ABSTRACT
Biological performance, as defined in Chapter 1, has two aspects: material response and host response. Because the traditional approach has been to define biological performance in terms of biocompatibility (host response), and then to observe evidence of material degradation that arises during in vitro and in vivo testing, the development of tests has concentrated upon those that measure host response. In practice this has not been a bad course of events. Despite the uncertainties in both areas, it is still easier to predict material response than to predict host response. Thus, it remains a good strategy to proceed through the following five steps in early biomaterial qualification studies:
• Select candidate materials based upon engineering properties and previous material and host response information.
