PRODUCTS

The Custom High Precision Medical Silicone O-Ring is a cornerstone of reliability in medical device design, engineered to meet the stringent demands of healthcare environments. Manufactured from platinum-cured or medical-grade liquid silicone rubber (LSR), this O-ring combines exceptional biocompatibility with uncompromising precision. It complies with international standards such as USP Class VI, FDA 21 CFR 177.2600, and ISO 10993, ensuring safety in direct or indirect contact with bodily fluids, pharmaceuticals, and sterilization processes. Ideal for applications ranging from surgical instruments to diagnostic equipment and drug delivery systems, this O-ring delivers leak-proof performance, chemical resistance, and long-term stability under extreme conditions .

Key Features and Technical Advantages

1. Superior Biocompatibility and Material Purity

   Crafted from high-purity silicone, this O-ring is non-toxic, non-pyrogenic, and free of animal-derived ingredients, minimizing risks of patient irritation or immune reactions. Its inert nature prevents chemical leaching, making it suitable for implantable devices (e.g., pacemakers, insulin pumps) and pharmaceutical processing .

2. Exceptional Tolerance to Sterilization Methods

   The O-ring withstands repeated sterilization cycles, including autoclaving (up to 135°C), gamma irradiation, and ethylene oxide (EtO) gas, without degrading or losing elasticity. This ensures durability in reusable medical tools and critical care equipment .

3. High-Precision Manufacturing for Critical Seals

   Produced in ISO-classified cleanrooms with advanced molding technologies, the O-ring achieves dimensional tolerances as tight as ±0.025 mm. This precision prevents micropores or flash, reducing contamination risks in sensitive environments like surgical robots or infusion pumps .

4. Broad Operational Flexibility

   With a temperature range of -60°C to 230°C, the O-ring maintains elasticity in cryogenic storage or high-temperature sterilization. It also resists ozone, UV exposure, and chemicals like alcohols, acids, and alkalis .

5. Customization for Specialized Needs

   Available in hardness levels from Shore A 30 to 80, with options for colors (transparent, white, black) and sizes (AS568, metric, or custom dimensions). The O-ring can be tailored for specific assembly requirements, such as low compression set (<10%) for dynamic seals or FDA-compliant formulations for food and medical use .