ASTM D4169

ASTM D4169 is a standard packaging test that evaluates how a shipping container or packaging system performs when subjected to hazards found within a typical distribution environment. If you plan to distribute your product, this type of testing is an invaluable tool that can assess package performance while mitigating potentially costly points of failure.


What is ASTM D4169?

ASTM D4169 is a packaging test standard that outlines specific parameters for how testing procedures should be completed when evaluating shipping containers and packaging systems. ASTM D4169 utilizes different types of tests, such as drop testing, vibration testing, compression testing, and incline impact tests to evaluate a packaging system’s ability to withstand the distribution environment. This type of testing, categorized as transportation and distribution testing, is required for all shipping containers that contain medical devices. 

In order to accurately and uniformly understand how a shipping container or packaging system will hold up in a distribution environment, the test standard must indicate parameters that represent realistic scenarios. 

To test for anticipated hazards, ASTM D4169 includes a selection of 18 distribution cycles (DC), which are related to the mode of transportation used (i.e., air, train, truck), not the product type. Each DC represents a combination of travel types and the associated risks they pose to the products being transported. 

For example, DC 13 simulates a distribution process that involves intercity air freight and local motor freight for a single package up to 150 lb. If there is not a distribution cycle that accurately represents your distribution route, you can select the standard’s DC 2 option, which allows packaging engineers to create a custom combination of distribution hazards.

After you’ve chosen the suitable DC, you’ll need to choose an assurance level (AL). The AL is selected based on the likelihood of certain events occurring, such as drop heights, compressive loads, and vibration intensity. When choosing the AL, product cost and patient risk are also taken into account. Assurance levels range from I to III, with AL I being the most severe and AL III being the most conservative option. Generally, AL II is recommended.

What are the typical parameters for ASTM D4169 testing?

  • Distribution Cycle (DC): 1 to 18
  • Assurance Level (AL): I to III
  • Number of Samples: 1 or more for critical shipments
  • Specimen Dimensions: Same as actual distribution
  • Conditioning and Testing Temperature: Ambient unless otherwise specified
  • Conditioning and Testing Relative Humidity: Ambient unless otherwise noted

How do I know which distribution cycle and assurance level to test for with ASTM D4169 testing?

Selecting the appropriate distribution cycle and assurance level is a critical component of ASTM D4169 testing. These considerations help ensure your sample will be tested accurately under circumstances that reflect the real-life distribution process.

To identify the distribution cycle, consider the steps your package will take throughout the distribution process. For example, will it be transported by air, rail, sea, or truck? How far will the package travel during each phase of distribution — cross country or locally? The answers to these questions will help you select the right DC for your test sample.

As for the assurance level, you’ll need to determine the level of risk involved during the distribution process. To test for severe conditions, use AL I; for minimal risk, use AL III; and, for moderate risk, use AL II.

If you’re unsure which DC or AL is best suited for your package, Westpak can help.

ASTM D4169-23e1 was released on March 27, 2024. What is -23e1?

The -23e1 in ASTM D4169-23e1 is the latest version of the ASTM standard. The number before the e (in this case, 23) indicates the year of the standard’s last revision, 2023. The number after the e (in this case, 1) represents the number of editorial changes made since the last technical revision. So, ASTM D4169-23e1 refers to the ASTM D4169 standard that was technically revised in 2023 and has had one editorial change. This version was released on March 27, 2024.

The -23e1 version of ASTM D4169 brought changes primarily to compression testing, the definition of small and lightweight packages, and when to use height stack values.

ASTM D4169-23e1 was released on March 27, 2024. What were the changes as compared to the -23 version?

The main editorial update removed Note 3 from Section 11.4, which allowed using a maximum 54 in (1.4 m) stack height when the vehicle height was unknown for packages less than 2 cubic feet and less than 30 lbs (13.61 kg).

Now, the only factor that allows the reduction of the vehicle stacking height to 54 in. (1.4 m) is that the package must comply with the definition of small and lightweight, which means it is less than 2 cubic feet and weighs less than 10 lbs (4.53 kg).

ASTM D4169-23 was released in February 2024. What were the changes?

Updates were made to Sections 3, 11, and 12.

Section 3

Sub-section 3.2.7 has been updated to include a new package definition. Small and lightweight packages have been defined as packages weighing under 10 lbs (4.53 kgs) with a volume below 2.0 ft3 (0.056 m3).

Section 11

A note added to sub-section 11.2, the -23 version states, “if the shipping unit is unknown, default to the shipping unit construction Type 1 Factors.”1

Newly added 11.4.1 reads “Typical shipping density (freight) factors for mixed load and LTL shipments are from 10 lb/ft3 (160 kg/m3), which represents the 40th percentile to 30 lb/ft3 (481 kg/m3, which represents the 95th percentile of measured top load packages. If the average shipping (freight) density factor (Mf) for the specific distribution system is not known, a value of 12.0 lb/ft3 (192.2kg/m3) is recommended.”1

WESTPAK’s comments:

For those manufacturers who have been utilizing the same boxes for years without any issues of compression within the distribution environment, it may be justifiable to use a shipping density of 10. For those desiring a higher margin paired with survival, WESTPAK recommends using the shipping density of 12.

For example, using an Assurance Level of I under D4169-22, a 12 x 12 x 12 inch box that weighs 30 pounds would have required a vehicle stacking top load of 800 lbf. However, with D4169-23, the same package, and situation could offer a vehicle stacking top load of 960 lbf.

Another example of this would be a 54 x 12 x 12 inch box that weighed 30 pounds would be required to assume a vehicle stacking top load of about 3,600 lbf under D4169-22. With the changes in -23, the same assurance level for the vehicle stacking top load could be 4,320 lbf.

In Section 11, for Schedules B and C regarding Stacking, -23 includes clarifying terms to help the user better select which Shipping Unit Construction to use. Also, when identical palletized shipping units are involved, the safety factor F can be reduced by 30%.

Section 12, Schedule D

Here is the change to note sub-section 12.2.1, Schedule D – Stacked Vibration, Compressive Load:

The recommended shipping density factor (Mf) has been updated from 10 to 12 lb/ft3 (192.2 kg/in3).

For the Entire Standard

There is also an added reference for ASTM F2825 – Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery that should be noted. Under Section 6 Conditioning, this included reference states (i.6.1.3) that when testing is conducted using DC-13, the F2825 environmental conditioning may also be applicable and should be considered. These are more realistic than the conditions listed in D4332, since according to F2825, the temperatures used are not absolute extremes but the recorded daily averages in cold and hot climates around the world.

1 “Reprinted, with permission, from ASTM D4169-23, Standard Practice for Performance Testing of Shipping Containers and Systems, copyright ASTM International. A copy of the complete standard may be obtained from”

Should I perform other tests on my package?

Specifically for medical device products and following distribution testing, package integrity testing determines if the primary packaging has been compromised.


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