DIN EN ISO 11073-10424
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep apnoea breathing therapy equipment (SABTE) (ISO/IEEE 11073-10424:2016); English version EN ISO 11073-10424:2016
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10424: Gerätespezifikation - Schlafapnoe-Atemtherapiegeräte (ISO/IEEE 11073-10424:2016); Englische Fassung EN ISO 11073-10424:2016
Overview
The ISO/IEEE 11073 family of standards enables the data transfer between medical devices and computer systems. It allows for automated, detailed recording of personal vital data and functional parameters by using monitoring and therapy devices - for example, in an intensive care unit or in the operating theatre, but also in the domestic or private environment. The primary objectives are: - provision of "plug-and-play" functionality and interoperability of patient-connected or personal medical devices for real-time applications. - simplification of the efficient exchange of measured vital data, relevant contextual information, and operational data of the medical devices used. "Real-time" means that data from several different medical devices, if appropriate, are recorded exactly on time and can be plotted or processed in fractions of seconds. "Plug-and-play" means that users only have to establish the communication link to a device. Its recognition, configuration of communication parameters and application, if applicable, and finally, the beginning of the data transfer are automatically achieved by the system, that means, without human intervention. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment and managers (such as cell phones, personal computers, personal health appliances, 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 standard defines a common core of communication functionality for sleep apnoea breathing therapy equipment. In this context, sleep apnoea breathing therapy equipment are defined as devices that are intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment are primarily used in the home health-care environment by a lay operator without direct professional supervision. This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices (agents) and managers (such as cell phones, personal computers, personal health appliances, and set top boxes). Interoperability is key to growing the potential market for these devices and to enabling people to be better informed participants in the management of their health. The committee responsible is NA 063-07-02 AA "Interoperabilität" (Interoperability) at DIN.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-02-02 AA - Interoperability
Responsible european committee
CEN/TC 251/WG 2 - Technology and Applications