Biocompatibility testing relies on series of tests to identify the potential toxicity resulting from either contact with medical devices components or with combined products and the body.

AGINKO performs testing to evaluate biocompatibility efficiently as it tests the material the same way as its intended use. These biocompatibility tests challenge various biological models with the test material or suitable extract. 

European and North American standards for biocompatibility testing are similar but not identical. European requirements are based on ISO 10993. The US FDA has substantially adopted ISO with some differences in specific testing requirements. For tissue and bone implants, including engineered tissues and scaffold, a series of evaluation tests are required to assess biological effects. All our testing in support of regulatory submissions meets GLP (Good Labor Practise) standards.