ISO 15197

The performance standard for blood glucose monitoring systems. Under the 2013 edition, 95% of results must be within ±15 mg/dL (0.83 mmol/L) of the reference below 100 mg/dL (5.55 mmol/L) and within ±15% at or above it, and 99% must fall in the clinically acceptable zones of the consensus error grid. In hospitals, point-of-care meters sit under the laboratory's POCT governance, with control solutions and operator training.

A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.