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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Entry 09/09/2008 
FR Recognition Number 14-239
Standard
ISO 13408-3 First edition 2006-09-15
Aseptic processing of health care products - Part 3: Lyophilization
U.S. Identical Adoption
ANSI AAMI ISO 13408-3:2006/(R)2015
Aseptic processing of health care products - Part 3: Lyophilization
Scope/Abstract
ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization 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.
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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