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ISO 13408-2:2018

Aseptic processing of health care products — Part 2: Sterilizing filtration
9. 1. 2018.

Опште информације

90.93     31. 1. 2024.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 13408-2:2003

TRENUTNO

OBJAVLJEN
ISO 13408-2:2018
90.93 Odluka o potvrđivanju standarda
31. 1. 2024.

ISPRAVKE / IZMENE

PROJEKAT
ISO 13408-2:2018/CD Amd 1

Nacionalna preuzimanja

SRPS EN ISO 13408-2:2018  
ISS

Aseptična obrada proizvoda za zaštitu zdravlja – Deo 2: Sterilizacija filtracijom

60.60   Standard objavljen

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