STN EN ISO 13408-2
| Name: | STN EN ISO 13408-2 |
| Validity: | Valid |
| Number of pages: | 50 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Aseptické spracovanie výrobkov na zdravotnú starostlivosť. Časť 2: Sterilizujúca filtrácia (ISO 13408-2: 2018) |
| English title | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| Release Date: | 01. 09. 2018 |
| Date of withdrawal: | |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 6537 |
| Level of incorporation: | idt EN ISO 13408-2:2018, idt ISO 13408-2:2018 |
| Official Journal | 08/18 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 13408-2:2011-10 (85 6537) |
| Note in Official Journal: | |
| Subject of the standard: | This document 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. This document 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). This document is not applicable to high efficiency particulate air (HEPA) filters. This document 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. |
| Preview: | Náhľad normy (PDF) |