ISO 10993
ISO 10993 evaluates the compatibility of medical materials/devices, ensuring that substances released during use of items in contact with the human body do not cause cytotoxic, carcinogenic, or reproductive effects. It also ensures that exposure to the material does not induce inflammatory, immune, toxic, or thrombogenic reactions.
Core Materials offers biocompatible polymers designed for both short-term and long-term implant with skin, tissue, and blood, catering to the diverse requirements of a wide array of medical devices.
Core Materials Inc. is systematically certifying the recommended analytical items for biosafety, aligning with the specifications outlined in the following ISO 10993 standards.
- ISO 10993-4 Hemolysis Study
- ISO 10993-5 Cytotoxicity Study
- ISO 10993-6 Muscle Implantation Study
- ISO 10993-10 Intracutaneous Study
- ISO 10993-11 System Toxicity Study
Through Hemolysis Study (ISO 10993-4), Cytotoxicity Study (ISO 10993-5), Muscle Implantation Study (ISO 10993-6), and Intracutaneous Study (ISO 10993-10), ensures the inertness of our products when in contact with blood, cells, and tissues. This meticulous approach guarantees that our products do not trigger human immune responses or induce local adverse reactions. Additionally, System Toxicity Study (ISO 10993-11) confirms the absence of inherent risks for systemic toxicity, even with prolonged presence in the body.
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