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What is medical grade silicone rubber?

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.

What is medical grade silicone rubber?


Key Characteristics of Medical Grade Silicone Rubber


Medical grade silicone rubber is defined by properties that make it indispensable in healthcare:


1. Biocompatibility


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).


2. Chemical & Sterilization Resistance


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.


3. Mechanical Durability


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.


4. Thermal Stability


It retains flexibility across extreme temperatures (-60°C to 250°C), suitable for cryogenic storage and high-temperature sterilization.



What is medical grade silicone rubber?

How Medical Grade Silicone Rubber is Manufactured


The production of medical grade silicone rubber involves precision processes to ensure purity and consistency:


1. High-Purity Raw Materials


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)


2. Stringent Quality Control


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)


Applications in Healthcare


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


What is medical grade silicone rubber?

Why Choose Jinan Chensheng Medical as Your Partner?


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:


1. Comprehensive Product Portfolio


Our medical silicone rubber products include:


  • Reinforced/sterilizable tubing

  • Radiopaque catheter shafts

  • Custom-molded components


2. OEM/ODM Expertise


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)


3. Global Certifications


  • ISO 13485:2016, FDA 21 CFR 177.2600, and EU MDR (2017/746) compliant

  • Full documentation for regulatory submissions (DMF files, batch test reports)


4. Proven Track Record


  • 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


5. Cost-Effective Wholesale Pricing


Leveraging scale and vertical integration, we offer competitive pricing with flexible MOQs (500 meters for standard tubing).


Ready to Discuss Your Project?


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.



Let’s build safer medical devices together.


One of China's pioneering medical silicone product manufacturers with global exports to Europe, Southeast Asia, Africa and beyond

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