Заходи Huangshan, Китай 2023

The implemented standard for registering and testing in vitro diagnostic medical equipment in China is YY 0648-2008. It requires conformity checks of transport records. Previously, GB/ T 14710 was needed, but starting in 2022, the standards are GB/ T 14710, AST D4169, ISTA, and GB/T 4857. Overseas medical devices have more advanced packaging and transportation standards, but lack targeted special requirements. By exchanging information, we aim to standardize domestic transport packaging requirements and effectively evaluate the stability of in vitro diagnostic medical equipment. The design process for lithium battery packaging should focus on relevant regulations, including new and waste battery recycling.