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Standard

ISO 13408-6:2005

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: ISO 13408-6:2021

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Omfang

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Tilbaketrukket:
  • products.specs.Expires:
  • Utgave: 1
  • Versjon: 1
  • Varetype: IS
  • Products.Specs.pages
  • ICS 11.080.01
  • ISO TC ISO/TC 198

Produktrelasjon

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