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AAMI ANSI/AAMI/ISO 13408-2:2018

Aseptic processing of health care products—Part 2: Sterilizing filtration
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AAMI ANSI/AAMI/ISO 13408-2:2018

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

PUBLISH DATE 2018
AAMI ANSI/AAMI/ISO 13408-2:2018
This document 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 selection, set up, validation and routine operation of a sterile-filtration process to be used for aseptic processing of health care products. This document does not apply to removal of mycoplasma or viruses by filtration nor to filtration of whole cell vaccines.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 13408-2
Publication Date Jan. 1, 2018
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Jan. 1, 2018 Revision