Views: 0 Author: Kevin Publish Time: 2025-08-05 Origin: Jinan Chensheng Medical
Medical grade silicone rubber is a specialized elastomer engineered to meet the stringent safety and performance requirements of healthcare applications. Unlike industrial-grade silicone, it undergoes rigorous testing to ensure biocompatibility, chemical inertness, and safety for direct contact with human tissues and fluids. This unique material plays a critical role in medical devices, from implantable components to disposable tools, where patient safety and reliability are non-negotiable.
Medical grade silicone rubber is defined by properties that make it indispensable in healthcare:
It is formulated to eliminate adverse reactions when in contact with bodily tissues, blood, or fluids. Rigorous testing (per ISO 10993 standards) ensures no cytotoxicity, irritation, or sensitization—making it ideal for long-term implants (e.g., pacemaker leads) and short-term devices (e.g., surgical drapes).
It withstands aggressive medical substances (antibiotics, disinfectants) and repeated sterilization:
Autoclaving (134°C steam, 30+ cycles)
Ethylene Oxide (ETO) gas
Gamma radiation (25–50 kGy)
This durability ensures devices maintain integrity through multiple uses, critical for reusable surgical instruments and respiratory circuits.
With tensile strength >7 MPa and elongation >300%, it resists tearing, kinking, and deformation under stress. Reinforced variants (e.g., braided polyester) further enhance burst pressure resistance (up to 300 psi) for high-pressure applications like hemodialysis.
It retains flexibility across extreme temperatures (-60°C to 250°C), suitable for cryogenic storage and high-temperature sterilization.
The production of medical grade silicone rubber involves precision processes to ensure purity and consistency:
Only platinum-cured silicone rubber is used, avoiding peroxide catalysts that leave harmful residues. This ensures:
Heavy metal content <0.1 ppm
Extractables <0.1% (per USP Class VI)
Low volatile organic compounds (VOCs <50 ppm)
Manufacturing occurs in Class 8 cleanrooms with automated extrusion and molding equipment, ensuring dimensional accuracy (±0.02mm tolerance for tubing). Each batch undergoes testing for:
Tensile strength and elongation (ISO 37)
Hardness (Shore A 30–80, per ASTM D2240)
Biocompatibility (ISO 10993-5/-10)
Medical grade silicone rubber is used in thousands of life-saving devices:
Device Type | Application Examples |
Catheters & Tubing | IV lines, urinary catheters, respiratory circuits, dialysis tubing |
Surgical Instruments | Laparoscopic tools, endoscope sheaths, anesthesia masks |
Implants | Pacemaker leads, joint prosthetics, breast implants |
Wound Care | Negative pressure therapy systems, silicone dressings |
As a leading medical grade silicone rubber manufacturer in China with monthly production capacity of 100,000+ meters, we combine expertise, innovation, and compliance to deliver superior solutions:
Our medical silicone rubber products include:
Reinforced/sterilizable tubing
Radiopaque catheter shafts
Custom-molded components
We collaborate to develop tailored solutions:
Rapid prototyping (7–10 days)
Custom dimensions (ID 0.3mm–50mm)
Color coding (MOQ 500 meters/color) and surface treatments (hydrophilic coatings, laser marking)
ISO 13485:2016, FDA 21 CFR 177.2600, and EU MDR (2017/746) compliant
Full documentation for regulatory submissions (DMF files, batch test reports)
European Medical Device OEM: Supplied 50,000+ meters of reinforced tubing annually for hemodialysis machines
US Surgical Instrument Manufacturer: Custom-molded components with 99.7% on-time delivery
Leveraging scale and vertical integration, we offer competitive pricing with flexible MOQs (500 meters for standard tubing).
Medical grade silicone rubber is the foundation of safe, reliable medical devices. Partner with Jinan Chensheng Medical for materials that meet the highest global standards.
Explore our products: Medical Silicone Rubber Product List
Learn about us: Company Introduction
Contact us: Send inquiries to info@jngxj.cn or visit our contact page.
WhatsApp: +86-18560016197
Let’s build safer medical devices together.
