Standard Number: YY/T 0681.10-2011(YY/T0681.10-2011)
Chinese:无菌医疗器械包装试验方法 第10部分：透气包装材料微生物屏障分等试验
English:Test methods for sterile medical device package-Part 10:Test for microbial barrier ranking of porous package material
Effective Date:2013-06-01
ICS:11.080.040
Standard Applicability:YY/T 0681 This part specifies a test method for determining the penetration of airborne bacteria into breathable materials used for the packaging of sterile medical devices. The test method is designed to test the material under conditions where the bacterial spores are able to penetrate the test material in order to facilitate grading of the material. This test method requires the manipulation of microorganisms and should only be performed by trained personnel. NOTE: Information on precision and bias for this test method is provided in Appendix B.
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