DIN EN ISO 11073-10418:2014-06

The ISO/IEEE 11073 family of standards enables communication between medical devices and external computer systems. It allows for automated detailed acquisition of personal vital data and functional parameters by using monitoring devices and therapy equipment, for example at an intensive care unit or in an operating theatre but also within domestic or private environment. The primary objectives are: - providing plug-and-play functionality and interoperability with patient-connected or personal medical devices for real-time applications; - simplification of the efficient interchange of measured vital data, relevant context information as well as operating data of the medical devices used. Here, "real time" means that data from several different medical devices, if appropriate, can be captured on time and can be represented and processed within fractions of seconds. "Plug-and-play" means that users only have to establish the communication link to a device. Its recognition by the system, the configuration of communication parameters and, if applicable, application and finally the initiation of data transmission take place automatically which 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 communication between personal telehealth International Normalized Ratio (INR) devices (agents) and compute engines (such as 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 especially ISO/IEEE 11073 standards for terminology, information models, application profile standards, and data transport standards. The standard specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting ambiguity in base frameworks in favour of interoperability. This standard defines a common core of communication functionality for personal telehealth INR devices. In this context, 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 (INR) compared with 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. This standard provides the data modelling and its transport shim layer according to DIN EN ISO 11073-20601:2011 and does not specify the measurement method. This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and compute engines (such as cell phones, personal computers, personal health appliances, and set top boxes). 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. The responsible committee is NA 063-07-02 AA "Interoperabilität" ("Interoperability") at DIN.