chapter  6
Cytotoxicity Testing
Pages 12

Cell culture, including cytotoxicity methods, is a long-established 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 to audit the production of the manufacturing process. Such cytotoxicity testing offers several advantages:

• It is simple, rather inexpensive, and easy to perform • It allows testing of a biomaterial on human tissue • It is sensitive to toxic material • It is easy to manipulate and allows more than one end-point investigation • It can be used to construct a concentration-response curve • It can give quick and quantitative results and allows direct access or direct observation or

measurement

Despite these advantages, cytotoxicity use is currently limited to screening the biomaterials and nished medical devices. Therefore, cytotoxicity results should be used for biocompatibility in conjunction with other tests.