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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 046 Date of Entry 12/23/2016 
FR Recognition Number 14-499
Standard
ASTM D4169-16
Standard Practice for Performance Testing of Shipping Containers and Systems
Scope/Abstract
1.1 This practice provides a uniform basis of evaluating, in a laboratory, the ability of shipping units to withstand the distribution environment. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles. This practice is not intended to supplant material specifications or existing preshipment test procedures.
1.2 Consider the use of Practice D7386 for testing of packages for single parcel shipments.
1.3 The suitability of this practice for use with hazardous materials has not been determined.
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.
Transition Period
FDA recognition of ASTM D4169-16 [Rec# 14-499] will be superseded by recognition of ASTM D4169-22 [Rec# 14-576]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-499] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 14-499] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where packaging is a component of the development and manufacture of the product
Relevant FDA Guidance and/or Supportive Publications*
1. ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

2. ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.

3. ISO/TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.

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)
Sterility
*These are provided as examples and others may be applicable.
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