Medical Grade Silicone Sheeting
Medical Grade Silicone Sheeting is a solid silicone elastomer formulated from domestically produced silicone rubber. Per the supplier’s documentation, the material family is offered for medical-device applications including implant contact up to 29 days in the human body, and is referenced to USP Class VI, European Pharmacopeia, ISO 10993, and FDA 21 CFR 177.2600 (a food-contact composition standard); the supplier states it is free of organic plasticizers, phthalates, and peroxide cure by-products. Suitability for any implant or patient-contact use must be verified against the supplier’s current documentation for the specific grade and lot, and evaluated by the device maker for the intended device. Available from 10 to 70 Shore A durometer in gloss or matte finish, in thicknesses from .010″ to .500″ and widths up to 60″; this is a made-to-order product with an operating range of -80°F to +450°F (500°F intermittent).
Key Properties
- Durometer, Shore “A”: 30 ±5 to 70 ±5 (seven grades) — ASTM D2240
- Tensile Strength, psi: 1100–1350 (varies by grade) — ASTM D412
- Elongation, %: 600–900 (varies by grade) — ASTM D412
- Tear, ppi Die “B”: 170–205 (varies by grade) — ASTM D624
- Service Temperature: -80°F to +450°F (500°F intermittent)
Specifications: USP Class VI; European Pharmacopeia; ISO 10993; FDA Title 21 CFR 177.2600
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Physical Properties
| Property | Test Method | 30 Duro | 40 Duro | 50 Duro | 55 Duro | 60 Duro | 65 Duro | 70 Duro |
| Durometer, Shore “A” | ASTM D2240 | 30 ±5 | 40 ±5 | 50 ±5 | 55 ±5 | 60 ±5 | 65 ±5 | 70 ±5 |
| Tensile Strength, psi | ASTM D412 | 1100 | 1100 | 1250 | 1300 | 1300 | 1350 | 1300 |
| Elongation, % | ASTM D412 | 900 | 850 | 850 | 700 | 800 | 700 | 600 |
| Tear, ppi Die “B” | ASTM D624 | 170 | 170 | 205 | 180 | 205 | 185 | 185 |
Compliance
- USP Class VI — Compliant
- European Pharmacopeia — Compliant
- ISO 10993 — Compliant
- FDA Title 21 CFR 177.2600 — Compliant
- Medical device seals and gaskets requiring USP Class VI and ISO 10993 compliance
- Short-term implantable components rated for use up to 29 days in the human body
- Surgical instrument sealing and insulation requiring steam or gamma sterilization compatibility
- Pharmaceutical processing seals and gaskets in regulated production environments
- Die-cut medical-grade gasketing and sheeting for device assembly
Common industries: Medical devices, pharmaceutical processing, life sciences, surgical instruments.
Medical Grade Silicone Sheeting is a solid silicone elastomer product line manufactured from domestically produced silicone rubber and formulated to meet the strictest biocompatibility and regulatory requirements for use in medical devices and human implant applications.
The material is rated for short-term implant use up to 29 days and is certified to USP Class VI, European Pharmacopeia, ISO 10993, and FDA Title 21 CFR 177.2600 — the full complement of standards commonly required across U.S. and international medical device programs. It contains no organic plasticizers, phthalates, or peroxides, and carries no smell or odor.
Available from 10 to 70 Shore A durometer as a made-to-order product, it is supplied in gloss or matte finish in thicknesses from .010″ to .500″ and widths up to 60″.
Medical Grade Silicone Sheeting delivers strong mechanical performance across its durometer range — tensile strength ranges from 1,100 to 1,350 psi and tear resistance from 170 to 205 ppi Die “B” depending on grade, with elongation values between 600% and 900%. The material is safe for steam and gamma sterilization, enabling use across a broad range of device cleaning and sterilization protocols.
UV and ozone resistance, combined with the broad -80°F to +450°F (500°F intermittent) service range, support use in demanding device environments where environmental stability is required.
Compliant with USP Class VI, European Pharmacopeia, ISO 10993, and FDA Title 21 CFR 177.2600.
What differentiates Medical Grade Silicone Sheeting from standard commercial-grade silicone sheeting?
Medical Grade Silicone Sheeting is formulated from domestically produced silicone rubber and certified to USP Class VI, European Pharmacopeia, ISO 10993, and FDA Title 21 CFR 177.2600 — a combination of biocompatibility qualifications that standard commercial silicone grades do not carry. It is also free of organic plasticizers, phthalates, and peroxides, and is rated for short-term implant use up to 29 days, making it appropriate for regulated medical device programs where standard silicone is not an acceptable substitute.
Why does elongation matter in medical-grade silicone sheeting selection?
High elongation — ranging from 600% to 900% across Medical Grade Silicone Sheeting grades — indicates the material's ability to stretch and conform to irregular sealing surfaces without tearing or losing elastic recovery. In medical device applications, conformability under low or variable clamping loads is often critical to maintaining a reliable seal without excessive compression force, particularly in delicate instrument assemblies or implantable components where tissue or device geometry constrains the sealing interface.
What is the operating temperature range for Medical Grade Silicone Sheeting?
-80°F to +450°F (500°F intermittent), as listed on the TDS.
Is Medical Grade Silicone Sheeting suitable for sterilization environments?
Yes. Medical Grade Silicone Sheeting is safe for steam and gamma sterilization, supporting use with the most common sterilization protocols in medical device manufacturing and surgical instrument processing.
How should Medical Grade Silicone Sheeting be specified?
Specify Medical Grade Silicone Sheeting, durometer (30, 40, 50, 55, 60, 65, or 70 Shore A), thickness, finish (gloss or matte), applicable compliance standards (USP Class VI, ISO 10993, CFR 177.2600 as required), dimensional tolerances, and finished format. Note that Medical Grade Silicone Sheeting is a made-to-order product.
