SIST EN ISO 11073-10418:2014/AC:2017
(Corrigendum)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)
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)
ISO corr
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10418: Gerätespezifikation - Monitor für den international standardisierter Thromboplastinzeit-Quotient (INR) - Berichtigung 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10418: Spécialisation des dispositifs - Surveillance du rapport normalisé international (INR) - Rectificatif technique 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10418. del: Specialne naprave - Monitor za mednarodno umerjeno razmerje (INR) - Tehnični popravek 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10418: Gerätespezifikation - Monitor für den international standardisierter Thromboplastinzeit-Quotient (INR) - Berichtigung 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10418: Spécialisation des dispositifs - Surveillance du rapport normalisé international (INR) - Rectificatif technique 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)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)35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technology11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN ISO 11073-10418:2014/AC:2016SIST EN ISO 11073-10418:2014/AC:2017en,fr,de01-maj-2017SIST EN ISO 11073-10418:2014/AC:2017SLOVENSKI
STANDARD
SIST EN ISO 11073-10418:2014/AC:2017
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 11073-10418
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Health informatics æ Personal health device communication æ Part
s r v s zã Device specialization æ Internatnitor æ Technical Corrigendum
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Informatique de santé æ Communication entre dispositifs de santé personnels æ Partie
s r v s zã Spécialisation des dispositifs æ Surveillance du rapport normalisé EEE
Medizinische Informatik æ Kommunikation von Geräten für die persönliche Gesundheit æTeil
s r v s zã Gerätespezifikation æ Monitor für den international standardisierter Berichtigung
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EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
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t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Tous droits d 5exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CENä Alle Rechte der Verwertungá gleich in welcher Form und in welchem Verfahrená sind weltweit den nationalen Mitgliedern von CEN vorbehaltenä Refä NoäãEN ISO
s s r y uæ s r v s zã t r s x ESIST EN ISO 11073-10418:2014/AC:2017
EN ISO 11073-10418:2014/AC:2016 (E) 2 Contents Page European foreword . 3 SIST EN ISO 11073-10418:2014/AC:2017
EN ISO 11073-10418:2014/AC:2016 (E) 3 European foreword The text of ISO/IEEE 11073-10418:2014/Cor 1:2016 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 11073-10418:2014/AC:2016 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Endorsement notice The text of ISO/IEEE 11073-10418:2014/Cor 1:2016 has been approved by CEN as EN ISO 11073-10418:2014/AC:2016 without any modification.
SIST EN ISO 11073-10418:2014/AC:2017
SIST EN ISO 11073-10418:2014/AC:2017
INTERNATIONAL STANDARD ISO/IEEE 11073-10418:2014 TECHNICAL CORRIGENDUM 1 Published 2016-10-01 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION •
• ORGANISATION INTERNATIONALE DE NORMALISATION INTERNATIONAL ELECTROTECHNICAL COMMISSION •
• COMMISSION ÉLECTROTECHNIQUE INTERNATIONALEHealth informatics — Personal health device communication Part 10418: Device specialization — International Normalized Ratio (INR) monitor TECHNICAL CORRIGENDUM 1 Informatique de santé — Communication entre dispositifs de santé personnels — Partie 10418: Spécialisation des dispositifs — Surveillance du rapport normalisé international (INR) RECTIFICATIF TECHNIQUE 1 Technical Corrigendum 1 to ISO/IEEE 11073-10418 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10418-2014/Cor 1:2015). 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. ICS
35.240.80 Ref. No. ISO/IEEE 11073-10418:2014/Cor.1:2016(E)©
2016, IEEE and The Open Group – All rights reserved Published in SwitzerlandSIST EN ISO 11073-10418:2014/AC:2017
SIST EN ISO 11073-10418:2014/AC:2017
IEEE Std 11073-10418™-2011/Cor 1-2015 (Corrigendum to IEEE Std 11073-10418-2014) Health informatics—Personal health device communication Part 10418: Device specialization—International Normalized Ratio (INR) monitor Corrigendum 1 Sponsor IEEE 11073™ Standards Committee of the IEEE Engineering in Medicine and Biology Society Approved 3 September 2015 IEEE-SA Standards Board ISO/IEEE 11073-10418:O014/Cor.1:O01SEE)© ISO 2016 – All rights reserved © IEEE 2015 – All rights reserved SIST EN ISO 11073-10418:2014/AC:2017
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 standard 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 behaviors in telehealth 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 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 IEEE Std 11073-20601™-2014 are provided by this standard, and the measurement method is not specified. This standard corrects errors that have been identified in the IEEE Std 11073-10418-2011 to make it easier to implement the standard in an interoperable fashion. Keywords: IEEE 11073™, IEEE 11073-10418™, IEEE 11073-20601™, ISO/IEEE 11073-10418, ISO/IEEE 11073-20601, 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 © 2015 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 27 October 2015. Printed in the United States of America. IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics
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