Standard No.:	YY/T 1613-2018
English Name:	Requirements for process characterization and control in radiation sterilization of medical devices
Chinese Name:	医疗器械辐照灭菌过程特征及控制要求
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
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2018-09-28
Implemented on:	2019-10-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	20500 words
Translation Price(USD):	610.0
Delivery:	via email in 1~5 business day

本标准规定了医疗器械辐照灭菌过程特征及控制要求，对建立并满足GB 18280.1-2015中γ、电子束和X射线辐照装置的安装鉴定、运行鉴定、性能鉴定以及常规控制提出具体要求。
本标准适用于医疗器械产品的辐照灭菌过程。