The evolution of ISO 15197 represents a critical tightening of safety and accuracy benchmarks for blood glucose monitoring systems. The original ISO 15197:2003 standard allowed for a ±20% margin of error for glucose levels ≥75 mg/dL. Recognizing that this variance was too high for precise insulin management, the standard was revised to ISO 15197:2013.

The 2013 standard narrowed the acceptable margin of error to ±15% for glucose levels ≥100 mg/dL and ±15 mg/dL for levels below that threshold. Beyond simple accuracy, the 2013 revision mandated rigorous testing for hematocrit influence and interfering substances (such as maltose and acetaminophen), and required validation of lay user performance. This regulatory shift forced manufacturers to abandon older enzyme chemistries (like GDH-PQQ) and adopt multi-electrode strip architectures with advanced signal processing to ensure compliance.