Mammalian tissue culture systems are currently used to evaluate biocompatibility and toxicity of materials for use in medical devices and associated products. Cell culture testing methods have shown good correlation with animal assays and are frequently more sensitive to toxic materials. Several of these cytotoxicity test procedures are widely accepted in biomaterial screening, quality control and audit programs.
In general, these in vitro techniques use a variety of cell types which differ in relative sensitivity and the time required to conduct the assay. Results obtained with cell culture methods must be evaluated in conjunction with supporting or associated in vivo studies and with the end use of the product.
Cytotoxicity tests are required as part of the ISO-10993 test matrix for all medical devices.
