ISO/IEEE 11073-10418:2014 PDF
Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 60
- Дата публикации:
- 13 февраля 2014 г.
- Издание:
- ISO/IEEE IS 11073 edition 1 version 1
- ICS:
- 35.240.80
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.
Abstract
Overview
ISO/IEEE 11073-10418:2014 defines a device specialization for International Normalized Ratio (INR) personal health devices within the ISO/IEEE 11073 family. It provides a normative definition for communication between INR agents (personal INR monitors) and managers (smartphones, PCs, personal health appliances, set-top boxes) to enable plug-and-play medical device interoperability in telehealth environments. The standard leverages common ISO/IEEE 11073 terminology, information profiles and transport rules, and specifies term codes, formats and behaviors to reduce optionality and improve interoperability. The document defines a common core of INR device functionality; it models INR/PT measurement data and uses the transport shim of ISO/IEEE 11073-20601. The standard does not specify the measurement method itself.
Key topics and technical requirements
- Plug-and-play interoperability: Defines communication patterns so INR devices can interoperate with managers and health platforms without custom integration.
- Data modeling: Uses ISO/IEEE 11073 information models and specific term codes to represent prothrombin time (PT) and International Normalized Ratio (INR) values consistently.
- Transport shim: Specifies mapping to the ISO/IEEE 11073-20601 optimized exchange protocol for reliable data transport between agent and manager.
- Restricted optionality: Narrows base-framework choices (codes, formats, behaviours) to reduce ambiguity and improve cross-vendor compatibility.
- Core functionality: Establishes a baseline set of device capabilities and attributes required for personal INR monitors (data items, event reporting, units).
- Regulatory note: Compliance with this standard does not guarantee regulatory approval; implementers must consult applicable laws and medical-device regulations.
Applications and users
- Device manufacturers building personal INR monitors seeking standardised communication interfaces and interoperability.
- Firmware and embedded systems engineers implementing ISO/IEEE 11073 device agents and data models.
- Mobile and telehealth application developers integrating INR device data into patient apps, EHRs, or remote monitoring platforms.
- Healthcare IT integrators and system architects designing plug-and-play telehealth solutions.
- QA, regulatory and product teams using the standard as a specification reference for device communication and interoperability testing.
Related standards
- ISO/IEEE 11073-20601 - Application profile: optimized exchange protocol (transport shim)
- ISO/IEEE 11073-10101 - Nomenclature (term codes)
- ISO/IEEE 11073-10201 - Domain information model
- Other 11073 device specializations (e.g., 10407 Blood Pressure, 10417 Glucose Meter) for broader personal health device ecosystems
Keywords: ISO/IEEE 11073-10418, INR monitor, personal health device communication, medical device interoperability, prothrombin time, INR monitoring, telehealth, plug-and-play, ISO/IEEE 11073-20601.
Технические детали
- Технический комитет
- ISO/TC 215 - Health informatics
- SKU
- ISO/IEEE 11073-10418:2014
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