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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 08/06/2013 
FR Recognition Number 14-388
Standard
ISO 13408-7 First edition 2012-08-01
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
U.S. Identical Adoption
ANSI AAMI ISO 13408-7:2012
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
Scope/Abstract
ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.

ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.

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.
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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