process validation
process validation, Total:17 items.
The international standard classification for "process validation" includes: sterilized packaging , Sterilization and disinfection in general .
The Chinese standard classification for "process validation" includes: Public medical equipment , Medical apparatus and devices in general .
Professional Standard - Aviation
- HB 8413-2013 Procedures and Requirements for Special Process Validation
Professional Standard - Commodity Inspection
- SN/T 3062.1-2011 Packing Materials for Terminally Sterilized Medical Devices for Import. Part 1: Validation Requirements for Forming
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 19973.2-2025 Sterilization of health care products—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
- GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
- GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
- GB/T 19633.2-2015 Packaging for terminally sterilized medical devices―Part 2:Validation requirements for forming,sealing and assembly processes
Professional Standard - Medicine
- YY/T 0771.4-2015 Medical devices utilizing animal tissues and their derivatives―Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes
British Standards Institution (BSI)
- BS EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
- BS EN ISO 11607-1:2020+A11:2022 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
- BS EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
- BS EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
International Organization for Standardization (ISO)
- ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
European Committee for Standardization (CEN)
- EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
- EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming@ sealing and assembly processes
VN-TCVN
- TCVN 7394-2-2008 Packaging for terminally sterilized medical devices.Part 2: Validation requirements for forming, sealing and assembly processes
Korean Agency for Technology and Standards (KATS)
- KS P ISO 11607-2:2007 Packaging for terminally sterilized medical devices－Part 2：Validation requirements for forming, sealing and assembly processes
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