Standard Number: YY/T 0681.17-2019(YY/T0681.17-2019)
Chinese:无菌医疗器械包装试验方法 第17部分：透气包装材料气溶胶过滤法微生物屏障试验
English:Test methods for sterile medical device package-Part 17:Testing the microbial barrier performance of porous package materials using aerosol filtration method
Effective Date:2020-10-01
ICS:11.080.40
Standard Applicability:This standard specifies the determination of the aerosol filtration performance of breathable packaging materials by generating an aerosol of particles with a diameter of 1.0 μm, and evaluating the filtration efficiency of the material using two particle counters. This standard applies to the final sterilization of medical devices packaging with breathable materials. This standard does not apply to Bentham permeability more than 4000 mL / min of the material.
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