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What is biocompatibility?
Biocompatibility simply refers to the properties of materials being biologically compatible by not eliciting local or systemic responses from a living system or tissue. From a regulatory stance, biocompatibility is a series of tests that are used to determine the potential toxicity resulting from contact of the components of medical devices or combination products with the body.
In fact, regulatory guidelines mandate that leachates of a device should not produce adverse local, systemic, tumorgenic, reproductive, or developmental effects. Evaluations of biocompatibility, which are spelled out in ISO 10993, are all part of the overall safety and efficacy assessment of medical devices, including pacemakers, hip replacements and stents, and combination products like syringes, inhalers and patches.
These safety and efficacy studies employ analytical chemistry, cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenecity, subacute/subchronic toxicity, genetic toxicology, implantation, and hemocompatibility. Supplemental evaluation studies include chronic toxicology, carcinogenicity, reproductive/development toxicology and biodegradation.
Toxikon is well-known throughout the global medical device and combination product industries, and we have been proudly meeting the development challenges of component, raw material, and finished device manufacturers since 1977.
Our facilities allow us to conduct proof of concept and efficacy studies, analytical, complete biocompatibility, extractables and leachables, microbiology, sterilization support, genetic and molecular toxicology reusable device and combination product evaluations, and more.
Click to download more information on Toxikon’s Biocompatibility Assessment services and Biocompatibility Testing Services and Guidelines.