SIST EN ISO 11073-10103:2014
(Main)Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature: Implantable device, cardiac (ISO 11073-10103:2013, Corrected version 2014-05-01)
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature: Implantable device, cardiac (ISO 11073-10103:2013, Corrected version 2014-05-01)
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).
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil 10103: Nomenklatur - Implantierbare kardiologische Geräte (ISO/IEEE 11073-10103:2014, korrigierte Fassung 2014-05-01)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 10103: Nomenclature: Dispositif implantable, cardiaque (IS0 11073-10103:2013)
L'ISO 11073-10103:2013 étend la nomenclature de base fournie dans l'ISO/IEEE 11073-10101:2004 afin de prendre en charge la terminologie relative aux dispositifs cardiaques implantables. Les dispositifs relevant du domaine d'application de cette nomenclature sont des dispositifs implantables tels que les stimulateurs cardiaques, les défibrillateurs, les dispositifs de resynchronisation cardiaque et les moniteurs cardiaques implantables. Cette nomenclature définit les termes discrets nécessaires pour fournir un résumé cliniquement significatif des informations obtenues durant l'interrogation d'un dispositif. Les extensions de la nomenclature peuvent être utilisées conjointement avec d'autres composantes des normes IEEE 11073, telles que l'ISO/IEEE 11073-10201 [B2], ou avec d'autres normes, telles que la norme Health Level Seven International (HL7).
L'ISO 11073-10103:2013 répond à la nécessité de se doter d'une norme indépendante et définie de façon ouverte pour représenter les informations recueillies par les dispositifs cardiaques implantables dans l'ensemble du secteur. Elle vise plus globalement à permettre un échange, basé sur des normes, des informations des dispositifs cardiaques implantables entre les systèmes d'interrogation propriétaires des fournisseurs et les systèmes de dossiers médicaux informatisés des centres de cardiologie.
Zdravstvena informatika - Komunikacija medicinskih naprav na mestu oskrbe - 10103. del: Nomenklatura: Pripomoček za vsaditev, srčni (ISO 11073-10103:2013, popravljena različica 2014-05-01)
Ta standard razširja osnovno nomenklaturo, podano v standardu ISO/IEEE 11073-10101:2004 za zagotavljanje podpore glede terminologije za srčne vsadne pripomočke. Pripomočki v okviru te nomenklature so pripomočki za vsaditev, kot so srčni spodbujevalniki, defibrilatorji, pripomočki za resinhronizacijsko zdravljenje in vsadki za spremljanje srčne aktivnosti. Ta nomenklatura opredeljuje ločene izraze, potrebne za posredovanje klinično relevantnega povzetka informacij, pridobljenih med preiskovanjem pripomočka. Nomenklaturne razširitve je mogoče uporabljati skupaj z drugimi sestavnimi deli standarda IEEE 11073 (npr., ISO/IEEE 11073-10201 [B2]) ali z drugimi standardi, kot je mednarodna skupina standardov Health Level 7 (HL7).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11073-10103:2014
01-julij-2014
Zdravstvena informatika - Komunikacija medicinskih naprav na mestu oskrbe -
10103. del: Nomenklatura: Pripomoček za vsaditev, srčni (ISO 11073-10103:2013,
popravljena različica 2014-05-01)
Health informatics - Point-of-care medical device communication - Part 10103:
Nomenclature: Implantable device, cardiac (ISO 11073-10103:2013, Corrected version
2014-05-01)
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
SIST EN ISO 11073-10103:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11073-10103:2014
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SIST EN ISO 11073-10103:2014
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, Corrected version 2014-05-01)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation patientennaher
médicaux sur le site des soins - Partie 10103: medizinischer Geräte - Teil 10103: Nomenklatur -
Nomenclature - Dispositif implantable, cardiaque (ISO/IEEE Implantierbare kardiologische Geräte (ISO/IEEE 11073-
11073-10103:2014, Version corrigée 2014-05-01) 10103:2014, korrigierte Fassung 2014-05-01)
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.
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SIST EN ISO 11073-10103:2014
EN ISO 11073-10103:2013 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11073-10103:2014
EN ISO 11073-10103:2013 (E)
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, Corrected version 2014-05-01 has been approved by CEN as
EN ISO 11073-10103:2013 without any modification.
3
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SIST EN ISO 11073-10103:2014
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SIST EN ISO 11073-10103:2014
INTERNATIONAL ISO/IEEE
STANDARD 11073-
10103
First edition
2014-03-01
Corrected version
2014-05-01
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
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SIST EN ISO 11073-10103:2014
ISO/IEEE 11073-10103:2014(E)
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ISO version published 201
Published in Switzerland
ii © IEEE 2012 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11073-10103:2014
ISO/IEEE 11073-10103:2014(E)
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
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IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards
through a consensus development process, approved by the American National Standards Institute, which
brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers
are not necessarily members of the Institute and serve without compensation. While the IEEE administers the
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The main task of technical committees is to prepare International Standards. Draft International Standards
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Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
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patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
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ISO/IEEE 11073-10103 was prepared by the Substations Committee of the IEEE Power Engineering Society
of the IEEE (as IEEE 11073-10103-2013). It was adopted by Technical Committee ISO/TC 215, Lung
ventilators, in parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in
the Partner Standards Development Organization cooperation agreement between ISO and IEEE. IEEE is
responsible for the maintenance of this document with participation and input from ISO member bodies.
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
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SIST EN ISO 11073-10103:2014
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
This corrected version of ISO 11073-10417:2014 incorporates the following correction:
the text "Authorized licensed use limited to: IEEE Standards Staff and authorized IEEE Sponsor Ballot
Participants. Downloaded on May 28,2013 at 14:27:23 UTC from IEEE Xplore. Restrictions apply." has
been deleted from the footer.
iv © IEEE 2012 – All rights reserved
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SIST EN ISO 11073-10103:2014
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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SIST EN ISO 11073-10103:2014
---------------------- Page: 12 ----------------------
SIST EN ISO 11073-10103:2014
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
---------------------- Page: 13 ----------------------
SIST EN ISO 11073-10103:2014
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
•
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Copyright © 2012 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 27 August 2012. Printed in the United States of America.
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PDF: ISBN 978-0-7381-7282-8 STD97257
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of the publisher.
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SIST EN ISO 11073-10103:2014
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SIST EN ISO 11073-10103:2014
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iv
Copyright © 2012 IEEE. All rights reserved.
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SIST EN ISO 11073-10103:2014
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
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their own responsibility. Further information may be obtained from the IEEE Standards Association.
v
Copyright © 2012 IEEE. All rights reserved.
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SIST EN ISO 11073-10103:2014
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/.
vi
Copyright © 2012 IEEE. All rights reserved.
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SIST EN ISO 11073-10103:2014
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 .
...
SLOVENSKI STANDARD
SIST EN ISO 11073-10103:2014
01-julij-2014
=GUDYVWYHQDLQIRUPDWLND.RPXQLNDFLMDPHGLFLQVNLKQDSUDYQDPHVWXRVNUEH
GHO 1RPHQNODWXUD 3ULSRPRþHN]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
SIST EN ISO 11073-10103:2014 en,fr,de
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SIST EN ISO 11073-10103:2014
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SIST EN ISO 11073-10103:2014
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.
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SIST EN ISO 11073-10103:2014
EN ISO 11073-10103:2013 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11073-10103:2014
EN ISO 11073-10103:2013 (E)
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.
3
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SIST EN ISO 11073-10103:2014
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SIST EN ISO 11073-10103:2014
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
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SIST EN ISO 11073-10103:2014
ISO/IEEE 11073-10103:2014(E)
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ISO version published 2013
Published in Switzerland
ii © IEEE 2012 – All rights reserved
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SIST EN ISO 11073-10103:2014
ISO/IEEE 11073-10103:2014(E)
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.
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards
through a consensus development process, approved by the American National Standards Institute, which
brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers
are not necessarily members of the Institute and serve without compensation. While the IEEE administers the
process and establishes rules to promote fairness in the consensus development process, the IEEE does not
independently evaluate, test, or verify the accuracy of any of the information contained in its standards.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential
patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if
any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-10103 was prepared by the Substations Committee of the IEEE Power Engineering Society
of the IEEE (as IEEE 1686-2007). It was adopted by Technical Committee ISO/TC 215, Lung ventilators, in
parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in the Partner
Standards Development Organization cooperation agreement between ISO and IEEE. IEEE is responsible for
the maintenance of this document with participation and input from ISO member bodies.
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
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SIST EN ISO 11073-10103:2014
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
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SIST EN ISO 11073-10103:2014
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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SIST EN ISO 11073-10103:2014
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SIST EN ISO 11073-10103:2014
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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SIST EN ISO 11073-10103:2014
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
•
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3 Park Avenue, New York, NY 10016-5997, USA
Copyright © 2012 by The Institute of Electrical and Electronics Engineers, Inc.
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SIST EN ISO 11073-10103:2014
Notice and Disclaimer of Liability Concerning the Use of IEEE Documents: IEEE Standards documents are developed
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Standards Board. IEEE develops its standards through a consensus development process, approved by the American National
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SIST EN ISO 11073-10103:2014
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SIST EN ISO 11073-10103:2014
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
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Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely
their own responsibility. Further information may be obtained from the IEEE Standards Association.
v
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SIST EN ISO 11073-10103:2014
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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SIST EN ISO 11073-10103:2014
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 2
1.3 Audience .
...
Questions, Comments and Discussion
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