DIN EN ISO 11073-10406:2013-04

The ISO/IEEE 11073 family of standards enables 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 and private environment. The primary objectives are: - provision of "plug-and-play" functionality and interoperability with medical devices for real-time applications which are associated with patients or which are person-related. - 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 health-related device communication, this standard specifies a normative definition of the communication between personal basic electrocardiograph (ECG) devices and compute engines (for example, 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, in particular ISO/IEEE 11073 standards on terminology, and Part 20601 of this series on information models. Interoperability is the key to growing the potential market for these devices and to enabling people to be better informed participants in the management of their health. This standard specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This standard defines common core functions for communication of personal telehealth basic ECG (1- to 3-lead ECG) devices. In this context these monitoring ECG devices are generally used as ECG devices monitoring the electrical activity of the heart over a longer period of time. These monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to: - including support for wearable ECG devices; - limiting the number of leads supported by the equipment to three; - not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. Furthermore determinations of the heart rate and respiration rate, based on deviated ECG characteristics, are part of the Scope, but these are optional physiological measurements. The committee responsible for this standard is NA 063-07-02 AA "Interoperabilität" ("Interoperability") at DIN.