气相色谱法测定非吸收性外科缝线中环氧乙烷残留量的不确定度分析

目的：对气相色谱法测定非吸收性外科缝线中环氧乙烷残留量的不确定度进行分析,以找出影响不确定度的因素。方法：建立气相色谱法测定非吸收性外科缝线中环氧乙烷残留量的数学模型,并根据《测量不确定度评定与表示》（JJF1059-1999）中有关规定,量化各不确定度分量,计算合成不确定度从而得出测定结果的扩展不确定度。结果：测定结果的合成不确定度为0.7μg·g^-1,扩展不确定度为1.4μg·g^-1,非吸收性外科缝线中环氧乙烷残留量为（27.5±1.4）μg·g^-1（k=2）。结论：测定结果的不确定度主要来源于拟合曲线的影响,故气相色谱仪的稳定性是测量准确与否的关键所在。建立的不确定度评估方法适用于气相色谱法测定非吸收性外科缝线中环氧乙烷残留量的不确定度分析。

Analysis of the Measurement Uncertainty in Determining the Residue of Ethylene Oxide in Non-absorbent Surgical Suture by Gas Chromatography

Objective：To analyze the measurement uncertainty in determining the residue of ethylene oxide in non-absorbent surgical suture by gas chromatography,and then to find out the influencing factors.Methods：The mathematical model of determining the residue of ethylene oxide in non-absorbent surgical suture by gas chromatography was established,and the uncertainty was appraised according to JJF1059-1999.Each component of uncertainty was quantified,and the evaluation results of measurement uncertainty were obtained.Results：The combined uncertainty was 0.7 μg ·g^-1,the expanded uncertainty was 1.4 μg ·g-1,and the residue of ethylene oxide was （27.5±1.4） μg ·g^-1 （k=2）.Conclusion：The uncertainty was originated primarily from the matched curve,so the stability of gas chromatography was the critical factor.The uncertainty assessment method established can be used for uncertainty analysis of determining the residue of ethylene oxide in non-absorbent surgical suture by gas chromatography.