EN ISO 11073-00103:2017

SLOVENSKI STANDARD
01-september-2017
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 00103. del:
Pregled (ISO/IEEE 11073-00103:2015)
Health informatics - Personal health device communication - Part 00103: Overview
(ISO/IEEE 11073-00103:2015)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit-
Teil 00103: Überblick (ISO/IEEE 11073-00103:2015)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
00103: Aperçu général (ISO/IEEE 11073-00103:2015)
Ta slovenski standard je istoveten z: EN ISO 11073-00103:2017
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
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 11073-00103
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.040.55; 35.240.80
English Version
Health informatics - Personal health device
communication - Part 00103: Overview (ISO/IEEE 11073-
00103:2015)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 00103: Aperçu für die persönliche Gesundheit- Teil 00103: Überblick
général (ISO/IEEE 11073-00103:2015) (ISO/IEEE 11073-00103:2015)
This European Standard was approved by CEN on 16 January 2017.

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, Serbia, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-00103:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/IEEE 11073-00103:2015 has been prepared by Technical Committee ISO/TC 215
“Health informatics” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 11073-00103:2017 by 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 2017, and conflicting national standards shall
be withdrawn at the latest by August 2017.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
Endorsement notice
The text of ISO 11073-00103:2015 has been approved by CEN as EN ISO 11073-00103:2017 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-00103
First edition
2015-03-01
Health informatics — Personal health
device communication —
Part 00103:
Overview
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 00103: Aperçu général
Reference number
ISO/IEEE 11073-00103:2015(E)
©
IEEE 2012
ISO/IEEE 11073-00103:2015(E)
©  IEEE 2012
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Published in Switzerland
ii © IEEE 2012 – All rights reserved

ISO/IEEE 11073-00103:2015(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
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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
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
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entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-00103 was prepared by the 11073 Committee of the Engineering in Medicine and Biology
Society of the IEEE (as IEEE 11073-00103-2012). It was adopted by Technical Committee ISO/TC 215,
Health informatics, 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

ISO/IEEE 11073-00103:2015(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 10442: (Point-of-care medical device communication) Device specialization — Strength fitness
equipment
 Part 10471: Device specialization — Independent 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—Personal health device communication

Part 00103: Overview
IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standard Committee

IEEE
IEEE Std 11073-00103™-2012
3 Park Avenue
New York, NY 10016-5997
USA
31 August 2012
TM
IEEE Std 1173-00103 -2012
Health informatics—Personal health device communication
Part 00103: Overview
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 14 May 2012
IEEE-SA Standards Board
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, the landscape of transport-independent applications and information profiles for
personal telehealth devices is described in this guide. Defined in these profiles are data exchange,
data representation, and terminology for communication between personal telehealth devices and
compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). A
definition of personal telehealth devices as devices used for life activity, wellness monitoring,
and/or health monitoring in domestic home, communal home, and/or mobile applications is
provided in this guide. Use cases relevant to these scenarios and environments are also
presented.
Keywords: IEEE 11073-00103, medical device communication, personal health devices

•
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA

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