ISO 15197:2013 Accuracy Standards Evolution

Introduction

The ISO 15197:2013 standard sets the benchmark for blood glucose monitoring systems. It covers diabetic test strips too.

History and Development

Introduced in 2003, the standard has seen significant updates. The 2013 version is a major milestone.

Key Provisions

The standard demands accuracy: at least 95% of results must fall within ±15% of the reference value for glucose concentrations > 100 mg/dL. For concentrations ≤ 100 mg/dL, results must be within ±15 mg/dL.

Impact on Manufacturers

Major manufacturers like Roche and Abbott have adapted their products to meet these requirements.

Conclusion

The ISO 15197 standard evolves, driving the industry to improve blood glucose monitoring accuracy. This means better outcomes for diabetic patients.