Qualitative and quantitative methods used to satisfy ISO 10993-18:biological evaluation of medical devices-material and chemical characterization

摘要

The international standard 10993 has been and continues to be the driving force behind the biological safety evaluation of biomaterials and medical devices. An important step in the process is that of characterizing the materials and the chemicals that can migrate or extract from the polymer components to the patient. Such basic information is critical to understanding biological response and risk management of the device. Whether to evaluate the polymer, simulated extracts, or degradation products will be discussed. Appropriate testing to do at the raw material, component part and final device stages will be presented.