BS EN ISO 11073-10425:2019

What is ISO 11073-10425 ‒ Continuous glucose monitor about?  

ISO 11073-10425 is a part of a multi-series standard that covers medical devices in health informatics. 

ISO 11073-10425 establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards.  

ISO 11073-10425 specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. It defines a common core of communication functionality of CGM devices.  

Note: In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person. 

Who is ISO 11073-10425 ‒ Continuous glucose monitor for? 

ISO 11073-10425 on continuous glucose monitor is useful for: 

• Manufacturers and designers of Glucose monitor devices 
• Suppliers and dealers of  Glucose monitor devices 
• Hospitals/health care companies 
• Companies manufacturing medical devices 

Why should you use ISO 11073-10425 ‒ Continuous glucose monitor? 

ISO 11073 series of standards enable communication between medical devices and external computer systems. These standards align with and draw on, the existing clinically focused standards to provide support for communication of data from clinical or personal health devices (PHDs). 

ISO 11073-10425 creates an optimized framework for you and describes a specific, interoperable communication approach for continuous glucose monitors (CGMs). It gives you the definition of the communication between continuous glucose monitor (CGM) devices and managers like cell phones, personal computers, personal health appliances, set-top boxes.  

ISO 11073-10425 leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability.  

ISO 11073-10425 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices (PHDs) and compute engines. It focuses mainly on interoperability, as it 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. 

What’s changed since the last update?  

BS EN ISO 11073-10425:2019 supersedes EN ISO 11073-10425:2016, which has been technically revised.