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Simulated Transportation Testing of Sterile Medical Device Packaging - ASTM D4169

Simulated Transportation Testing of Sterile Medical Device Packaging - ASTM D4169

  • Time of issue:2022-08-29
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Simulated Transportation Testing of Sterile Medical Device Packaging - ASTM D4169

When the packaging of sterile medical devices is used by manufacturers, sterilization processors, distributors, and end users, the transportation process may also have an impact on the outer box, initial packaging, and product performance of the final sterile medical device. How to ensure that the packaging of sterile medical devices and products are not damaged during transportation, We can verify whether the performance of the devices delivered to users can still meet the expected performance requirements at the factory by simulating the transportation process. Therefore, a series of regulatory requirements and standardized testing methods have been issued for packaging transportation testing both domestically and internationally.
ASTM D4169 2022 DC13 is an international standard for simulating transportation testing of sterile medical device packaging, and is recommended for FDA registration. Let's take a look at the testing process of ASTM D4169 2022 DC13.
1. Manual Handling 1 (Drop Test)
During transportation, products may undergo manual handling (such as loading, unloading, stacking, sorting, or pallet loading). These operations may cause the product to fall.

2. Carrier stacking (pressure test)
During transportation, the bottom product will be subjected to pressure from the products stacked on it, and the transport stack can be used to measure the ability of the bottom product to withstand compressive loads during transportation.

3. Unconstrained vibration (fixed frequency vibration)
Unconstrained vibration is used to determine the ability of a product to resist repeated vibrations during bulk or unrestricted transportation.

 

4. Low pressure test
When the product is transported by air or truck through high-altitude areas, the air pressure will be relatively low, so a low air pressure test is used to verify whether the pressure drop during transportation will have an impact on the product.

 

5. Transport stacking (random vibration)
During air and truck transportation, there may be product vibrations. We can verify the product's ability to withstand vertical vibration environments during transportation.

6. Concentrated impact
During transportation and handling, products may be subject to exogenous concentrated impacts. We can conduct a centralized impact assessment on whether the packaging can withstand it.

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