顶空气相色谱法测定一次性使用无菌注射器中环氧乙烷残留量的测量不确定度评定

MEASUREMENT UNCERTAINTY OF EPOXY ETHANE IN STERILE HYPODERMIC SYRINGES FOR SINGLE USE BY HEADSPACE GAS CHROMATOGRAPHY

依据JJF1059-1999,对顶空气相色谱法测定一次性使用无菌注射器中环氧乙烷残留量的不确定度进行了系统分析,找出影响测量结果不确定度的主要因素。对各不确定度分量进行了评定和量化,计算了合成标准不确定度和扩展不确定度,一次性使用无菌注射器中环氧乙烷残留量的测定结果表示为:(2.28±0.26)μg/g,k=2。

According to JJF 1059 - 1999,the determination uncertainty of epoxy ethane in sterile hypodermic syringes for single use determined by spacehead gas chromatography were systematically analyzed, and the sources of the uncertainty were analyzed for whole measurement procedure. Every uncertainty component was evaluated and quantified. The combined standard uncertainty and the expanded uncertainty were expressed. The result of the measurement of epoxy ethane in sterile hypodermic syringes for single use was expressed as （2.28 ± 0.26） μg/g, k = 2.