ISO 10993-11 outlines the general considerations required to assess toxicity of medical devices. Repeat dose toxicity or continuous dosing over a defined period of time is important to determine the subacute to chronic effects of a device.
These study protocols are developed based on route of patient exposure and contact duration. The typical routes of administration include intravenous or intraperitoneal injection; however, test articles may be assessed through dermal, ocular or mucosal application. In addition, device materials may be implanted subcutaneously or intramuscularly. Longer term studies include hematology, clinical chemistry, necropsy and histopathology.
