Effect of bacterial test methods on recovery rate of surgical masks in China and European Union
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1.Microbe Inspection Department, Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, Jinan 250101, China;2.Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices, National Medical Products Administration, Jinan 250101, China;3.Business Department, Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, Jinan 250101, China

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R185

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    Abstract:

    Objective To clarify the difference in the recovery rate of bacterial test methods of surgical masks between China and the European Union (EU). Methods The recovery rate of test methods in Medical face masks (YY 0469-2011) issued by China and Medical face masks-Requirements and test methods (EN 14683-2019) was compared, the best link of the two methods was explored. Results The recovery rate of EN 14683-2019 test method was as high as 65.1%, which was nearly 4 times higher than that of YY 0469-2011 criteria; the elution method was mechanical shaking, and the elution effect was not as good as manual shaking (recovery rate was 68.6%); the acceptable criteria of EN 14683-2019 was stricter than that of YY 0469-2011. Conclusion The eluent of EN 14683-2019 contains surfactant (Tween 20), which improves the recovery rate of the test method; the elution effect of manual shaking in YY 0469-2011 method is better than that of mechanical shaking in EN 14683-2019 method.

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王文庆,李翠,马恒,等.中国和欧盟医用外科口罩细菌检测方法对回收率的影响[J].中国感染控制杂志英文版,2022,(3):256-260. DOI:10.12138/j. issn.1671-9638.20221894.
Wen-qing WANG, Cui LI, Heng MA, et al. Effect of bacterial test methods on recovery rate of surgical masks in China and European Union[J]. Chin J Infect Control, 2022,(3):256-260. DOI:10.12138/j. issn.1671-9638.20221894.

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History
  • Received:September 13,2021
  • Revised:
  • Adopted:
  • Online: April 28,2024
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