Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy

Freckmann, Guido; Schmid, Christina; Baumstark, Annette; Rutschmann, Malte; Haug, Cornelia; Heinemann, Lutz

doi:10.1177/1932296815580160

Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy

In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in …