White Paper: Medical

How Chemical Characterization Can Supplement and Support Biocompatibility Testing

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Manufacturers producing medical devices that involve patient contact are typically required to perform biological safety evaluations, including biocompatibility tests to ensure patient safety, as specified by ISO 10993. Chemical characterization can help support the biocompatibility testing process, reduce the use of animal testing, in some cases shrink turnaround time and cost, and perhaps eliminate the need to do some biocompatibility testing altogether.

Traditional biocompatibility tests involve evaluating the biological effects of compounds extracted from devices on animals (in vivo) and/or cells (in vitro). Chemical characterization of a device, in contrast, involves utilization of analytical chemistry to identify and quantify the amount of chemicals extracted from a device and an evaluation of the toxicological risk associated with the exposure level. This approach involves characterizing both the product material —typically a polymer, metal, or ceramic—and the extractable or leachable compounds that come from those materials or byproduct residuals on the device from the manufacturing process.

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