一次性医疗器械还原物质实验中不确定度的分析___
Analysis on uncertainty in test of reducing substances of disposable infusion sets
分类号：
出版年·卷·期（页码）：2009,29 (7):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的：建立一次性医疗器械还原物质实验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，然后根据数学模型，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医疗器械还原物质实验中不确定度为±0.009mL。结论：本方法思路清晰，简便可行，可用于一次性医疗器械还原物质实验中不确定度的分析，也可作为其它间接碘量滴定法实验中不确定度分析的参考。
-----英文摘要：---------------------------------------------------------------------------------------
Abstract Objective: A method model was established for analysis on uncertainty in test of reducing substances of disposable medical device. Method: An uncertainty mathematical model was established according to the formula of reducing substances. Then, every fraction was quantitative analyzed by the method of uncertainty A or uncertainty B. Finally, uncertainty was compounded and extended. Results: Uncertainty in test of reducing substances of disposable medical device has been computed. It is ±0.009mL. Conclusion: The method is simple and has clear reasoning ,good stability, which can be used for analysis on uncertainty in test of reducing substances of disposable medical device, and can also be a reference to analysis on uncertainty in other test of indirect iodimetry.
-----参考文献：---------------------------------------------------------------------------------------
1 The EURACHEM Working Group on Uncertainty in Chemical Measurement, Quantifying Uncertainty in Analytical Measurement, 1995. 21
2 Infusion equipment for medical use-Part 4: Infusion sets for single use, gravity feed, MOD. ISO8536. 2004.6
3 ISO Standards Handbook 3: Statistical Methods. 1981.30
4 Taylor, J. K. Handbook for SRM Users. NBS Spec. Publ. 1985. 260
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