一次性使用无菌阴道扩张器中环氧乙烷残留量测定的影响因素考察
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摘要
目的考察扩张器中环氧乙烷残留量测定的影响因素。方法采用顶空气相色谱法测定扩张器中环氧乙烷残留量,从材质、碎片面积、拆开单包装放置时间和碎片水浸泡时间四个方面来考察对结果的影响。结果扩张器采用聚苯乙烯材质,更易吸附环氧乙烷;样品前处理时,碎片面积越小,环氧乙烷越容易析出,含量越高;将扩张器拆开单包装放置,在短时间内对环氧乙烷的析出影响不大,无变化规律;样品前处理时,室温下碎片在顶空瓶中水浸泡时间越长,环氧乙烷析出量越多,且影响较大。结论通过考察影响因素,可以在测定扩张器环氧乙烷残留量的过程中,尽量排除这些因素的干扰,达到准确测量的目的。
Objective To study the factors influencing the determination of residual ethylene oxide in vaginal dilators. Methods Ethylene oxide residues in dilators were determinated by headspace gas chromatography. The influence on the results was investigated from four aspects: material, area of debris, placement time after removing package and soaking time of debris in water. Results The dilators made of polystyrene adsorbed ethylene oxide easily. The smaller the debris area, the easier it was to precipitate ethylene oxide and the higher ethylene oxide content during sample pretreatment. Short placement time after removing package had little effect on the precipitation of ethylene oxide. At room temperature, the longer the debris was soaked in the water of the top bottle, the more ethylene oxide was precipitated with great effect. Conclusion By studying the influencing factors, we can eliminate the interference of these factors and achieve the purpose of accurate measurement in the process of determining ethylene oxide residues from dilators.
Objective To study the factors influencing the determination of residual ethylene oxide in vaginal dilators. Methods Ethylene oxide residues in dilators were determinated by headspace gas chromatography. The influence on the results was investigated from four aspects: material, area of debris, placement time after removing package and soaking time of debris in water. Results The dilators made of polystyrene adsorbed ethylene oxide easily. The smaller the debris area, the easier it was to precipitate ethylene oxide and the higher ethylene oxide content during sample pretreatment. Short placement time after removing package had little effect on the precipitation of ethylene oxide. At room temperature, the longer the debris was soaked in the water of the top bottle, the more ethylene oxide was precipitated with great effect. Conclusion By studying the influencing factors, we can eliminate the interference of these factors and achieve the purpose of accurate measurement in the process of determining ethylene oxide residues from dilators.
引文
[1]林静,张星星,吴茜茜.一次性使用无菌阴道扩张器(包括检查型和手术型)的研制[J].机电信息,2018,(27):125-127.
[2]徐小虎,秦黎,严晓洁.一次性使用无菌阴道扩张器物理性能检测分析[J].中国医疗器械信息,2017,(15):48-49.
[3]孙敬,陈彦丽,柴海荣,等.环氧乙烷在医疗器械消毒应用中质量分析[J].继续医学教育,2017,31(2):130-131.
[4]邓小文,兰丽丽,蒋小良,等.顶空-气相色谱法测定纸尿裤中环氧乙烷残留量[J].中华纸业,2017,38(12):25-27.
[5]YY 0336-2013,一次性使用无菌阴道扩张器[S].
[6]毛红,余元骏.2种色谱柱测定医用棉签不同取样部位环氧乙烷残留量的比较研究[J].中国药业,2016,25(12):71-74.
[7]陆旋,叶雅.气相色谱法测定动脉压迫止血器中环氧乙烷残留量的方法验证[J].浙江化工,2014,45(11):46-50.
[8]GB/T 14233.1-2018,医用输液、输血、注射器具检验方法第一部分:化学分析方法[S].
[9]李双,李竹,姜帆,等.浅析无菌医疗器械中环氧乙烷的残留问题[J].中国医疗器械信息,2016,(23):78-80.
[10]章赛春,陈秀萍,陈侠钰.医用敷料环氧乙烷残留量超标相关因素研究[J].中国消毒学杂志,2014,31(4):341-343.
[11]兰丽萍,黄虹,兰瑛,等.不同材质的医疗物品环氧乙烷灭菌后残留量监测分析[J].医疗卫生装备,2012,33(12):121-122.
[12]刘朝艳.201 6-2017年世界塑料工业进展(1)[J].塑料工业,2018,46(3):1-12.
[13]刘星,郑涤新,耿媛媛,等.一次性使用袋式输液器环氧乙烷残留量检测的取样部位探讨[J].中国医疗器械杂志,2014,38(1):68-70.
[14]李传秋,王磊,陈军.环氧乙烷灭菌效果及残留量的实验研究[J].食品与药品,2014,16(1):41-43.
[15]王燕慧,李闻涛,许文峰,等.国家医疗器械监督抽验一次性使用无菌阴道扩张器质量评估[J].医疗装备,2018,31(5):35-37.
[16]简永耀,王铁柱,杨建林,等.567例阴道扩张器不良事件分析[J].中国医疗器械杂志,2014,38(6):439-441.C
[2]徐小虎,秦黎,严晓洁.一次性使用无菌阴道扩张器物理性能检测分析[J].中国医疗器械信息,2017,(15):48-49.
[3]孙敬,陈彦丽,柴海荣,等.环氧乙烷在医疗器械消毒应用中质量分析[J].继续医学教育,2017,31(2):130-131.
[4]邓小文,兰丽丽,蒋小良,等.顶空-气相色谱法测定纸尿裤中环氧乙烷残留量[J].中华纸业,2017,38(12):25-27.
[5]YY 0336-2013,一次性使用无菌阴道扩张器[S].
[6]毛红,余元骏.2种色谱柱测定医用棉签不同取样部位环氧乙烷残留量的比较研究[J].中国药业,2016,25(12):71-74.
[7]陆旋,叶雅.气相色谱法测定动脉压迫止血器中环氧乙烷残留量的方法验证[J].浙江化工,2014,45(11):46-50.
[8]GB/T 14233.1-2018,医用输液、输血、注射器具检验方法第一部分:化学分析方法[S].
[9]李双,李竹,姜帆,等.浅析无菌医疗器械中环氧乙烷的残留问题[J].中国医疗器械信息,2016,(23):78-80.
[10]章赛春,陈秀萍,陈侠钰.医用敷料环氧乙烷残留量超标相关因素研究[J].中国消毒学杂志,2014,31(4):341-343.
[11]兰丽萍,黄虹,兰瑛,等.不同材质的医疗物品环氧乙烷灭菌后残留量监测分析[J].医疗卫生装备,2012,33(12):121-122.
[12]刘朝艳.201 6-2017年世界塑料工业进展(1)[J].塑料工业,2018,46(3):1-12.
[13]刘星,郑涤新,耿媛媛,等.一次性使用袋式输液器环氧乙烷残留量检测的取样部位探讨[J].中国医疗器械杂志,2014,38(1):68-70.
[14]李传秋,王磊,陈军.环氧乙烷灭菌效果及残留量的实验研究[J].食品与药品,2014,16(1):41-43.
[15]王燕慧,李闻涛,许文峰,等.国家医疗器械监督抽验一次性使用无菌阴道扩张器质量评估[J].医疗装备,2018,31(5):35-37.
[16]简永耀,王铁柱,杨建林,等.567例阴道扩张器不良事件分析[J].中国医疗器械杂志,2014,38(6):439-441.C