Norm

NEN-EN-ISO 13408-2:2018 en

Aseptisch verwerken van producten in de gezondheidszorg - Deel 2: Filtering

124,99 151,24 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 34
Gepubliceerd op 01-04-2018
Taal Engels
NEN-EN-ISO 13408-2 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 sc

Details

ICS-code 11.080.01
Nederlandse titel Aseptisch verwerken van producten in de gezondheidszorg - Deel 2: Filtering
Engelse titel Aseptic processing of health care products - Part 2: Sterilizing filtration
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