Eastar Copolyester MN021 Natural has been tested for FDA/ISO 10993 and USP Class VI Biological Evaluation testing after Gamma and EtO sterilization. Eastar copolyester MN021 Natural is a thermoplastic condensation copolymer produced by a continuous melt-phase polymerization process followed by a solid-state polymerization process. It has a relatively high flex modulus and yield strength. This product does not contain a mold release. It is a thermoplastic condensation copolymer produced by a continuous melt-phase polymerization process followed by a solid-state polymerization process. It has been crystallized. Please note that IMCD and Eastman have a medical risk assessment which we will guide you through to make sure to choose the right products for your application, i.e. Eastman products are not intended for use in body implant applications for >30days, any cardiac prosthetic device applications and specific other applications.