Standard

NS-EN ISO 13408-2:2011

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 13408-2:2018

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Referanser i lov

EU lov: 90/385/EEC, 93/42/EEC, 98/79/EC

Produktrelasjon

Produkt livssyklus