Standard No.:	YY/T 1268-2023
English Name:	Product adoption and process equivalence for ethylene oxide sterilization
Chinese Name:	环氧乙烷灭菌的产品追加和过程等效
Chinese Classification:	C47    Public medical equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Issued by:	National Medical Products Adminstration
Issued on:	2023-03-14
Implemented on:	2024-5-1
Status:	valid
Superseding:	YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization
Language:	English
File Format:	PDF
Word Count:	7500 words
Price(USD):	225.00
Delivery:	via email in 1~3 business day

本文件规定了医疗器械环氧乙烷灭菌过程中新产品或变更的产品追加到已经确认的灭菌过程的要求，并为使用不同灭菌设备时评估灭菌过程等效性提供方法。
本文件适用于经环氧乙烷灭菌处理、采用传统放行或参数放行的医疗器械。
本文件适用的医疗器械环氧乙烷灭菌情况包括：a) 在已经确认的环氧乙烷灭菌过程中增加新产品；
b) 评估已确认产品的变更；
c) 已确认的过程转移到不同的场地或设备；
d) 评估灭菌过程的等效性。