Standard No.:	YY/T 1608-2018
English Name:	Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits
Chinese Name:	医疗器械辐射灭菌验证剂量实验和灭菌剂量审核的抽样方法
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
Issued by:	National Medical Products Adminstration
Issued on:	2018-06-26
Implemented on:	2019-7-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	10500 words
Price(USD):	230.00
Delivery:	via email in 1~5 business day

本标准规定了GB 18280.2—2015中灭菌剂量选择和审核的一种改进方法，该方法在确保产品达到预期无菌保证水平的同时，可以减少要求的产品单元数量，并阐述了验证剂量实验和灭菌剂量审核的抽样方案。本标准适用于GB 18280.2—2015中灭菌剂量选择和审核在确保产品达到预期无菌保证水平时的抽样。