Cytotoxicity Testing

Mammalian tissue culture systems

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.

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If you’re seeking comprehensive medical device services, look no further than iuvo Bioscience. Our experienced team is ready to assist you with testing, evaluation, and regulatory support to ensure successful commercialization of your medical device. Contact us today to discuss your project and learn how our expertise can help you get to market fast.