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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This standard is superseded by: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    This standard has been withdrawn on 2021-09-30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 11137-2:2015

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

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

    EN ISO 15194:2009

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

    In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified refer...

    EN ISO 13408-2:2018

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

    Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

    EN ISO 11137-1:2015/A2:2019

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

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

    EN 556-1:2001

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

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

    EN 556-1:2001/AC:2006

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

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

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