Terminally Sterilized Medical Devices
Terminally Sterilized Medical Devices, Total:11 items.
The international standard classification for "Terminally Sterilized Medical Devices" includes: Sterilization and disinfection , sterilized packaging , Sterilization and disinfection in general .
The Chinese standard classification for "Terminally Sterilized Medical Devices" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices .
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 19633-2005 Packaging for terminally sterilized medical devices
- GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
- GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
- GB/T 19633.2-2015 Packaging for terminally sterilized medical devices―Part 2:Validation requirements for forming,sealing and assembly processes
- GB/T 19633.1-2015 Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systems
Professional Standard - Medicine
- YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
- YY/T 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods
- YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
Group Standards of the People's Republic of China
- T/CAMDI 058-2020 Packaging for terminally sterilized medical devices—Guidance on the application of GB/T 19633.1 and GB/T 19633.2
Korean Agency for Technology and Standards (KATS)
- KS P ISO 11607-2007 Packaging for terminally sterilized medical devices
SCC
- AAMI 11607:1997 Packaging for terminally sterilized medical devices
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