EN ISO 11073-10103:2013

SLOVENSKI STANDARD
01-julij-2014
=GUDYVWYHQDLQIRUPDWLND.RPXQLNDFLMDPHGLFLQVNLKQDSUDYQDPHVWXRVNUEH
GHO1RPHQNODWXUD3ULSRPRþHN]DYVDGLWHYVUþQL,62
Health informatics - Point-of-care medical device communication - Part 10103:
Nomenclature: Implantable device, cardiac (ISO 11073-10103:2013)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 10103: Nomenclature: Dispositif implantable, cardiaque (IS0 11073-10103:2013)
Ta slovenski standard je istoveten z: EN ISO 11073-10103:2013
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.

EUROPEAN STANDARD
EN ISO 11073-10103
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2013
ICS 35.240.80
English Version
Health informatics - Point-of-care medical device communication
- Part 10103: Nomenclature - Implantable device, cardiac
(ISO/IEEE 11073-10103:2014)
Informatique de santé - Communication entre dispositifs
médicaux sur le site des soins - Partie 10103:
Nomenclature - Dispositif implantable, cardiaque (ISO/IEEE
11073-10103:2014)
This European Standard was approved by CEN on 14 December 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10103:2013 E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11073-10103:2013) 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 August 2014, and conflicting national standards shall be withdrawn at
the latest by August 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10103:2014 has been approved by CEN as EN ISO 11073-10103:2013 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-
First edition
2014-03-01
Health informatics — Point-of-care
medical device communication —
Part 10103:
Nomenclature — Implantable device,
cardiac
Informatique de santé — Communication entre dispositifs médicaux sur
le site des soins
Partie 10103: Nomenclature — Dispositif implantable, cardiaque

Reference number
ISO/IEEE 11073-10103:2014(E)
©
IEEE 2012
ISO/IEEE 11073-10103:2014(E)
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ISO/IEEE 11073-10103:2014(E)
Foreword
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ISO/IEEE 11073-10103 was prepared by the Substations Committee of the IEEE Power Engineering Society
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ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health
device communication (text in parentheses gives a variant of subtitle):
 Part 00103: Overview
 Part 10101: (Point-of-care medical device communication) Nomenclature
 Part 10102: (Point-of-care medical device communication) Nomenclature — Annotated ECG
 Part 10103: (Point-of-care medical device communication) — Nomenclature — Implantable device,
cardiac
 Part 10201: (Point-of-care medical device communication) Domain information model
 Part 10404: Device specialization — Pulse oximeter
© IEEE 2012 – All rights reserved iii

ISO/IEEE 11073-10103:2014(E)
 Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
 Part 10407: Device specialization — Blood pressure monitor
 Part 10408: Device specialization — Thermometer
 Part 10415: Device specialization — Weighing scale
 Part 10417: Device specialization — Glucose meter
 Part 10418: Device specialization — International Normalized Ratio (INR) monitor
 Part 10420: Device specialization — Body composition analyzer
 Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
 Part 10441: Device specialization — Cardiovascular fitness and activity monitor
 Part 10471: Device specialization — Independant living activity hub
 Part 10472: Device specialization — Medication monitor
 Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
 Part 20601: Application profile — Optimized exchange protocol
 Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
 Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
 Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
 Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
 Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
— Part 92001: (Medical waveform format) — Encoding rules
iv © IEEE 2012 – All rights reserved

Health informatics—Point-of-care medical device communication

Part 10103: Nomenclature—Implantable device,
cardiac
IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standard Committee

IEEE
IEEE Std 11073-10103™-2012
3 Park Avenue
New York, NY 10016-5997
USA
27 August 2012
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TM
IEEE Std 11073-10103 -2012
Health informatics—Point-of-care medical device communication
Part 10103: Nomenclature—Implantable device,
cardiac
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 14 May 2012
IEEE-SA Standards Board
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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 (CRT), codes, follow-up, home monitoring,
IEEE 11073-10103, implantable cardioverter defibrillator (ICD), implantable devices, 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

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Introduction
This introduction is not part of IEEE Std 11073-10103-2012, Health informatics—Point-of-care medical device
communication—Part 10103: 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). Currently, no such standardization exists, typically resulting in the reports being managed as
paper documents and not electronically.
Given the lack of standardization in this domain, 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.
NOTE—The XML Schema, XSLT transforms and XML data files contained in Annex H are available at the following
URL: http://standards.ieee.org/downloads/11073/11073-10103-2012/.
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Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 2
1.3 Audience . 2
1.4 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 4
4. Introduction to IEEE 11073 implantable devices cardiac domain . 5
5. Nomenclature requirements . 7
5.1 Overview . 7
5.2 Scope requirements . 7
5.3 Organizational structure requirements . 7
5.4 Semantic requirements. 7
6. Nomenclature structure . 8
6.1 Overview . 8
6.2 Highest level containment nodes . 10
7. Conformance . 14
7.1 Applicability . 14
7.2 Conformance specification . 14
7.3 Implementation conformance statements (ICSs) . 14
7.4 General ICS . 15
7.5 Mandatory ICS . 15
7.6 Optional ICS . 16
8. Extensibility/versioning . 17
Annex A (normative) Base terms . 18
Annex B (informative) Base terms additional properties . 31
Annex C (normative) Expanded terms with systematic name and codes . 33
Annex D (normative) Enumerations . 47
Annex E (informative) Vendor enumerations . 58
Annex F (informative) Example report . 70
Annex G (informative) Implementation notes . 73
Annex H (informative) Schema and XML for nomenclature . 75
Annex I (informative) Bibliography .115
Annex J (informative) IEEE list of participants.116
YLi
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ISO/IEEE 11073-1010:2014(E)
Health informatics—Point-of-care medical device communication
Part 10103: Nomenclature—Implantable device,
cardiac
IMPORTANT NOTICE: IEEE Standards documents are not intended to ensure safety, health, or
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1. Overview
1.1 Scope
This standard extends the base nomenclature provided in ISO/IEEE 11073-10101:2004 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 discrete 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).

Information on references can be found in Clause 2.
The numbers in brackets correspond to those of the bibliography in Annex I.
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ISO/IEEE 11073-1010:2014(E)
IEEE Std 11073-10103-2012
Health informatics—Point-of-care medical device communication
Part 10103: Nomenclature—Implantable device, cardiac

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 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
1.4 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 that 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.
ISO/IEEE 11073-10101:2004, Health informatics—Point-of-care medical device communication—Part
10101: Nomenclature.
The Unified Code for Units of Measure (UCUM), version 1.8.

ISO/IEC publications are available from the ISO Central Secretariat (http://www.iso.org/). ISO publications are also available in the
United States from the American National Standards Institute (http://www.ansi.org/).
UCUM is available at http://aurora.regenstrief.org/~ucum/ucum.html. An overview and useful supporting information are available
at http://unitsofmeasure.org/.
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ISO/IEEE 11073-1010:2014(E)
IEEE Std 11073-10103-2012
Health informatics—Point-of-care medical device communication
Part 10103: Nomenclature—Implantable device, cardiac
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.
electronic health records (EHR): A longitudinal collection of electronic health information about
individual patients or populations. It is a record in digital format that is capable of being shared within
across different health care settings by being embedded in network-connected enterprise-wide information
system.
electrophysiologist: A physician with advanced study of the electrical properties of the heart.
implantable cardiac device: A small, battery-powered electrical impulse generator that is implanted in
patients to maintain heart rate or deliver a high-powered shock to correct cardiac arrhythmia. See also:
defibrillator; pacemaker.
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ISO/IEEE 11073-1010:2014(E)
IEEE Std 11073-10103-2012
Health informatics—Point-of-care medical device communication
Part 10103: Nomenclature—Implantable device, cardiac
implantable cardiac device vendor engineers: Personnel employed by the implantable cardiac device
vendors who create, enhance, and maintain the computerized information systems that support their
devices.
implantable cardioverter defibrillator (ICD): A small, battery-powered electrical impulse generator that
is implanted in patients who are at risk of sudden cardiac death. The device is programmed to detect cardiac
arrhythmia and correct it by delivering a shock of electric current.
interrogation: The process of communicating with and retrieving data from an implantable medical
device.
nomenclature: A set of names or terms comprising a taxonomy for a specific domain.
pacemaker: A small, battery-powered electrical impulse generator which is implanted in patients to
support or maintain heart rate.
programming: The noninvasive adjustment of programmable parameters in a implantable cardiac device.
reference ID: A unique, symbolic, and programmatic form for the term. The form is correlated to the
context-free code (i.e., titles are by definition context-free with respect to all other titles); all terms are
prefixed with “MDC_IDC_” for consistency.
rhythm disturbance: An irregular heartbeat.
systematic name: An organization of differentiating, relational descriptors that are unique for each term.
terminology: A synonym for nomenclature.
vendor enumerations: Vendor-specific enumerated values for a term.
vendor proprietary equipment: Device vendor equipment or systems used for management and analysis
of devices.
3.2 Acronyms and abbreviations

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