Medical Grade Silicone Tube details

Overview:

Shenyun Medical Grade Silicone Tubes are specially designed to meet the high standards of biocompatibility, safety, and performance required by the medical industry. Manufactured using high-quality medical-grade silicone materials, these tubes ensure excellent durability and reliability in a variety of demanding applications. They are widely suitable for use in infusion systems, respiratory equipment, dialysis machines, urinary catheters, and other medical devices and fields.

Product Features:

· High-Quality Materials: Compliant with USP Class VI and ISO 10993 standards, ensuring non-toxic, odorless properties and excellent biocompatibility.

· Temperature Resistance: Maintains flexibility and stability across a wide temperature range, suitable for both low-temperature storage and high-temperature sterilization environments.

· High Transparency: Provides clear visual monitoring for easy observation of fluid flow, helping to identify potential issues promptly.

· Anti-Kink Design: Certain models are specially designed to prevent twisting or blockage during use, ensuring smooth operation.

· Multiple Size Options: Offers a wide range of inner diameter (ID), outer diameter (OD), and wall thickness options to suit different application scenarios.

· Easy to Clean and Sterilize: Compatible with various sterilization methods including gamma radiation and ethylene oxide (EO), and has passed ISO-11135 sterilization validation.

Production Environment & Quality Control:

· Class 100,000 Cleanroom Production: Our medical silicone tubes are manufactured in a Class 100,000 cleanroom environment that meets ISO 14644-1 standards, and acceptance reports can be provided upon request.

· Strict Microbial Control: Comprehensive initial microbial contamination control measures are implemented throughout production. Regular microbial testing is conducted on air, surfaces, and finished products to ensure that contamination levels are well below industry standards, guaranteeing product safety.

· Full Process Quality Monitoring: Every step—from raw material selection to final product release—is subject to rigorous quality inspection. All equipment, tools, and personnel that come into contact with the product undergo strict disinfection procedures and wear appropriate protective gear to minimize external contamination risks.

Technical Specifications:

· Hardness Range: Available from 20 Shore A to 80 Shore A, customizable according to specific requirements.

· Color Options: Standard transparent version; other colors available upon customer request.

· Operating Temperature: Recommended usage range is from -60°C to +200°C.

· Certifications: Certified under FDA, CE, ISO 13485, and other relevant standards, ensuring product quality and safety.

Application Scenarios:

· Infusion pumps and syringes

· Respiratory therapy equipment

· Hemodialysis machines

· Enteral nutrition delivery systems

· Laboratory analytical instruments

Customization Services:

We offer comprehensive customization solutions, including but not limited to special sizes, color variations, hardness adjustments, and added functionalities such as anti-static or antimicrobial coatings, to meet our customers' personalized needs.