Silicone (Medical Grade)
Verifiedpolymer· PDMS· Silastic· Medical silicone· Polydimethylsiloxane
Medical-grade silicone is a biocompatible elastomeric polymer engineered to meet stringent FDA and ISO standards for prolonged contact with human tissue and body fluids. It is widely used in implantable and external medical devices where flexibility, inertness, and resistance to bodily fluids are critical—including catheters, breast implants, pacemaker housings, and seals in insulin pumps. Engineers select medical-grade silicone over commodity alternatives because its chemical stability, low inflammatory response, and ability to withstand repeated sterilization cycles make it the gold standard for applications requiring long-term biocompatibility and regulatory approval.
implantable medical devicescatheters and tubingbreast implantsdrug delivery componentspacemaker housingsorthopedic seals and gaskets
Compliance & Regulations
?UL 94?Conflict Free?FDA?RoHS?REACH?TSCA?Prop 65
| Property | Value | Unit | Conditions | Source | |
|---|---|---|---|---|---|
Elongation at Break(εf) | — | - | — | — | |
Ultimate Tensile Strength(σUTS) | — | ksi | — | — | |
Young's Modulus(E) | — | ksi | notes | — |
Verified Unverified Low confidence (<80%) Link to source
| Property | Value | Unit | Conditions | Source | |
|---|---|---|---|---|---|
Maximum Service Temperature(Tmax) | — | °F | — | — | |
Thermal Conductivity(k) | — | BTU/(hr·ft·°F) | — | — |
Verified Unverified Low confidence (<80%) Link to source
| Property | Value | Unit | Conditions | Source | |
|---|---|---|---|---|---|
Density(ρ) | — | lb/in³ | — | — |
Verified Unverified Low confidence (<80%) Link to source
Regulatory Screening
Environmental
Safety & Biocompatibility
Quality & Standards
RoHS, REACH, and Prop 65 statuses are validated against official substance lists (ECHA SVHC Candidate List, OEHHA Prop 65, RoHS Annex II). Other regulations are estimated from composition and material classification. All screening is a starting point for due diligence — always verify with your supplier before making compliance decisions.