Medical Grade Silicone Rubber | LSR for Healthcare Applications

Medical Grade Liquid Silicone Rubber

Guangdong Anlin Technology supplies medical grade silicone rubber (LSR) meeting FDA, ISO 10993, and USP Class VI standards. Our biocompatible liquid silicone rubber is ideal for medical devices, implants, and healthcare equipment requiring the highest levels of purity and performance.

What Makes Silicone "Medical Grade"?

Medical grade silicone rubber must meet stringent regulatory requirements that go far beyond standard industrial grades. Key certifications include:

• USP Class VI – The highest USP classification for biocompatibility, testing for systemic toxicity, intracutaneous reactivity, and implantation
• ISO 10993 – Biological evaluation of medical devices, covering cytotoxicity, sensitization, and irritation
• FDA 21 CFR 177.2600 – Compliance for food and medical contact substances
• ISO 9001:2015 – Quality management system certification for manufacturing processes

These certifications ensure the material will not cause adverse biological reactions when in contact with human tissue or bodily fluids.

Properties of Medical Grade LSR

Why LSR for Medical Devices?

Liquid Silicone Rubber has become the material of choice for medical device manufacturers for several compelling reasons:

Precision and Consistency

LSR injection molding produces parts with tolerances as tight as +/-0.001 inch (0.025mm). The low viscosity of LSR allows it to fill complex mold geometries that would be impossible with high-consistency rubber, enabling intricate medical component designs.

Sterilization Compatibility

Medical devices must withstand repeated sterilization. Medical grade LSR is compatible with all common sterilization methods:

• Autoclave (steam) – 250F to 275F at 15-30 PSI, repeated cycles
• Ethylene Oxide (EtO) – Gas sterilization for heat-sensitive components
• Gamma Radiation – Up to 25 kGy without significant property degradation
• E-beam – Electron beam sterilization for surface treatment

Biocompatibility

Medical grade LSR is inherently biocompatible—it does not leach plasticizers or other harmful compounds. This makes it safe for:

• Long-term implantable devices
• Short-term surgical instruments
• Drug delivery components that contact medications
• Skin-contact wearable medical devices

Common Medical LSR Applications

• Respiratory – Face mask seals, breathing circuits, ventilator components
• Drug Delivery – Valve seals, septums, syringe components, IV connectors
• Surgical – Instrument grips, retractors, wound drainage components
• Dental – Impression trays, orthodontic products, bite registration
• Diagnostics – Lab ware, test seals, microfluidic components
• Wearables – Skin-contact bands, sensor housings, hearing aid components

Anlintech Medical Manufacturing Capabilities

Our dedicated medical production area ensures clean, controlled manufacturing:

• Cleanroom molding available (Class 10,000 / ISO Class 7)
• Material lot traceability from raw material to finished part
• 100% visual inspection plus dimensional sampling per AQL standards
• Full documentation packages: material certificates, first article reports, dimensional reports
• Custom color matching for device identification

Need medical grade silicone rubber components for your next project? Contact Anlintech for a material recommendation and free quote.