| IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM) |
| Recognition Date | 2015-01-27 |
| Recognition List | 038 |
| Recognition Number | 13-72 |
| Extent | Complete standard |
| Standards Orgs | IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/ |
| STG | Software/Informatics |
| FDA Tech | Naomi R Schwartz FDA/OMPT/CDRH/OIR/DCTD/DDDB/ 301-796-2645 naomi.schwartz@fda.hhs.gov |
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This standard 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. 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 of CGM devices. 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.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Sensor, Glucose, Invasive | Class 3 | MDS |
| There is no relevant guidance developed at this time. |