Medical Silicone Compliance: Why It Matters

Healthcare-grade silicone elastomers must meet strict standards for purity, clarity, durability, and biocompatibility. Momentive’s Silopren™ LSR 4000 series is engineered to comply with these requirements, making it ideal for both disposable and reusable medical devices. 

Key Compliance Features

  • Biocompatibility: Safe for contact with body fluids and medications 
  • Regulatory Standards: Meets stringent healthcare regulations and ISO, USP Class VI compliance, and FDA requirements 
  • Sterilization Resistance: Maintains performance after repeated autoclave, gamma, or EO sterilization 
  • Primerless Adhesion: Bonds to substrates like PC, PBT, and copolyesters without post-curing 
  • Aging and Chemical Stability: Withstands harsh environments and extreme temperatures 

Medical Silicone Specification Checklist 

When selecting silicone for healthcare applications, ensure your material meets the critical specifications below. 

Applications in Healthcare 


Silopren™ LSR 4000 grades are used in the following: 

  • General Medical Parts: O-rings, gaskets, seals, valves, diaphragms 
  • Drug Delivery Systems: Catheters, tubing, dosage control devices 
  • Respiratory & Surgical: Masks, valves, wound drains 
  • Dental & Orthopedic: Impression molds, prosthetic components 

Download Medical Silicone Checklist

Help your end-customer material meets FDA, ISO, and USP Class VI requirements before it reaches qualification.

Click to download the compliance checklist


Or if you still require technical assistance, click the button below to talk to a silicone expert within seconds! 
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