提高手术单、手术衣和洁净服生物负载回收率的新方法  

A new method to improve the recovery rate of surgical drapes,gowns and clean air suits

作　　者：李翠 李秀婷 刘兴翠 张小涵 杨婧 王文庆 LI Cui;LI Xiu-ting;LIU Xing-cui;ZHANG Xiao-han;YANG Jing;WANG Wen-qing(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan 250101,China;Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices,National Medical Products Administration)

机构地区：[1]山东省医疗器械和药品包装检验研究院,山东济南250101 [2]国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室

出　　处：《中国消毒学杂志》2025年第2期90-92,共3页Chinese Journal of Disinfection

基　　金：国家市场监督管理总局科技计划(2021MK181)。

摘　　要：目的 研究一种高回收率的方法检测手术单、手术衣和洁净服的生物负载。方法 选用9种不同材质的产品进行试验,比较YY/T 0506.7-2014《病人、医护人员和器械用手术单、手术衣和洁净服第7部分:洁净度-微生物试验方法》和新方法的微生物回收率。结果 9种不同材质的产品,采用新方法微生物的洗脱回收率均在70%以上,是YY/T 0506.7-2014方法回收率的2倍以上,远远高于药典对于微生物回收率的要求(0.5~2倍);对新方法检测结果统计学分析,变异系数均<10%,表明该方法结果的数值之间的离散程度较小,方法稳定性较好。结论 新方法较YY/T 0506.7-2014更适合手术单、手术衣和洁净服生物负载的检测。Objective To develop a high recovery method to determine the bioburden of surgical drapes,gowns and clean air suits.Methods Nine different materials were chosen,and the microbial recovery rate of YY/T 0506.7-2014"Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment-Part 7:Test methods for determination of cleanliness-microbial"was compared with that of the new method.Results The elution recoveries of microorganisms of 9 different materials by the new method were all about 70%,two times higher than that of YY/T 0506.7-2014,far higher than the requirements of pharmacopoeia for microbial recovery(0.5-2).Statistical analysis of the detection results of the new method showed that the coefficient of variation was less than 10%,indacating that the dispersion degree between the results of the new method was small,and the stability was good.Conclusion Compared with YY/T 0506.7-2014,the new method is more suitable for the detection of bioburden of surgical drapes,gowns and clean air suits.

关 键 词：手术单 手术衣 洁净服 生物负载 回收率 

分 类 号：R187[医药卫生—流行病学]