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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Recognition 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
U.S. 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.
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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