Standards Development

Scope

This proposal has been suggested as a particular standard series within IEC 60601 that addresses the basic safety and essential performance of continuous glucose monitoring systems used in both professional healthcare facilities and home healthcare environments

Purpose

Continuous glucose monitoring automatically tracks blood glucose levels, also known as blood glucose, throughout the day and night, providing you with real-time glucose level readings and trends over time.

This can help us make more informed decisions throughout the day about how to balance your food, physical activity, and medications.
The CGM system utilizes a tiny sensor that is inserted under your skin, typically on your belly or arm, to measure your interstitial glucose level, which is the glucose found in the fluid between your cells.
For low/high glucose levels, based on the settings made by patients or healthcare CGMs also generate audible alarms providers, to alert the patients to hypo/hyperglycemic events.
The sensor tests your glucose levels every few minutes, and a transmitter wirelessly sends the information to a monitor.