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辐照灭菌对医用一次性防护服材料性能的影响 被引量:1

Influences of Irradiation Sterilization on Material Properties of Medical Disposable Protective Clothing
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摘要 目的为应对新型冠状病毒肺炎疫情造成的医用一次性防护服严重短缺,缓解传统环氧乙烷灭菌技术无法满足防护服供应的情况,我国临时采用辐照灭菌代替环氧乙烷灭菌,从而大大缩短了灭菌时间,满足了医用一次性防护服的供应需求。但经辐照灭菌后,防护服的材料性能是否受到影响,仍需进一步研究。方法该研究比较了医用一次性防护服辐照灭菌前后的断裂强力,研究了不同辐照剂量对医用一次性防护服物理性能(抗渗水性、透湿量、抗合成血液穿透性、表面抗湿性、断裂强力、断裂伸长率、过滤效率、抗静电性)和灭菌效果的影响。结果与辐照灭菌前相比,辐照灭菌后医用一次性防护服的断裂强力下降了10 N左右;在4~25 kGy辐照剂量范围内,物理性能中的各项指标变化不大,均符合国家标准要求,随着辐照剂量的增加,带电量出现上升趋势,抗静电性降低,而断裂强力呈现略微下降的趋势,受辐照剂量影响较小;辐照剂量为12~25 kGy时,微生物指示物检测指标合格,灭菌效果较好。结论相较于传统的环氧乙烷灭菌方式,辐照灭菌具有快速高效的优势,但是受材料、成本等条件制约,要将辐照技术转化为医用一次性防护服等医用产品的常态化灭菌方式还面临很多挑战。 Objective In view of traditional ethylene oxide sterilization technology cannot meet the requirements for supply of protective clothing,and in order to cope with the serious shortage of medical disposable protective clothing caused by COVID-19 pandemic,the irradiation sterilization technology is temporarily adopted in China instead of ethylene oxide sterilization,which greatly reduces the sterilization time and meets the demand of medical disposable protective clothing.However,further research is needed to determine whether the material performance of protective clothing is affected after irradiation sterilization.Methods This study compared the breaking strength of medical disposable protective clothing before and after irradiation sterilization.and studied the influences of different radiation doses on physical properties(liquid barrier property,water vapour transmission rate,penetration resistance of synthetic blood,resistance to surface wetting,breaking strength,breaking elongation,filtrating efficiency,antistatic property)and sterilization effect of medical disposable protective clothing.Results The experimental results showed that the breaking strength of medical disposable protective clothing decreased by about 10 N after irradiation sterilization compared with before sterilization.Within the radiation dose range of 4~25 kGy,all the indexes of physical properties did not change obviously and could meet the requirements of national standards.With the increase of irradiation dose,the amount of charge appeared an increasing trend,the antistatic property decreased,but the breaking strength showed a slightly decreasing trend,and were less affected by radiation dose.When the radiation dose was 12~25 kGy,the microbial indicators were qualified and the sterilization effect was good.Conclusion Compared with the traditional ethylene oxide sterilization technology,the irradiation sterilization technology is more fast and efficient,but limited by materials and costs,it face a wide range of challenges to transfer the irradiation sterilization technology into a normal sterilization method for sterilizing medical products such as medical disposal protective clothing.
作者 陈明 付钊 冯毅 高晋梅 张发勇 郭亚秋 魏晓翠 马宁 李岱岳 Chen Ming;Fu Zhao;Feng Yi;Gao Jinmei;Zhang Fayong;Guo Yaqiu;Wei Xiaocui;Ma Ning;Li Daiyue(Hebei Institute for Drug and Medical Device Control,Shijiazhuang Hebei 050024,China;College of Biological Science and Engineering,Hebei University of Science and Technology,Shijiazhuang Hebei 050018,China;Hebei Pharmaceutical Professional Inspector Corps,Shijiazhuang Hebei 050024,China;Center for Drug Evaluation,Hebei,Shijiazhuang Hebei 050024,China)
出处 《医疗装备》 2021年第20期4-7,10,共5页 Medical Equipment
基金 河北省市场监督管理局科研计划项目(2020FY08) 河北省科技厅重点研发项目(20277728D)。
关键词 辐照灭菌 医用一次性防护服 断裂强力 灭菌效果 Irradiation sterilization Medical disposable protective clothing Breaking strength Sterilization effect
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