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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 041 Date of Entry 04/04/2016 
FR Recognition Number 5-99
Standard
ASTM D4332-14
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
Scope/Abstract
This practice provides for standard and special conditioning and testing atmospheres that may be used to simulate particular field conditions that a container, package, or packaging component may encounter during its life or testing cycle.

This practice describes procedures for conditioning these containers, packages, or packaging components so that they approach or reach equilibrium with the atmosphere to which they may be exposed. This standard is commonly used for conditioning when conducting transit simulation tests.
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*
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
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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