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Fresenius J Anal Chem ; 370(2-3): 183-8, 2001 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-11451233

RESUMO

The new version of ISO Guide 34 requires producers of certified reference materials (CRMs) to include contributions of possible instability to the overall CRM uncertainty, to obtain a value for the uncertainty in compliance with the Guide to the Expression of the Uncertainty in Measurement (GUM). A pragmatic approach to estimating the uncertainty of stability is presented. It relies on regression analysis of stability data with subsequent testing of the slope of the regression line for significance. If the slope is found to be statistically insignificant, a shelf life is chosen and the uncertainty connected with this time is estimated via the standard deviation of the slope. This uncertainty is included in the overall uncertainty of the CRM. This approach is explained with examples showing its applicability to matrix CRMs.


Assuntos
Técnicas de Química Analítica/normas , Padrões de Referência , Estabilidade de Medicamentos , Humanos , Hidrocortisona/sangue , Probabilidade , Reprodutibilidade dos Testes , Soroalbumina Bovina/química , gama-Glutamiltransferase/química
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