Standard No.:	YY/T 1607-2018
English Name:	Radiation sterilization of medical device—Method of dose setting
Chinese Name:	医疗器械辐射灭菌剂量设定的方法
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:	2018-06-26
Implemented on:	2019-7-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	310.0
Delivery:	via email in 1~5 business day

本标准规定了GB 18280.2—2015中方法2A和2B的一种改进方法，能够减少确定最小剂量的增量剂量的组数，该最小剂量可以达到预期无菌保证水平。本标准适用于生物负载低或处于低辐射抗力，且证明与历史水平一致时的产品。不适用于生物负载未被评估的产品。