可吸收性外科缝线中环氧乙烷残留量测定的不确定度评定

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Uncertainty Evaluation of Detection of Ethylene-oxide Content in Absorbable Surgical Sutures

JIANG Chen-yang LIU Shu-chang （Weihai Institute for Food and Drug Control）

Abstract： In order to improve the accuracy of the detection results of ethylene-oxide content in medical equipment， absorbable surgical suture is taken as an example， and the uncertainty is evaluated. The ethylene-oxide content in absorbable surgical sutures is tested according to GB/T 14233.1-2022， Test methods for infusion， transfusion， injection equipment for medical use—Part 1： Chemical analysis methods. The uncertainty is analyzed and evaluated. At the 95% confidence interval， the expanded uncertainty is 4.420mg/Kg ， and the range of tested results is （14.765±4.420）mg/Kg. and the established method can provide reference for the uncertainty evaluation of ethylene-oxide content testing in other medical equipment.

Keywords： absorbable surgical sutures， ethylene-oxide， uncertainty

0 引 言

环氧乙烷（EO）残留量测定项目是评定医疗器械产品是否安全有效的重要指标之一[1]。（剩余3509字）