Standard No.:	GB/T 19973.2-2005
English Name:	Sterilization of medical devices. Microbiological methods. Part 2: Tests of sterility performed in the validation of a sterilization process
Chinese Name:	医疗器械的灭菌 微生物学方法 第2部分：确认灭菌过程的无菌试验
Chinese Classification:	C47    Public medical equipment
Professional Classification:	GB    National Standard
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Source Content Issued by:	AQSIQ; SAC
Issued on:	2005-11-04
Implemented on:	2006-4-1
Status:	superseded
Superseded by:	GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Superseded on:	2019-4-1
Abolished on:	2019-04-01
Target Language:	English
File Format:	PDF
Word Count:	6000 words
Translation Price(USD):	140.0
Delivery:	via email in 1~3 business day

GB/T 19973的本部分规定了医疗器械在经过低于所规定的灭菌剂量作用后，对其进行无菌试验的一般要求。这些试验适用于对灭菌过程的确认。本部分不适用于:a) 已经过灭菌的日常销售产品的无菌试验；b) 药典无菌试验；c) 生物指示物(包括接种的产品)的培养。