GB/T 16886.9-2022

This standard provides a framework for identifying and quantifying potential degradation products from medical devices, ensuring their biological safety evaluation. It is applied in the testing and regulatory approval of implantable or absorbable medical devices, such as orthopedic implants, drug-eluting stents, or surgical sutures, where material breakdown over time could release substances into the body. The standard guides manufacturers and testing laboratories in designing studies to characterize degradation products under simulated physiological conditions.