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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 14-424
Standard
ISO 13408-6 First edition 2005-06-15
Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)]
U.S. Identical Adoption
ANSI AAMI ISO 13408-6:2005/(R) 2013 & A1:2013
Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)]
Scope/Abstract
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.

ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.

ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

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.
Public Law, CFR Citation(s) and Procode(s)
This standard is relevant for all medical devices where aseptic processing 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
 Myra Smith
  FDA/OMPT/CDRH/ODE/DNPMD/NIDB/
  301-796-6507
  Myra.Smith@fda.hhs.gov
 Elaine Mayhall
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6301
  Elaine.Mayhall@fda.hhs.gov
 Steven Elliott
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-5285
  Steven.Elliott@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
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