| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
059
|
Date of Entry 12/19/2022
|
|
FR Recognition Number
|
5-136
|
| Standard | |
ASTM D4332-22
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
|
Scope/AbstractThis 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
|
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. |
|
Transition Period
| FDA recognition of ASTM D4332-14 [Rec# 5-99] will be superseded by recognition of ASTM D4332-22 [Rec# 5-136]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-99] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 5-99] will not be accepted. |
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
