ISO 15197:2013 Accuracy Standards
The International Organization for Standardization (ISO) sets the benchmark. It published ISO 15197:2013 in 2013. This standard outlines the requirements for blood glucose monitors and test strips.
Key Points:
- It defines acceptable error margins for blood glucose measurements.
- It specifies minimum requirements for system accuracy and precision.
- It applies to all blood glucose monitoring systems, including test strips.
ISO 15197:2013 ensures blood glucose monitors and test strips meet strict accuracy criteria. This gives users reliable results. Manufacturers must adhere to these standards to guarantee product quality.