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EN ISO 13408-2:2011 Standard

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  Keywords:

#part #filtration #applicable #filter #aseptic

This standard is superseded by:
  •   EN ISO 13408-2:2018
  •   Directive

    In vitro diagnostic medical devices Directive (98/79/EC)

      Last Official Journal reference

    Thursday 15th of April 2021

      Description:

    Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

      Purpose

    This part of ISO 13408 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. This part of ISO 13408 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).

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-09-30

      Related Standards

    EN ISO 11737-2:2020

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

    EN ISO 13408-3:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

    EN 13612:2002/AC:2002

    In vitro diagnostic medical devices Directive (98/79/EC)

    Performance evaluation of in vitro diagnostic medical devices

    EN 13612:2002

    In vitro diagnostic medical devices Directive (98/79/EC)

    Performance evaluation of in vitro diagnostic medical devices

    EN ISO 13408-7:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

    EN ISO 13408-6:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

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