Standard

ISO 13408-1:2008

Historisk utkast

Merknad: Denne standarden har en ny utgave: ISO 13408-1:2023

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ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Tilbaketrukket:
  • products.specs.Expires:
  • Utgave: 2
  • Versjon: 1
  • Varetype: IS
  • ICS 11.080.01
  • ISO TC ISO/TC 198

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