SIST EN ISO 11073-10103:2014

SLOVENSKI STANDARD
SIST EN ISO 11073-10103:2014
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
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)
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.


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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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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
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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
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
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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
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scope of patents or patent claims or determining whether any licensing terms or conditions provided in
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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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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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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
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Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
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inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
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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/.
vi
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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 .
...