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Aseptic processing of health care products — Part 2: Sterilizing filtration
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. ISO 13408-2:2018 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines). ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters. ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 34 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 13408-2:2018 | Aseptic processing of health care products — Part 2: Sterilizing filtration | 2018-01-09 | 표준 |
| 2 | ISO 13408-2:2003 | Aseptic processing of health care products — Part 2: Filtration | 2003-03-26 | 구판 |
ISO 13408-4:2005 - Aseptic processing of health care products — Part 4: Clean-in-place technologies 상세보기
ISO 13408-3:2006 - Aseptic processing of health care products — Part 3: Lyophilization 상세보기
ISO 13408-5:2006 - Aseptic processing of health care products — Part 5: Sterilization in place 상세보기
ISO 13408-7:2012 - Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products 상세보기
ISO 13408-6:2021 - Aseptic processing of health care products — Part 6: Isolator systems 상세보기
ISO 13408-1:2023 - Aseptic processing of health care products — Part 1: General requirements 상세보기
ISO 13408-5:2006 - Aseptic processing of health care products — Part 5: Sterilization in place 상세보기
ISO 13408-4:2005 - Aseptic processing of health care products — Part 4: Clean-in-place technologies 상세보기
ISO 13408-3:2006 - Aseptic processing of health care products — Part 3: Lyophilization 상세보기
ISO 13408-6:2021 - Aseptic processing of health care products — Part 6: Isolator systems 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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