中国标准化Issue(10):172-175,4.DOI:10.3969/j.issn.1002-5944.2025.10.030
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
Uncertainty Evaluation of Detection of Ethylene-oxide Content in Absorbable Surgical Sutures
摘要
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 4.420 mg/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.关键词
可吸收性外科缝线/环氧乙烷/不确定度Key words
absorbable surgical sutures/ethylene-oxide/uncertainty引用本文复制引用
姜晨阳,刘书畅..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[J].中国标准化,2025,(10):172-175,4.