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ISO/IEEE 11073 Health Informatics - standards and related ISO standards for medical devices


It is recommended that ISO/IEEE 11073 health informatics standards and related ISO standards for medical devices to be followed as appropriate whenever any personal healthcare/medical device is interfaced with the EMR system for the purpose of clinical data exchange, retrieval, storage, etc.


Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard describes the landscape of transport-independent applications and information profiles for personal telehealth devices.

These profiles define data exchange, data representation, and terminology, for communication between personal health devices and compute engines, such as health appliances, set-top boxes, cell phones, and personal computers. This standard provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage.

ISO/IEEE 11073 health informatics standards and related ISO standards for medical devices consist of the following parts, under the general title Health Informatics-Personal health device communication (text in parentheses gives a variant of the subtitle):

Part Title
Part 10101 (Point-of-care medical device communication) Nomenclature
Part 10201 (Point-of-care medical device communication) Domain information model
Part 10404 Device specialization - Pulse oximeter
Part 10407 Device specialization - Blood pressure monitor
Part 10408 Device specialization - Thermometer
Part 10415 Device specialization - Weighing scale
Part 10417 Device specialization - Glucose meter
Part 10420 Device specialization - Body composition analyser
Part 10421 Device specialization - Peak expiratory flow monitor (peak flow)
Part 10471 Device specialization - Independent living activity hub
Part 10472 Device specialization - Medication monitor
Part 20101 (Point-of-care medical device communication) Application profiles - Base standard
Part 20601 Application profile - Optimized exchange protocol
Part 30200 (Point-of-care medical device communication) Transport profile - Cable connected
Part 30300 (Point-of-care medical device communication) Transport profile - Infrared wireless
Part 30400 (Point-of-care medical device communication) Interface profile - Cabled Ethernet
Part 90101 (Point-of-care medical device communication) Analytical instruments - Point-of-care test
Part 91064 (Standard communication protocol) Computer-assisted electrocardiography
Part 92001 (Medical waveform format) - Encoding rules

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