The cell culture including cytotoxicity methods is a long established screening method for device or biomaterial biocompatibility screening and may be a fair predictor of biocompatibility when used together with other appropriate tests (Wilsnack, 1976; Gad, 2000). Several highly specialized cell culture methods are available to evaluate the biocompatibility of the raw materials used in the manufacturing of the device or auditing the production of the manufacturing process. Such cytotoxicity offers several advantages:

investigation; ● it can be used to construct a dose-response curve; and, ● it can give quick and quantitative results and allows direct

access or direct observation or measurement.