Standard No.:	YY/T 1302.2-2015
English Name:	Physical requirements and microbiological performance of ethylene oxide sterilization―Part 2:Microbiological aspects
Chinese Name:	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
Chinese Classification:	47
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2015-03-02
Implemented on:	2016-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	140.0
Delivery:	via email in 1~5 business day

本标准规定了环氧乙烷灭菌微生物方面的相关要求，为生产企业对环氧乙烷灭菌的过程参数的开发与控制提供了指导，也为相关生产过程的质量控制和监管工作提供了理论依据。
本标准适用于医疗器械及其它相关产品或材料的环氧乙烷灭菌过程。