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EN ISO 13408-2:2018 Standard

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  Keywords:

#applicable #requirements #process #filter #validation

  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: Sterilizing filtration (ISO 13408-2:2018)

  Purpose

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. ISO 13408-2:2018 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines). ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters. ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN ISO 11137-2:2015

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

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EN ISO 11607-2:2020

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EN 13975:2003

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

EN 14254:2004

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

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

EN 14820:2004

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

Single-use containers for human venous blood specimen collection

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