GB/T 16886.10-2024

This standard specifies test methods for evaluating the potential of medical devices or their constituent materials to cause skin sensitization (allergic contact dermatitis). It is applied during the biological safety assessment of medical devices, particularly for materials that come into direct contact with skin, such as wound dressings, surgical gloves, or implantable device components. The testing context includes in vivo animal models (e.g., guinea pig maximization test) to predict human allergic responses, ensuring compliance with regulatory requirements for market approval.