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EN ISO 13408-2:2011 Standard

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Home In vitro diagnostic medical devices Directive (98/79/EC) EN ISO 13408-2:2011
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  Keywords:

#part #filtration #applicable #filter #aseptic

This standard is superseded by: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

    •   Directive

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

      Last Official Journal reference

    Monday 19th of July 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    This standard has been withdrawn on 2021-09-30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 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)

    EN 556-2:2015

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

    Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

    EN ISO 18113-5:2011

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

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

    EN ISO 18153:2003

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

    In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for ca...

    EN ISO 20776-1:2006

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

    Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of p...

    EN ISO 23640:2015

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

    In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

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    DIRECTIVE PDF

    LAST OFFICIAL JOURNAL PDF

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