Metrological assurance of biodevices: The new method of calibration of biochemical analyzers

Abstract

Medical diagnostics and therapy use an extensive amount of electronics, optoelectronics, and laser devices. For their reliable functioning, calibration is unavoidable. Biochemical analyzers, which work on principles of absorptional spectrophotometry, became most widely present in medical biochemical laboratories. Construction of these devices is such, that in most cases, it does not allow calibration by usual methods, using neutral density (ND) filters as standards. For this reason, it was necessary to create a solution that could be used as a mean of comparison or even as a standard solution for methods of calibration of biochemical analyzers. In this article, the metrological characterization of solutions that are developed is presented, and the measuring uncertainty (ISO 1993) of methods used for calibration is estimated. The method that is developed provides metrological traceability to the primary spectrophotometric standard. With this method, metrological assurance in the field of the spectrophotometry in medical laboratories is completed. Copyright © Taylor & Francis Group, LLC.