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.