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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 14-513
Standard
ASTM  F2825-18
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
Scope/Abstract
1.1 This practice provides a uniform basis for evaluating, in a laboratory, the ability of a packaging system to withstand a range of climatic stresses that a packaging system may be exposed to during distribution throughout the world and still provide the product protection from damage or alteration.

1.2 This practice is designed as conditioning prior to testing for overnight or two-day delivery systems of a single parcel packaging system or as a standalone test for climatic stressing of packaging systems.

Note 1: Practice F2825 climatic stressing or conditioning is short term in duration. Fiberboard containers are not expected to approach equilibrium moisture content at the climatic conditions used in Practice F2825. Therefore, Practice F2825 conditioning should not be used for distribution environments other than one- to two-day single parcel delivery as it may provide inaccurate or misleading test results for the fiberboard containers.

1.3 This practice does not cover refrigerated, frozen food storage, or cryogenic storage conditions. Only the climatic environments encountered in various regions of the world are covered by this practice.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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
 Matthew Beckwith
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3393
  Matthew.Beckwith@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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