EU Commission publishes harmonised aseptic processing standards

23 August 2011

The list of harmonised standards under Directive 93/42/EEC for Medical devices was revised on August 19. As of December 31 2011, the EN 13824:2004 will no longer be used as a presumption of conformity for aseptic processing and will be replaced by the EN ISO 13408 standards series:

  • EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
  • EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
  • EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
  • EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
  • EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
  • EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

View the latest list of harmonized standards on the European Commission's website.