GB/T 16886.20-2015

This standard provides principles and test methods for evaluating the immunotoxicological risks of medical devices, focusing on potential adverse immune responses such as hypersensitivity, chronic inflammation, or immunosuppression. It is applied during the biological safety assessment of medical devices that contact human tissue, blood, or implantable materials, guiding manufacturers and testing laboratories in selecting appropriate in vitro, in vivo, or ex vivo assays. The standard is particularly relevant for devices containing novel biomaterials, drug-device combinations, or those intended for long-term or permanent implantation.