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What Is Unrestricted Grade (long-term implant)?

Unrestricted grades of medical silicone are vigorously tested to ensure its capability and human use. Since unrestricted grades of medical silicone are accounted for liability issues, only a few major manufacturers supply including Applied Silicone and Nusil. Within Nusil’s restricted grade, they also have complete records of traceable processes and FDA Masterfiles. These liquid medical silicone meet or exceed all USP Class VI and many ISO-10993 test requirements which include cytotoxicity, hemolysis, systemic extracts, intracutaneous extracts, implantation, salmonella mutagen, and rabbit pyrogen test. The length of implant will be considered more than 30 days. A supplier agreement such as Wacker Health Care Guidelines, for instance, should be clarified to ensure the suitability of a certain application.

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