Standard No.:	YY/T 1544-2017
English Name:	Ethylene oxide sterilization safety and effectiveness basic supply requirements
Chinese Name:	环氧乙烷灭菌安全性和有效性的基础保障要求
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 Administration
Issued on:	2017-05-02
Implemented on:	2018-4-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	220.0
Delivery:	via email in 1~3 business day

本标准规定了环氧乙烷灭菌系统的质量管理体系、管理职责、人员要求、基础设施、工作环境、环氧乙烷灭菌系统的设计、环境监测等要求。
本标准适用于环氧乙烷灭菌，为环氧乙烷灭菌安全有效提供基础保障。
本标准不适用于规范环氧乙烷灭菌器性能、使用以及环氧乙烷灭菌工艺要求。