Standard No.:	YY/T 1463-2016
English Name:	Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites
Chinese Name:	医疗器械灭菌确认选择微生物挑战和染菌部位的指南
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:	China Food and Drug Adminstration
Issued on:	2016-01-26
Implemented on:	2017-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	100.0
Delivery:	via email in 1~3 business day

本标准规定了灭菌确认过程中选择合适的微生物挑战、合适的染菌部位、染菌方法以及复苏染菌微生物的技术。
本标准适用于医疗器械制造商进行灭菌确认试验。
本标准不适用于常规的灭菌试验，不适用于医疗器械清洁效果确认或消毒确认中的微生物挑战或染菌过程。