SIST EN ISO 11073-10418:2014

Health informatics - Personal health device communication - Part 10418: Device specialization: International Normalized Ratio (INR) monitor (ISO 11073-10418:2014, Corrected version 2014-05-01)

The scope of this standard is to establish a normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of functionality of INR devices. In the context of personal health devices, INR monitoring refers to the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. This standard provides the data modeling and its transport shim layer according to IEEE Std 11073-20601aTM-2010 and does not specify the measurement method.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10418: Gerätespezifikation - Monitor für den international standardisierter Thromboplastinzeit-Quotient (INR) (ISO 11073-10418:2014)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10418: Spécialisation des dispositifs: surveillance du rapport normalisé international (INR) (ISO 11073-10418:2014)

L'ISO/IEEE 11073-10418:2014 établit une définition normative de la communication entre des dispositifs (agents) de surveillance du rapport normalisé international (INR) personnels de télésanté et des gestionnaires (par exemple des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et des boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Il s'appuie sur le travail réalisé dans d'autres normes ISO/IEEE 11073, y compris la terminologie, des modèles d'informations, des normes de profils d'applications et des normes de transport. Elle spécifie l'utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l'interopérabilité. L'ISO/IEEE 11073-10418:2014 définit un noyau commun de fonctionnalités des dispositifs de surveillance de l'INR. Dans le contexte des dispositifs personnels de santé, la surveillance de l'INR se rapporte au mesurage du temps de prothrombine (TP) utilisé pour évaluer la dose de traitement anticoagulant et à sa présentation sous forme de comparaison entre le rapport normalisé international et le temps de prothrombine du plasma sanguin normal. Les applications du moniteur de surveillance de l'INR incluent la gestion de la dose thérapeutique de l'anticoagulant utilisé dans le traitement de diverses pathologies. L'ISO/IEEE 11073-10418:2014 fournit la modélisation des données et leur couche de calage de transport conformément à l'IEEE 11073-20601a-2010 et ne spécifie pas la méthode de mesurage.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10418. del: Specialne naprave - Monitor za mednarodno umerjeno razmerje (INR) (ISO 11073-10418:2014, popravljena različica 2014-05-01)

Področje uporabe tega standarda določa normativno opredelitev komunikacije med osebnimi telemedicinskimi napravami za mednarodno umerjeno razmerje (agenti) in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami in digitalnimi sprejemniki) na način, ki omogoča interoperabilnost s takojšnjim učinkom („vstavi in poženi“). Standard temelji na delu, doseženem v drugih standardih ISO/IEEE 11073, vključno z obstoječo terminologijo, informacijskimi profili, standardi za profile aplikacije in standardi za prevoz. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih, kjer v korist interoperabilnosti omejuje izbirnost osnovnih okvirov. Ta standard določa skupno jedro funkcionalnosti za napravo za mednarodno umerjeno razmerje (INR). Monitor za mednarodno umerjeno razmerje (INR) se v okviru osebnih medicinskih pripomočkov uporablja za merjenje protrombinskega časa (PT), ki se uporablja za ocenjevanje stopnje antikoagulantne terapije in njene predstavitve kot mednarodno umerjenega razmerja v primerjavi s protrombinskim časom običajne krvne plazme. Uporabe monitorja za mednarodno umerjeno razmerje (INR) vključujejo upravljanje terapevtske stopnje antikoagulantov, uporabljenih pri zdravljenju različnih bolezni. Ta standard vsebuje podatke za modeliranje in plast podložke za transport po standardu IEEE 11073-20601aTM-2010 ter ne določa merske metode.

General Information

• Status: Published
• Publication Date: 03-Jun-2014
• ICS: 11.040.01 - Medical equipment in general
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Mar-2014
• Due Date: 24-May-2014
• Completion Date: 04-Jun-2014
• Ref Project: EN ISO 11073-10418:2014 - Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor (ISO/IEEE 11073-10418:2014, Corrected version 2014-05-01)

Relations

• Corrected By: SIST EN ISO 11073-10418:2014/AC:2017 - Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
• Effective Date: 17-Feb-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11073-10418:2014
01-julij-2014
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10418. del:
Specialne naprave - Monitor za mednarodno umerjeno razmerje (INR) (ISO 11073-
10418:2014, popravljena različica 2014-05-01)
Health informatics - Personal health device communication - Part 10418: Device
specialization: International Normalized Ratio (INR) monitor (ISO 11073-10418:2014,
Corrected version 2014-05-01)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10418: Gerätespezifikation - Monitor für den international standardisierter
Thromboplastinzeit-Quotient (INR) (ISO 11073-10418:2014)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10418: Spécialisation des dispositifs: surveillance du rapport normalisé international
(INR) (ISO 11073-10418:2014)
Ta slovenski standard je istoveten z: EN ISO 11073-10418:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10418:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-10418:2014

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SIST EN ISO 11073-10418:2014

EUROPEAN STANDARD
EN ISO 11073-10418

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2014
ICS 35.240.80
English Version
Health informatics - Personal health device communication - Part
10418: Device specialization - International Normalized Ratio
(INR) monitor (ISO/IEEE 11073-10418:2014, Corrected version
2014-05-01)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation von Geräten für
médicaux sur le site des soins - Partie 10418: die persönliche Gesundheit - Teil 10418:
Spécialisation des dispositifs - Surveillance du rapport Gerätespezifikation - Monitor für den international
normalisé international (INR) (ISO/IEEE 11073-10418:2014, standardisierter Thromboplastinzeit-Quotient (INR)
Version corrigée 2014-05-01) (ISO/IEEE 11073-10418:2014, 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10418:2014 E
worldwide for CEN national Members.

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SIST EN ISO 11073-10418:2014
EN ISO 11073-10418:2014 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 11073-10418:2014
EN ISO 11073-10418:2014 (E)
Foreword
This document (EN ISO 11073-10418:2014) 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 September 2014, and conflicting national standards shall be
withdrawn at the latest by September 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 11073-10418:2014, Corrected version 2014-05-01 has been approved by CEN as
EN ISO 11073-10418:2014 without any modification.


3

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SIST EN ISO 11073-10418:2014

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SIST EN ISO 11073-10418:2014

INTERNATIONAL ISO/IEEE
STANDARD 11073-
10418
First edition
2014-03-01
Corrected version
2014-05-01

Health informatics — Personal health
device communication —
Part 10418:
Device specialization: International
Normalized Ratio (INR) monitor
Informatique de santé — Communication entre dispositifs de santé
personnels
Partie 10418: Spécialisation de dispositif: surveillance du rapport
normalisé international (INR)




Reference number
ISO/IEEE 11073-10418:2014(E)

©
IEEE 2011

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SIST EN ISO 11073-10418:2014
ISO/IEEE 11073-10418:2014(E)
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ii © IEEE 2011 – All rights reserved

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SIST EN ISO 11073-10418:2014
ISO/IEEE 11073-10418:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
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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
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
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Attention is called to the possibility that implementation of this standard may require the use of subject matter
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entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-10418 was prepared by the Substations Committee of the IEEE Power Engineering Society
of the IEEE (as IEEE 11073-10418-2011). It was adopted by Technical Committee ISO/TC 215, Respiratory
and anaesthetic equipment, 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 2011 – All rights reserved iii

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SIST EN ISO 11073-10418:2014
ISO/IEEE 11073-10418:2014(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 2011 – All rights reserved

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SIST EN ISO 11073-10418:2014
�
�
Health informatics—Personal health device communication
Part 10418: Device specialization—�
International Normalized Ratio (INR) monitor
�
IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standards Committee
�

IEEE
IEEE Std 11073-10418™�2011
3 Park Avenue
New York, NY 10016-5997
USA

9 November 2011

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SIST EN ISO 11073-10418:2014

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SIST EN ISO 11073-10418:2014
TM
IEEE Std 11073-10418 -2011
Health informatics—Personal health device communication
Part 10418: Device specialization—
International Normalized Ratio (INR) monitor
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 10 September 2011
IEEE-SA Standards Board

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SIST EN ISO 11073-10418:2014
Abstract: A normative definition of communication between personal telehealth International
Normalized Ratio (INR) devices (agents) and managers (e.g. cell phones, personal computers,
personal health appliances, and set top boxes) is established in this sta ndard in a manner that
enables plug-and-play interoperability. Work done in other IS O/IEEE 11073 standards is
leveraged, including existing terminology, information profiles, application profile standards, and
transport standards. T he use of specific term codes, formats, and behaviors in tele health
environments restricting optionality in base frameworks in favor of interoperability is specified. A
common core of functionality of INR devices is defined in this standard. In the context of personal
health devices, the measurement of the prothrombin time (PT) that is used to assess the lev el of
anticoagulant therapy and its presentation as the International Normalized Ratio compared to the
prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR
monitor include the management of the therapeutic level of anticoagulant used in the treatment of
a variety of conditions. The data modeling and its transport shim layer according to ISO/IE EE
11073-20601:2010 are provided by this standard, and the measurement method is not specified.
Keywords: IEEE 11073-10418, International Normalized Ratio (INR) monitor, medical device
communication, personal health devices
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of the publisher.

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SIST EN ISO 11073-10418:2014
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SIST EN ISO 11073-10418:2014
Introduction
This introduction is not part of IEEE Std 11073-10418-2011, Health informatics—Personal health device
communication—Part 10418: Device specialization—International Normalized Ratio (INR) monitor.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
systems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this
standard establishes a normative definition of the communication between medication monitoring devices
and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a
manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards
including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes,
formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of
interoperability. This standard defines a common core of communication functionality for personal
telehealth INR devices. In this context, the measurement of the prothrombin time (PT) that is used to assess
the level of anticoagulant therapy and its presentation as the International Normalized Ratio (INR)
compared with the PT of normal blood plasma is referred to in INR monitoring. Applications of the INR
monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety
of conditions.
Notice to users
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iv
Copyright © 2011 IEEE. All rights reserved.

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SIST EN ISO 11073-10418:2014
Errata
Errata, if any, for this and all other standards can be accessed at the following URL:
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http://standards.ieee.org/findstds/interps/index.html.
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 with respect to the existence
or validity of any patent rights in connection therewith. 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
Copyright © 2011 IEEE. All rights reserved.

---------------------- Page: 17 ----------------------
SIST EN ISO 11073-10418:2014
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 2
1.3 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 3
4. Introduction to ISO/IEEE 11073 personal health devices . 4
4.1 General . 4
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 4
4.3 Compliance with other standards . 5
5. INR monitor device concepts and modalities . 5
5.1 General . 5
5.2 Prothrombin time .
...

SLOVENSKI STANDARD
SIST EN ISO 11073-10418:2014
01-julij-2014
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10418. del:
Specialne naprave - Monitor za mednarodno umerjeno razmerje (INR) (ISO 11073-
10418:2014)
Health informatics - Personal health device communication - Part 10418: Device
specialization: International Normalized Ratio (INR) monitor (ISO 11073-10418:2014)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10418: Gerätespezifikation - Monitor für den international standardisierter
Thromboplastinzeit-Quotient (INR) (ISO 11073-10418:2014)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10418: Spécialisation des dispositifs: surveillance du rapport normalisé international
(INR) (ISO 11073-10418:2014)
Ta slovenski standard je istoveten z: EN ISO 11073-10418:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10418:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11073-10418:2014

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SIST EN ISO 11073-10418:2014

EUROPEAN STANDARD
EN ISO 11073-10418

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2014
ICS 35.240.80
English Version
Health informatics - Personal health device communication - Part
10418: Device specialization - International Normalized Ratio
(INR) monitor (ISO/IEEE 11073-10418:2014, Corrected version
2014-05-01)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation von Geräten für
médicaux sur le site des soins - Partie 10418: die persönliche Gesundheit - Teil 10418:
Spécialisation des dispositifs - Surveillance du rapport Gerätespezifikation - Monitor für den international
normalisé international (INR) (ISO/IEEE 11073-10418:2014, standardisierter Thromboplastinzeit-Quotient (INR)
Version corrigée 2014-05-01) (ISO/IEEE 11073-10418:2014, 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10418:2014 E
worldwide for CEN national Members.

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SIST EN ISO 11073-10418:2014
EN ISO 11073-10418:2014 (E)
Contents Page
Foreword .3
2

---------------------- Page: 4 ----------------------

SIST EN ISO 11073-10418:2014
EN ISO 11073-10418:2014 (E)
Foreword
This document (EN ISO 11073-10418:2014) 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 September 2014, and conflicting national standards shall be
withdrawn at the latest by September 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 11073-10418:2014, Corrected version 2014-05-01 has been approved by CEN as
EN ISO 11073-10418:2014 without any modification.


3

---------------------- Page: 5 ----------------------

SIST EN ISO 11073-10418:2014

---------------------- Page: 6 ----------------------

SIST EN ISO 11073-10418:2014

INTERNATIONAL ISO/IEEE
STANDARD 11073-
First edition
2014-03-01

Health informatics — Personal health
device communication —
Part 10418:
Device specialization: International
Normalized Ratio (INR) monitor
Informatique de santé — Communication entre dispositifs de santé
personnels
Partie 10418: Spécialisation de dispositif: surveillance du rapport
normalisé international (INR)




Reference number
ISO/IEEE 11073-10418:2014(E)

©
IEEE 2011

---------------------- Page: 7 ----------------------

SIST EN ISO 11073-10418:2014
ISO/IEEE 11073-10418:2014(E)
PDF disclaimer
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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Published in Switzerland

ii © IEEE 2011 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 11073-10418:2014
ISO/IEEE 11073-10418:2014(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 11073-10418 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, Respiratory and
anaesthetic equipment, 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 2011 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 11073-10418:2014
ISO/IEEE 11073-10418:2014(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 2011 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 11073-10418:2014
�
�
Health informatics—Personal health device communication
Part 10418: Device specialization—�
International Normalized Ratio (INR) monitor
�
IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standards Committee
�

IEEE
IEEE Std 11073-10418™�2011
3 Park Avenue
New York, NY 10016-5997
USA

9 November 2011
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---------------------- Page: 11 ----------------------

SIST EN ISO 11073-10418:2014
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---------------------- Page: 12 ----------------------

SIST EN ISO 11073-10418:2014
TM
IEEE Std 11073-10418 -2011
Health informatics—Personal health device communication
Part 10418: Device specialization—
International Normalized Ratio (INR) monitor
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 10 September 2011
IEEE-SA Standards Board
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---------------------- Page: 13 ----------------------

SIST EN ISO 11073-10418:2014
Abstract: A normative definition of communication between personal telehealth International
Normalized Ratio (INR) devices (agents) and managers (e.g. cell phones, personal computers,
personal health appliances, and set top boxes) is established in this sta ndard in a manner that
enables plug-and-play interoperability. Work done in other IS O/IEEE 11073 standards is
leveraged, including existing terminology, information profiles, application profile standards, and
transport standards. T he use of specific term codes, formats, and behaviors in tele health
environments restricting optionality in base frameworks in favor of interoperability is specified. A
common core of functionality of INR devices is defined in this standard. In the context of personal
health devices, the measurement of the prothrombin time (PT) that is used to assess the lev el of
anticoagulant therapy and its presentation as the International Normalized Ratio compared to the
prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR
monitor include the management of the therapeutic level of anticoagulant used in the treatment of
a variety of conditions. The data modeling and its transport shim layer according to ISO/IE EE
11073-20601:2010 are provided by this standard, and the measurement method is not specified.
Keywords: IEEE 11073-10418, International Normalized Ratio (INR) monitor, medical device
communication, personal health devices
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
Copyright © 2011 by the Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 9 November 2011. Printed in the United States of America.
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Incorporated.
PDF: ISBN 978-0-7381-6704-6 STD97137
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---------------------- Page: 14 ----------------------

SIST EN ISO 11073-10418:2014
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
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SIST EN ISO 11073-10418:2014
Introduction
This introduction is not part of IEEE Std 11073-10418-2011, Health informatics—Personal health device
communication—Part 10418: Device specialization—International Normalized Ratio (INR) monitor.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
systems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this
standard establishes a normative definition of the communication between medication monitoring devices
and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a
manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards
including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes,
formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of
interoperability. This standard defines a common core of communication functionality for personal
telehealth INR devices. In this context, the measurement of the prothrombin time (PT) that is used to assess
the level of anticoagulant therapy and its presentation as the International Normalized Ratio (INR)
compared with the PT of normal blood plasma is referred to in INR monitoring. Applications of the INR
monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety
of conditions.
Notice to users
Laws and regulations
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provisions of this standard does not imply compliance to any applicable regulatory requirements.
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iv
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SIST EN ISO 11073-10418:2014
Errata
Errata, if any, for this and all other standards can be accessed at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
Interpretations
Current interpretations can be accessed at the following URL:
http://standards.ieee.org/findstds/interps/index.html.
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 with respect to the existence
or validity of any patent rights in connection therewith. 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
Copyright © 2011 IEEE. All rights reserved.
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SIST EN ISO 11073-10418:2014
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 2
1.3 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations .
...