Medical Device Biocompatibility Testing

Our biocompatibility testing allows the accurate characterisation of a medical device’s patient contact time and level of invasiveness. This is a fundamental step in allowing a medical device to be recognised as safe for use, and subsequently being introduced into the market. Additionally, these tests can be further utilised as an evaluating tool when comparing replacement materials during changes in manufacturing processes. All medical devices which encounter human tissue should be subject to biocompatibility testing, critically cytotoxicity evaluation.

Test labs offer tests which aid in addressing the biocompatibility of medical device materials. These tests are performed to ISO 109993-5 to determine cytotoxic potential.

Biocompatibility testing is a critical part of the regulatory approval process for medical devices. Our Cytotoxicity testing (ISO 10993-5) is a crucial test for determining the effects of any medical device that encounters human tissue. This in-vitro test involves the extraction of potential toxins from the medical device through cell culturing techniques, which is validated by the ISO 10993-12 standard. The device extracts are then exposed to mammalian cells of mice origin (L929 or BALB/3T3 cells), under a range of concentrations. Cytotoxic effects are then observed through a variety of qualitative (Colony formation) and quantitative (NRU, MTT and XTT) tests. Our service is available to all medical devices which are prepared in accordance with ISO 10993-12.