Aseptic Process Validation
Aseptic Process Validation, Total:32 items.
The international standard classification for "Aseptic Process Validation" includes: Manufacturing forming processes , Dividing and tool-workpiece holding devices , General methods of tests and analysis for food products , Textile machinery , Aircraft and space vehicles in general , Tea .
The Chinese standard classification for "Aseptic Process Validation" includes: Technical management , Technical management , Processing technology in general , Technological equipment in general , Basic standards and general methods , Textile machinery and apparatus in general , Basic standards and general methods , Fertilizer and soil conditioner .
Professional Standard - Electron
- SJ/T 10532.13-1994 Technological management-Technological verification
Professional Standard - Machinery
- JB/T 9169.9-1998 Guide for technological management - Engineer verification
- JB/T 9167.5-1998 Management guide for tooling design Proof rule for tooling
Professional Standard - Geology
- DZ/T 0198.11-1997 Guideline for geological instrument process management - process verification
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 24736.4-2009 Management guide for tooling design—Part 4:Proof rule for tooling
- GB/T 18526.1-2001 Code of good irradiation practice for the control microflora in tea extract powder
- GB/T 24737.8-2009 Guide for technological management—Part 8:Process verification
- GB/T 18526.2-2001 Code of good irradiation practice for the control of microorganism in pollen
Group Standards of the People's Republic of China
- T/CAMMT 19-2019 The validation specification of trial production process on engine
- T/SHBX 006-2024 Single-use sterile connectors for pharmaceutical process
Professional Standard - Textile
- FZ/T 91003.9-1993 Guidance of textile machinery manufacturing process management - process verification
- FZ/T 91002.5-1993 Guidance of design and management of textile machinery process equipment - rules of design selection
Professional Standard - Aerospace
- QJ 2233-1992 Selection, Design and Verification Rules for Process Equipment
Professional Standard - Agriculture
- NY 335-1998 Production technological process of yield-increasing bacteria
- QB/T 8042-2024 Sterilized milk process specifications
- NY/T 1206-2006 Irradiation practice for the control of microflora in teas
American National Standards Institute （ANSI)
- ANSI/AAMI ST27-1988 Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization
- ANSI/AAMI/ISO 11607-2:2019 Packaging for terminally sterilized medical devices— Part 2: Validation requirements for forming, sealing and assembly processes
- ANSI/AAMI/ISO 13408-3:2006 Aseptic Processing of health care products - Part 3: Lyophilization
Association Francaise de Normalisation
- NF S98-052-2/A1:2014 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes - Amendment 1
SCC
- BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
RU-GOST R
- GOST R 27.403-2009 Dependability in technics. Compliance tests plans for reliability
- GOST R 27.404-2009 Dependability in technics. Compliance test plans for steady-state availability
Korean Agency for Technology and Standards (KATS)
- KS P ISO 13408-3:2010 Aseptic processing of health care products－Parts 3：Lyophilization
- KS P ISO 11607-2:2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
International Organization for Standardization (ISO)
- ISO 13408-3:2006 Aseptic processing of health care products - Part 3: Lyophilization
German Institute for Standardization
- DIN EN ISO 11607-2/A11:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
- DIN EN ISO 11607-2:2020-05 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 / Note: To be amended by DIN EN ISO 11607-2/A1 (2022-08).
KR-KS
- KS P ISO 11607-2-2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
European Committee for Standardization (CEN)
- EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
CEN - European Committee for Standardization
- EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition@ validation and maintenance of a sterilization process
British Standards Institution (BSI)
- BS EN ISO 13408-7:2015 Aseptic processing of health care products. Alternative processes for medical devices and combination products
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