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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 020 Date of Entry 09/09/2008 
FR Recognition Number 14-240
Standard
ISO  13408-5 First edition 2006-11-15
Aseptic processing of health care products - Part 5: Sterilization-in-place
Identical Adoption
ANSI AAMI ISO 13408-5:2006/(R)2015
Aseptic processing of health care products - Part 5: Sterilization in place
Scope/Abstract
ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.
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.

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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