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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

姜晨阳 刘书畅

中国标准化Issue(10):172-175,4.
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

姜晨阳 1刘书畅1

作者信息

  • 1. 威海市食品药品检验检测研究院
  • 折叠

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.

中国标准化

1002-5944

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