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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 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
Identical Adoption
ANSI AAMI ISO 13408-7:2012 (R2018)
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Poulomi Nandy
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-7048
  Poulomi.Nandy@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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