SIST EN ISO/IEEE 11073-10103:2025

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)
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Published in Switzerland
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10103:2025(en)
Foreword
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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
•
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ISO/IEEE 11073-10103:2025(en)
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ISO/IEEE 11073-10103:2025(en)
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ISO/IEEE 11073-10103:2025(en)
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ISO/IEEE 11073-10103:2025(en)
Participants
At the time this standard was completed, the Point-of-Care Working Group had the following membership:
Stefan Schlichting, Chair
Craig Reister, Subgroup Chair
Björn Andersen Martin Hurrell Roland Persson
Piyush Bhageriya Anders Häggström Mikael Petrini
Manfred Bier Per Johansson Jan-Alrik Philipsen
Kimberly Brauer Norman Jones Dalibor Pokrajac
Malcolm Clarke Martin Kasparick John Rhoads
Todd Cooper Tobias Klotz Jeff Rinda
Steven Dain Tom Kowalczyk Mathieu Roullet
Lisa Diggett Mike Krajnak Daniel Rubery
Kurt Elliason Thomas Kreuger Neil Seidl
Al Engelbert Konstantinos Makrodimitris Naveen Sharma
Javier Espina Duane Martz Michael Tietz
Michael Faughn Eldon Metz Peter Verständig
Kenneth Fuchs Steve Myers John Walsh
John Garguilo Teri Neal Rob Wilder
David Gregorczyk Steven Nichols Brian Witkowski
Bill Haralson Monroe Pattillo Daidi Zhong

The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Pradeep Balachandran Charles Gropper Paul Schluter
Bill Brown Werner Hoelzl Harry Solomon
Pin Chang Piotr Karocki Eugene Stoudenmire
Malcolm Clarke Edmund Kienast Walter Struppler
Javier Espina Craig Reister John Vergis
Michael Faughn John Rhoads Yu Yuan
Kenneth Fuchs Scott Robertson Oren Yuen
David Fuschi Enrico Rudorf Daidi Zhong
Stefan Schlichting
When the IEEE SA Standards Board approved this standard on 8 November 2023, it had the following
membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Sara R. Biyabani Joseph S. Levy Paul Nikolich
Doug Edwards Howard Li Annette D. Reilly
Ramy Ahmed Fathy Gui Lin Robby Robson
Guido R. Hiertz Johnny Daozhuang Lin Lei Wang
Yousef Kimiagar Xiaohui Liu F. Keith Waters
Joseph L. Koepfinger* Kevin W. Lu Karl Weber
Thomas Koshy Daleep C. Mohla Philip B. Winston
John D. Kulick Andrew Myles Don Wright
*Member Emeritus
ISO/IEEE 11073-10103:2025(en)
Introduction
This introduction is not part of IEEE Std 11073-10103-2023, Health informatics—Device interoperability—Part
10103: Point-of-Care Medical Device Communication—Nomenclature —Implantable Device, Cardiac.
This standard enables and standardizes the reporting of discrete data elements associated with implantable
cardiac device interrogations (observations) to enterprise-based applications (e.g., clinical information
systems).
Information retrieved from implantable cardiac devices is transmitted and stored in centralized health
records using vendor proprietary methods, or in many cases, it is managed as paper documents. By
standardizing the terminology used to describe the settings and measurements of these devices, both the
ordering and follow-up reporting can be integrated more easily with health care applications, such as
electronic health records, order entry systems, and electronic patient records. This integration will result in
greater access to critical patient information and automated verification that clinical orders have been
completed in a timely fashion, ultimately resulting in increased quality of care and patient safety.
Subject domain experts provided the requirements for the nomenclature. Subject domain experts are
represented by members of the Heart Rhythm Society (HRS), which is the international leader in science,
education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information
resource on heart rhythm disorders.
This standard is a distinct and standalone partition within the IEEE 11073-10101 nomenclature. It is meant
to be a self-contained and comprehensive nomenclature for information pertaining to implantable cardiac
devices.
ISO/IEEE 11073-10103:2025(en)
Contents
1. Overview .11
1.1 Scope .11
1.2 Purpose .11
1.3 Word usage .11
1.4 Audience .12
1.5 Context .12
2. Normative references .12
3. Definitions, acronyms, and abbreviations .13
3.1 Definitions .13
3.2 Acronyms and abbreviations .14
4. Introduction to IEEE 11073 implantable devices cardiac domain .15
5. Nomenclature requirements .17
5.1 Overview .17
5.2 Scope requirements .18
5.3 Organizational structure requirements .18
5.4 Semantic requirements.18
6. Nomenclature structure .18
6.1 Overview .18
6.2 Highest level containment nodes .20
7. Conformance .25
7.1 Applicability .25
7.2 Conformance specification .25
7.3 Implementation conformance statements (ICSs) .26
7.4 General ICS .26
7.5 Mandatory ICS .26
7.6 Optional ICS .27
8. Extensibility/versioning .28
Annex A (normative) Base terms .29
A.1 Overview .29
A.2 Base term attributes .29
A.3 Partition details .31
A.4 Table of base terms .32
A.5 Table of discriminators .50
Annex B (informative) Base terms additional properties .52
B.1 Overview .52
B.2 K—Primary key .52
B.3 O—Optionality .52
B.4 C—Cardinality .52
B.5 CC—Co-constraint rules .52
Annex C (normative) Expanded terms with systematic name and codes .54
C.1 Overview .54
C.2 Expanded term attributes .54
C.3 Expanded terms with systematic name and codes (normative) .55
ISO/IEEE 11073-10103:2025(en)
Annex D (normative) Normative enumerations .89
D.1 Overview .89
D.2 Enumeration attributes .89
D.3 Normative Enumerations .91
Annex E (normative) Vendor-specific enumerations .106
E.1 Overview .106
E.2 Enumeration attributes .107
E.3 Vendor-specific enumerations .107
Annex F (informative) Example report .124
Annex G (informative) Implementation notes .129
G.1 Overview .129
G.2 Reference identifiers based on a [HIGHLOW] discriminator .129
G.3 Abnormal flags, null flavors .129
G.4 Maintaining an episode list .129
G.5 Reference identifiers incorporating the [MMM] discriminators (Min, Max, Mean) .130
G.6 Identifiers that include a discriminator with a null value .130
G.7 Measurement and Notification dates and times (_DTM_[STRTEND]) .130
G.8 Measurement dates and times for episode counts (_COUNT_DTM) .130
G.9 Blanking and Refractory .131
G.10 Multiple Episode Statistics .131
G.11 Notification .131
G.12 Battery Remaining Timeframes .132
G.13 Implementation Notes Specific to Reference IDs .133
Annex H (informative) Blanking and refractory period display names .136
H.1 Description .136
H.2 Special situation for V REFRACTORY after RV/LV .136
Annex I (informative) Bibliography .138
ISO/IEEE 11073-10103:2025(en)
Health informatics—Device interoperability

Part 10103: Point-of-Care
Medical Device Communication—
Nomenclature—Implantable Device,
Cardiac
1. Overview
1.1 Scope
This standard 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).
1.2 Purpose
This standard addresses the need for an openly defined, independent standard for representing information
collected from industry-wide implantable cardiac devices. A broader intent is to enable a standards-based
exchange of implantable cardi
...