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EN ISO 11073-10418:2014

(Main)

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)

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)

ISO/IEEE 11073-10418:2013 establishes 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. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards and transport standards. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of functionality of INR devices is defined in ISO/IEEE 11073-10418:2013. In the context of personal health devices, 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 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/IEEE 11073-20601:2010 are provided by ISO/IEEE 11073:10418:2013, and the measurement method is not specified.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10418: Gerätespezifikation - Monitor für den international standardisierter Thromboplastinzeit-Quotient (INR) (ISO/IEEE 11073-10418:2014, korrigierte Fassung 2014-05-01)

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 10418: Spécialisation des dispositifs - Surveillance du rapport normalisé international (INR) (ISO/IEEE 11073-10418:2014, Version corrigée 2014-05-01)

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
04-Mar-2014
Withdrawal Date
29-Sep-2014
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Drafting Committee
CEN/TC 251/WG 2 - Terminology and knowledge representation
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
05-Mar-2014
Due Date
02-Apr-2014
Completion Date
05-Mar-2014
Ref Project
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)

Relations

Corrected By
EN ISO 11073-10418:2014/AC:2016 - 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

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 11073-10418:2014

---------------------- Page: 2 ----------------------
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.

---------------------- Page: 3 ----------------------
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
...

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

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

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 Euro
...

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CEN
CEN ISO/TS 17251:2023(Main)
Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023)
SIST-TS CEN ISO/TS 17251:2023

This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.

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CEN
EN ISO/IEEE 11073-10408:2022(Main)
Health informatics - Device interoperability - Part 10408: Personal health device communication - Device specialization - Thermometer (ISO/IEEE 11073-10408:2022)
SIST EN ISO/IEEE 11073-10408:2023

Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth thermometer devices and compute engines (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, information models, 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 document defines a common core of communication functionality for personal telehealth thermometer devices.

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