Clinically proven according to the requirements of the ISO
15197:2013 & EN ISO 15197:2015.
FORA strives for continued excellence in clinical competency and our priority is to ensure our solutions meet the emerging requirements for higher accuracy in blood glucose measurement including the latest ISO 15197:2013.
All ForaCare’s blood glucose and blood pressure monitoring systems are clinically validated. A symbol placed next to the product indicates the validation protocol and the researcher who participated in the study.
Clinically proven according to the requirements of the ISO
15197:2013 & EN ISO 15197:2015.
Clinically validated at ForaCare facilities, according to current ISO guidelines and requirements.
Reference | ISO 15197:2013 | EN ISO 15197:2015 |
---|---|---|
Organization/Publisher | International Organization for Standardization (ISO) | European Committee for Standardization |
Measurement Tolerance of < 100 mg/dL (5.55mmol/L) | + - 15 mg/dL | + - 15mg/dL |
Measurement Tolerance of ≥ 100 mg/dL (5.55mmol/L) | + - 15% | + - 15% |
Consensus Error Grid | 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. |