Standard No.:	YY 1277-2016
English Name:	Steam sterilizer―Performance requirements of biosafety
Chinese Name:	蒸汽灭菌器生物安全性能要求
Chinese Classification:	C47    Public medical equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.080.10 11.080.10    Sterilizing equipment 11.080.10
Issued by:	China Food and Drug Adminstration
Issued on:	2016-03-23
Implemented on:	2018-1-1
Status:	to be superseded
Superseded by:	YY 1277-2023 Steam sterilizer-Performance requirements for biosafety
Superseded on:	2026-9-15
Language:	English
File Format:	PDF
Word Count:	7500 words
Price(USD):	220.0
Delivery:	via email in 1~3 business day

本标准适用于以生物安全为目的的材料、器械、器皿、培养基以及废弃物等物品的灭菌，以防止通过气溶胶等方式传播的致病因子对人员、动植物或环境造成污染。
本标准规定了蒸汽灭菌器生物安全性能要求的术语和定义、要求和试验方法等内容。
本标准不适用密闭性液体的灭菌。