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Medical-grade silicone has been tested and certified to meet biocompatibility standards (ISO 10993 or USP Class VI). It's used in surgical implants, catheters, and prosthetics. For sex toys, "medical-grade" means the silicone has been tested for cytotoxicity, sensitization, and irritation. Not all body-safe silicone is medical-grade — that requires specific certification and testing. Brands like Fun Factory and We-Vibe use certified medical-grade silicone. The distinction matters most for people with sensitivities or allergies.