Standard Number: YY/T 1302.2-2015(YY/T1302.2-2015)
Chinese:环氧乙烷灭菌的物理和微生物性能要求 第2部分：微生物要求
English:Physical requirements and microbiological performance of ethylene oxide sterilization Part 2: Microbiological aspects
Effective Date:2016-01-01
ICS:11.080.01
Standard Applicability:This standard applies to the ethylene oxide sterilization process of medical devices and other related products or materials. This standard specifies the microbiological requirements of ethylene oxide sterilization, provides guidance for the development and control of process parameters of ethylene oxide sterilization for production enterprises, and also provides a theoretical basis for the quality control and supervision of the relevant production process.
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