ISO/IEEE 11073-10103:2025

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
© IEEE 2024
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© IEEE 2024 – All rights reserved
ii
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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ISO document should be noted (see www.iso.org/directives).
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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
— 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
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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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
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.
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
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
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 cardiac device information between vendor’s proprietary interrogation systems
and clinic electronic medical record systems.
1.3 Word usage
The word shall indicates mandatory requirements strictly to be followed in order to conform to the standard
8,9
and from which no deviation is permitted (shall equals is required to).

Information on references can be found in Clause 2.
The numbers in brackets correspond to those of the bibliography in Annex I.
The use of the word must is deprecated when stating mandatory requirements; must is used only to describe unavoidable situations.
The use of will is deprecated when stating mandatory requirements; will is only used in statements of fact.
IEEE Std 11073-10103-2023
Health Informatics—Device Interoperability—Part 10103: Point-of-Care Medical Device Communication
Nomenclature—Implantable Device, Cardiac
The word should indicates that among several possibilities one is recommended as particularly suitable
without mentioning or excluding others; or that a certain course of action is preferred but not necessarily
required (should equals is recommended that).
The word may is used to indicate a course of action permissible within the limits of the standard (may
equals is permitted to).
The word can is used for statements of possibility and capability, whether material, physical, or causal (can
equals is able to).
1.4 Audience
The audience for this document is those who work with implantable cardiac device information in the
context of systems integration. This may include but is not limited to the following roles:
⎯ Cardiologist or electrophysiologist physicians
⎯ Heart failure physicians
⎯ Heart and device clinic specialists or staff
⎯ Primary care physicians
⎯ Clinic information technologists
⎯ Clinic information system vendor engineers
⎯ Implantable cardiac device vendor engineers
⎯ Regulatory and quality management agencies
1.5 Context
This nomenclature has been developed within the context of the broader 11073 Health informatics—Point
of care medical device communication standards. Its goal is to be consistent with existing 11073 standards
and information models.
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so each referenced document is cited in text and its relationship to this document is
explained). For dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments or corrigenda) applies.
IHE Patient Care Device (PCD) Technical Framework, Volume 1, IHE PCD TF-1, Profiles (Revision 7.0 –
Final Text, December 12, 2019).
IHE Patient Care Device (PCD) Technical Framework, Volume 2, IHE PCD TF-2, Transactions (Revision
7.0 – Final Text, December 12, 2019).

Volume 1 of the IHE Patient Care Devices Technical Framework is available at http://www.ihe.net/uploadedFiles/Documents
/PCD/IHE_PCD_TF_Vol1.pdf.
Volume 2 of the IHE Patient Care Devices Technical Framework is available at http://www.ihe.net/uploadedFiles/Documents
/PCD/IHE_PCD_TF_Vol2.pdf.
IEEE Std 11073-10103-2023
Health Informatics—Device Interoperability—Part 10103: Point-of-Care Medical Device Communication
Nomenclature—Implantable Device, Cardiac
ISO/IEEE 11073-10101:2020, Health informatics—Device Interoperability—Part 10101: Point-of-care
medical device communication—Nomenclature.
The Unified Code for Units of Measure (UCUM), version 2.1.
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this document, the following terms and definitions apply. The IEEE Standards
Dictionary Online should be consulted for terms not defined in this clause.
arrhythmia: Any abnormality of cardiac rhythm. Examples are bradycardia, dysrhythmia, and tachycardia.
cardiac monitors: A device that shows the electrical waveforms of the cardiovascular system for
measurement and treatment.
cardiac resynchronization therapy: A treatment that can relieve congestive heart failure symptoms by
improving the coordination of the heart’s contractions.
cardiologist: Physician specializing in disorders of the heart.
centralized health record: See: electronic health records (EHR).
clinic information system vendor engineers: Personnel employed by the clinic to create, enhance, and
maintain the computerized information systems that reside in a clinic.
co-constraint: A rule describing a constraint whose scope is inclusive of more than one term.
constraint: A restriction on the set of values being assigned.
containment node: An intermediate node within the containment hierarchy (tree graph) of the
nomenclature.
defibrillator: See: implantable cardioverter defibrillator (ICD).
device clinic: A specialized physician clinic that provides follow-up service to patients with an implanted
pacemaker or cardioverter defibrillator (ICD).
discriminators: A mechanism to provide additional semantic refinement to multiple terms.
domain information model (DIM): The model describing common concepts and relationships for a
problem domain.
ISO/IEEE publications are available from the International Organization for Standardization (https://www.iso.org/) and The Institute
of Electrical and Electronics Engineers (https://standards.ieee.org/).
UCUM is available at https://ucum.org/ucum.html. An overview and useful supporting information are available at
https://unitsofmeasure.org/.
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to the dictionary, and one can be created at no charge on the dictionary sign-in page.
IS
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