ISO 13408-1:2008
Aseptic processing of health care products — Part 1: General requirements
Reference number
ISO 13408-1:2008
Edición 2
2008-06
Retirada
ISO 13408-1:2008
37842
Retirada (Edición 2, 2008)

Resumen

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.

Informaciones generales

  •  : Retirada
     : 2008-06
    : Retirada de la Norma Internacional [95.99]
  •  : 2
     : 45
  • ISO/TC 198
    11.080.01 
  • RSS actualizaciones

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