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Medical grade silicone raw material
Purity standard: Comply with USP Class VI (U.S. Pharmacopeia) or ISO 10993 biocompatibility testing (cytotoxicity, sensitization, irritation test).
Catalyst Requirements: Platinum catalytic system must be used (to inhibit sulfide residues), peroxide sulfiding agent is prohibited (may produce low molecular weight by-products).
Additives restrictions: heavy metals (Pb, Cd, Hg, etc.) content must comply with ISO10993-17 standards (lead content ≤ 0.1ppm)
Masterbatch control
The content of barium sulfate for developing line must reach 30-40% to ensure the clarity of X-ray development (ASTM F640 standard).
Pigment must pass ISO10993-10 skin sensitization test.
Purity standard: Comply with USP Class VI (U.S. Pharmacopeia) or ISO 10993 biocompatibility testing (cytotoxicity, sensitization, irritation test).
Catalyst Requirements: Platinum catalytic system must be used (to inhibit sulfide residues), peroxide sulfiding agent is prohibited (may produce low molecular weight by-products).
Additives restrictions: heavy metals (Pb, Cd, Hg, etc.) content must comply with ISO10993-17 standards (lead content ≤ 0.1ppm)
Masterbatch control
The content of barium sulfate for developing line must reach 30-40% to ensure the clarity of X-ray development (ASTM F640 standard).
Pigment must pass ISO10993-10 skin sensitization test.
