delay;
— LV multisite pacing settings;
© IEEE 2024 – All rights reserved
iii
ISO/IEEE 11073-10103:2025(en)
— blanking and refractory settings;
— AF suppression and RV pace avoidance algorithm setting information;
— statistics for ventricular rates during atrial tachyarrhythmias and mode switch mode;
— multiple tachycardia therapy statistics (e.g. shocks, ATPs, recent, total);
— multiple episode-related information (e.g. shocks delivered, ATPs delivered,
atrial/ventricular intervals);
— episode in progress flagNotifications (new containment node);
— nomenclature versioning (new containment node);
— vendor-specific enumerations;
— clarified definitions of reference IDs;
— added nomenclature version information and example values to the base terms table;
— added implementation notes Annex G;
— removed schema and XML terms annexes that were used to help publish the original nomenclature
but were not part of the nomenclature;
— updated the units of measure and ensured all units have UCUM and MDC reference and term codes;
— updated example report Annex F;
— added multiple implementation notes in Annex G.
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 2024 – All rights reserved
iv
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.
--
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.