中国和欧盟医用外科口罩细菌检测方法对回收率的影响

Effect of bacterial test methods on recovery rate of surgical masks in China and European Union

目的明确我国和欧盟医用外科口罩细菌检测方法回收率的差异。方法采用微生物回收的方法对中国《医用外科口罩(YY 0469—2011)》和欧盟《医用口罩要求和试验方法(EN 14683—2019)》中的检测方法回收率进行对比分析,并探索两种方法中最优方法的环节。结果EN 14683—2019检测方法回收率高达65.1%,高于YY 0469—2011标准近4倍;洗脱方式为机械振摇,洗脱效果不如手动振摇法(回收率为68.6%);EN 14683—2019的可接受标准严于YY 0469—2011的可接受标准。结论EN 14683—2019的洗脱液中含有表面活性成分(吐温20),提高了检测方法的回收率;YY 0469—2011方法中手动振摇的洗脱方式对微生物的洗脱效果要优于EN 14683—2019方法中的机械振摇法。

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.