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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This standard is superseded by: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

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th 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    This standard has been withdrawn on 2021-09-30

      Reference

    This standard supersedes the "EN 13824:2004"

    Anyway is still possible use the "EN 13824:2004" until December 31st, 2011

      Related Standards

    EN ISO 10993-13:2010

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

    EN ISO 13408-4:2011

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN ISO 11138-3:2009

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

    EN ISO 11140-1:2009

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

    EN ISO 11607-1:2009

    Active implantable medical devices Directive (90/385/EEC)

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

    EN ISO 11737-1:2006

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

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