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目的:建立一次性输液器还原物质测定中不确定度的分析方法模型。方法:根据还原物质的计算公式,建立不确定度的数学模型,分别采用A类和B类不确定度的计算方法,对各分量进行量化,最后合成、扩展。结果:用该法计算出了一次性输液器还原物质测定中不确定度为±0.009mL。结论:本方法可用于一次性医疗器械还原物质测定中不确定度的分析,也可作为其它间接碘量滴定法测定中不确定度分析的参考。
OBJECTIVE: To establish an analytical method of uncertainty in the determination of reducing substances in disposable infusion sets. Methods: According to the calculation formulas of reducing substances, a mathematical model of uncertainty was established. The methods of calculating the uncertainties of A and B respectively were used to quantify the components and finally to synthesize and expand them. Results: Using this method, the uncertainty of the determination of reducing substances in disposable infusion set was ± 0.009 mL. Conclusion: This method can be used for the analysis of uncertainty in the determination of reducing substances for disposable medical devices, and can also serve as a reference for the analysis of uncertainty in the determination of other indirect iodometric titration methods.