ISO 13408-2:2003 Historical

1086782

Aseptic processing of health care products - Part 2: Filtration

standard by International Organization for Standardization , 03/15/2003

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Full Description

ISO 13408-2:2003 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.

ISO 13408-2:2003 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).

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Document History

  1. ISO 13408-2:2018


    Aseptic processing of health care products - Part 2: Sterilizing filtration

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  2. ISO 13408-2:2003

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    Aseptic processing of health care products - Part 2: Filtration

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Product Details

Published:

03/15/2003

Number of Pages:

11

File Size:

1 file

Same As:

AAMI/ISO 13408-2:2003/(R)2013, DIN EN ISO 13408-2, BS EN ISO 13408-2:2011

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus