Standard No.:	YY/T 0567.6-2011
English Name:	Aseptic processing of health care products—Part 6:Isolator systems
Chinese Name:	医疗保健产品的无菌加工 第6部分：隔离器系统
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:	China Food and Drug Administration
Issued on:	2011-12-31
Implemented on:	2013-6-1
Status:	superseded
Superseded by:	YY/T 0567.6-2022 Aseptic processing of health care products—Part 6:Isolator systems
Superseded on:	2024-3-1
Language:	English
File Format:	PDF
Word Count:	9000 words
Price(USD):	250.00
Delivery:	via email in 1~3 business day

YY/T0567的本部分规定了用于无菌加工过程的隔离器系统的要求,并对用于医疗产品无菌加工的隔离器系统提供了鉴定、消毒、确认、操作和控制指南。
本部分集中于维持无菌条件的隔离器系统的使用,并可能包括有害原材料的应用。
本部分并非取代或代替国家的管理要求,例如生产管理规范(GMPs)和/或部分属于国家或辖区的简略要求。