Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations

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 the...

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Detalhes bibliográficos
Publicado no:J Diabetes Sci Technol
Main Authors: Freckmann, Guido, Schmid, Christina, Baumstark, Annette, Rutschmann, Malte, Haug, Cornelia, Heinemann, Lutz
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2015
Assuntos:
Review Articles
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4525642/
https://ncbi.nlm.nih.gov/pubmed/25872965
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1932296815580160
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