ABSTRACT
Biological evaluation of medical devices is performed to determine the potential toxicity resulting from contact of the component materials of the device with the body. When selecting the appropriate tests for biological evaluation of a medical device, one must consider the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body. In 1986, Food and Drug Administration, Health and Welfare Canada, and Health and Social Services UK issued the Tripartite Biocompatibility Guidance for Medical Devices. International Standards Organization (ISO) is in the process of publishing a series of standards on the biological evaluation of medical devices—ISO 10993. The need to evaluate a medical device biologically depends on the material used in the device, the intended body contact, and the duration of that contact. ISO 10993-12 describes how samples for biological evaluation should be selected, prepared, and extracted. Other guidelines provide similar descriptions, which differ slightly in the specifics of the extraction procedures.
