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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 14-512
ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
U.S. Identical Adoption
ANSI AAMI ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
Scope/Abstract
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 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.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 13408-2 First edition 2003-03-15 [Rec# 14-138] will be superseded by recognition of ISO 13408-2 Second edition 2018-01 [Rec# 14-512]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-138] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 14-138] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where filtration under aseptic conditions is a component of the development and manufacture of the product.
Relevant FDA Guidance and/or Supportive Publications*
Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, Issued September 2004.
FDA Technical Contacts
 Elaine Mayhall
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6301
  Elaine.Mayhall@fda.hhs.gov
 Myra Smith
  FDA/OC/CDRH/OPEQ/OHTV/DHTVA/
  301-796-6507
  Myra.Smith@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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