When the packaging of sterile medical devices is used by manufacturers, sterilized processors, distributors, and end-users, the transportation process during the period may also affect the outer box, primary packaging and product performance of terminally sterilized medical devices. To ensure that the packaging and products of sterile medical devices are not damaged during transportation, we can verify whether the performance of the device delivered to the user can still meet the expected performance requirements at the time of delivery by simulating the transportation process. A series of regulatory requirements and standardized test methods were issued.

ASTM D4169 2022 DC13 is an international general standard for simulated transportation testing of sterile medical device packaging, and is a recommended standard for FDA registration. Let's take a look at the test process of ASTM D4169 2022 DC13.

1. Manual handling 1 (drop test)

During transportation, the product may be subjected to manual handling (such as loading, unloading, stacking, sorting or pallet loading). These operations may cause the product to fall.

2. Carrying stacking (pressure test)

During transportation, the bottom product will be subjected to pressure from the products stacked on it, and the carrying stack can be used to determine the ability of the bottom product to withstand the compressive load during transportation.

3. Unconstrained vibration (fixed frequency vibration)

Unconfined vibration is used to determine the ability of a product to withstand repetitive vibrations during bulk or unconfined transport.

4. Low air pressure test

When the product is transported by air or truck through high altitude areas, the air pressure will be relatively low, so the low air pressure test is used to verify whether the pressure drop during transportation will affect the product.

5. Carrying stacking (random vibration)

During air and truck shipments, the product will vibrate. We can verify a product's ability to withstand a vertical vibration environment during shipping.

6. Concentrated Impact

During transportation and handling, the product may be exposed to concentrated shock from exogenous sources. We can conduct a concentrated impact assessment to see if the package can withstand it.