ABSTRACT

New materials are continually being developed for various biomedical applications in an effort to maximize therapeutic benefits while minimizing adverse, or frankly toxic, effects from the biomedical intervention. The most common cause for acute biological incompatibilities of biomedical materials is the presence of biologically active leachable substances in/on the material. Most completely polymerized, chemically pure polymeric materials tend to exhibit little, if any, short-term compatibility problems with adjacent tissues. Most acute tests employed to evaluate a material for biocompatibility are, in essence, evaluating the material for the presence of biologically active leachables. In discussing the biological tests reference will be made to the biological activity of leachable or ex tractable substances from synthetic biomaterials or devices. The test has shown good correlation with the rabbit muscle implant test, but seems to be somewhat more sensitive than the muscle implant. There are a variety of ways to prepare extracts of biomaterials or devices.