What is the ISO10993 certification required for medical materials?
Medical devices have extremely high standards for raw material and supportive components, especially for first-class medical appliances. The plastic raw materials used in the products are generally required to have ISO10993 certification. What are the main contents of ISO10993 certification?
ISO10993 certification is biocompatibility certification, which refers to the compatibility between medical materials and the physiological system. The equivalent domestic certification standard is CB/T16886. The biocompatibility of medical materials is an imperative certification currently and an important indicator to ensure the safety performance of medical devices. ISO10993 lists 20 mandatory standards in detail to evaluate the biocompatibility of medical materials. Three common standards are cytotoxicity test, skin irritation test, and sensitization test. Before the project begins, it is necessary to verify the ISO10993 report of the raw material to make sure that the product will not cause bad reactions when touching the human body.
Shanghai Future Mould is a professional injection mold factory, specializing in medical products. We have accumulated rich experience and have successively achieved medical injection products for many medical devices companies. Thanks to long-term production accumulation, we currently have a complete medical material supply chain, including masterbatch, raw materials, metal accessories, etc. which can ensure the traceability of the material. Finally, we will provide all the material certifications and reports, mold qualification reports, and product quality inspection reports to our customers for further medical tests. If you have medical products that need to be manufactured, you can contact us for support.
