Biocompatibility 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.
Submissions for approval of medical devices by regulatory agencies require that biocompatibility assessment be conducted to assure safety of the device or material. Safety data can be obtained by testing according to certain prescribed or recommended guidelines, including guidance documents developed by the International Organization for Standardization (ISO) and FDA.
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.
- ISO 10993
- United States Pharmacopeia (USP)
- European Pharmacopeia (EP)
- Japanese Ministry of Health, Labor, and Welfare (MHLW)
- Japanese Pharmacopeia (JP)
Toxikon’s Expertise in Biocompatibility Testing Services
Toxikon is well-known throughout the global medical device and combination product industries, and we have been proudly meeting the development challenges of raw material, component, and finished device manufacturers since 1977. With regulatory agencies in the U.S. and abroad, it is important to partner with a CRO that can guide you through the preclinical regulatory landscape to reach the clinical stage and, ultimately, to market. Our study directors have a deep understanding of the issues medical device makers face.