Material and chemical characterization for the biological evaluation of medical device biocompatibility

Abstract

Abstract: The importance of materials to the medical device industry cannot be over emphasized. Along with increased demand for medical grade materials, the medical device industry has renewed its awareness and concern for the safety of materials used. An essential part of establishing biological safety is the implementation of chemical and material characterization testing. Chemistry is often called the central science because of its role in connecting the physical sciences, which include chemistry, with the life sciences and applied sciences such as medicine and engineering. This role of chemistry as the central science is very important to medical device evaluations and is noticeably evident in the ISO 10993 approach to the biological safety evaluation of medical devices and biomaterials. Parts 18 and 19 of the 10993 series of standards are receiving even more emphasis, as they become an integral part of the biological evaluation of medical devices. An important step in the process is that of characterizing the material and identification of chemicals that can migrate or extract from the polymer components. Such basic information is critical to understanding the biological response and toxicological risk of the device since adverse effects caused by materials are generally chemical effects. In recent years there has been a great deal of discussion of the merits of chemical and material characterization. Considering the intrinsic worth of chemistry and materials characterization to biocompatibility, it seems very likely that chemical characterization will receive even more attention in the future.