Medical Grade Silicone Sheets & Sheeting
High-Performance 30 to 70 Durometer Medical Grade Silicones
ElastaPro offers solid medical silicone sheets across a full range of Shore A durometers to match your specific compression set, tear resistance, and sealing requirements:
- ESS30HC – 30-Durometer Medical Grade Silicone Sheet
- ESS40HC – 40-Durometer Medical Grade Silicone Sheet
- ESS50HC – 50-Durometer Medical Grade Silicone Sheet
- ESS55HC – 55-Durometer Medical Grade Silicone Sheet
- ESS60HC – 60-Durometer Medical Grade Silicone Sheet
- ESS65HC – 65-Durometer Medical Grade Silicone Sheet
- ESS70HC – 70-Durometer Medical Grade Silicone Sheet
Product Specifications
| PROPERTIES | TEST METHOD | ESS30HC | ESS40HC | ESS50HC | ESS55HC | ESS60HC | ESS65HC | ESS70HC |
|---|---|---|---|---|---|---|---|---|
| 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 |
Technical Specifications & Manufacturing Capabilities
| Material Property | Range / Capability | Test Method |
|---|---|---|
| Material Classification | Platinum-Cured Medical Grade Silicone Sheeting | USP Class VI / ISO 10993 |
| Durometer (Hardness) | 30 to 70 Shore A | ASTM D2240 |
| Thickness Range | 0.005″ to 0.500″ (0.13 mm to 12.7 mm) | Linear Dimension |
| Standard Roll Widths | 36″ (914 mm) & 48″ (1219 mm) | Standard Production |
| Custom Sheeting Widths | Up to 62″ (1575 mm) continuous roll stock | Custom Slitting & Calendering |
| Operating Temperature | -80°F to +450°F (-62°C to +232°C) | ASTM D573 |
| Primary Cure System | Platinum-Cured (Peroxide available upon request) | Catalyzed Cross-Linking |
| Standard Finishes | Fine Fabric, Smooth Gloss, or Matte | Surface Finish |
Why Specify Platinum-Cured Medical Silicone Sheeting?
At ElastaPro, our high-purity medical silicone sheeting products are primarily catalyzed using advanced platinum-curing technology. Unlike standard peroxide-cured materials, specifying a platinum-cured medical grade silicone sheet provides critical performance advantages required for sensitive medical device manufacturing and fluid contact:
- Minimized Extractables & Leachable Compounds: Essential for devices involving direct contact with skin, blood, or biological fluids.
- No Peroxide By-Products: Eliminates material blooming and chemical residue that could compromise analytical testing or sensitive diagnostics.
- Superior Optical Clarity: Translucent medical grade silicone sheets provide visual clarity for monitoring fluid paths in lab, diagnostic, and pharmaceutical equipment.
- High Tear Strength & Resilience: Maintains structural integrity, flexibility, and sealing force under severe dynamic stress.
Regulatory Compliance & Biocompatibility
USP Class VI & ISO 10993 Certified Medical Silicone Sheet Products
Every lot of raw silicone used in our medical grade silicone sheets undergoes rigorous independent testing to guarantee compliance across medical, diagnostic, wearable, and therapeutic applications:
- Skin-Contact Devices & Wearables: Hypoallergenic, non-irritating, and non-reactive medical silicone sheeting designed for long-term skin exposure and continuous wear.
- Short-Term Implantation (Up to 29 Days): Formulations thoroughly evaluated and certified for medical component contact up to 29 days.
- Pharmaceutical & Cleanroom Processing: Compliant with Ph. Eur Monograph 3.19 for cleanroom closures, fluid delivery systems, and sanitary processing gaskets.
Advanced Sterilization Compatibility
Whether converted into die-cut parts from single medical silicone sheets or processed from continuous roll stock, ElastaPro materials retain physical properties, dimensional stability, and sealing integrity after repeated sterilization cycles:
- Autoclave / Steam Sterilization
- Gamma Radiation
- Ethylene Oxide (EtO) Gas
- Electron Beam (E-Beam) Processing
Common Engineering Applications for Medical Silicone Sheets
Because of its biological inertness, low compression set, and thermal stability, our medical grade silicone sheeting is trusted by leading healthcare OEMs and die-cutters for:
- Diagnostic Equipment Enclosures: Low closure-force environmental seals protecting internal sensors and microelectronics from liquid ingress.
- Wearable Health Monitors: Flexible sensor backings, skin-contact patches, and hypoallergenic device housings.
- Fluid Management & Diagnostics: Precision peristaltic pump seals, valve diaphragms, and pharmaceutical fluid transfer gaskets.
- Surgical & Laboratory Instruments: High-purity seals for sterilization trays, analytical instruments, and diagnostic test cartridges.
- Custom Compounding & Calendering: We also supply medical-grade uncured compounds engineered for immediate calendering, custom molding, or precision extrusion.
What is Medical Grade Silicone?
Medical manufacturing demands materials that are safe, stable, and capable of performing reliably in environments where human health is at stake. That’s why so many engineers and OEMs ask the same foundational question: what is medical grade silicone? At its core, medical grade silicone is a highly purified, biocompatible elastomer engineered to meet strict standards for use in medical devices, pharmaceutical processing, and healthcare equipment. Its unique combination of cleanliness, flexibility, and chemical stability makes it one of the most trusted materials in modern medical design.
Understanding What Makes Silicone “Medical Grade”
It helps to look at the characteristics that set it apart from general‑purpose silicone. Medical grade silicone is formulated, processed, and tested to ensure it can safely contact skin, tissue, bodily fluids, and sensitive pharmaceutical media. This includes:
- Biocompatibility testing to confirm the material does not cause irritation, toxicity, or adverse biological reactions.
- High‑purity formulations with tightly controlled additives and cure systems.
- Consistency and traceability across batches to support regulatory compliance.
- Compatibility with sterilization methods such as autoclave, gamma radiation, and ethylene oxide.
These attributes make medical grade silicone suitable for components that must perform flawlessly in critical environments.
Healthcare and Life Science Applications
Its stability, softness, and resistance to chemicals and temperature extremes make it ideal for:
- Seals and gaskets in medical devices
- Pharmaceutical and biotech processing equipment
- Tubing, valves, and fluid‑handling components
- Wearable medical products and patient‑contact interfaces
- Single‑use systems and high‑purity assemblies
Because ite maintains its properties under stress, sterilization, and repeated use, it supports both disposable and long‑term medical products.
The Role of Testing and Standards
A key part of defining what is medical grade silicone involves the standards it meets. While requirements vary by application, medical grade silicone often aligns with:
- USP Class VI biocompatibility testing
- ISO 10993 medical device biological evaluation
- FDA compliance for food and drug contact
- Pharmaceutical purity expectations for processing environments
These standards help ensure that silicone components perform safely and predictably in regulated industries.
Supporting Modern Innovation
Its versatility allows designers to create components that are:
- Flexible yet durable
- Chemically resistant
- Stable across wide temperature ranges
- Suitable for precision molding and extrusion
- Available in custom formulations for specialized performance
What is Medical Grade Silicone Explained
If you’re exploring what is medical grade silicone, the answer centers on purity, biocompatibility, and reliability. It’s a material engineered to meet the demanding needs of medical and pharmaceutical environments—offering safety, stability, and performance where it matters most. Whether used in seals, tubing, wearable devices, or processing equipment, medical grade silicone remains one of the most trusted elastomers in the industry.
Frequently Asked Questions (FAQ)
What is the difference between platinum-cured and peroxide-cured medical silicone sheeting?
Platinum-cured medical silicone sheeting utilizes a platinum-catalyzed cross-linking process that produces a clean finished elastomer with higher tear strength, exceptional clarity, and zero volatile peroxide residue. This prevents blooming and extractables, making platinum-cured medical silicone sheets the preferred standard for fluid transfer, medical devices, and analytical equipment.
Can ElastaPro supply medical grade silicone sheets with custom widths and thicknesses?
Yes. We manufacture medical grade silicone sheets and continuous sheeting in standard thicknesses from ultra-thin 0.005″ up to 0.500″. While standard roll widths are 36″ and 48″, ElastaPro offers custom slitting and calendering up to 62″ wide. This extra width maximizes nested yield and reduces waste for converters using high-speed die-cutting or waterjet equipment.
How well does a medical silicone sheet perform under repeated sterilization?
An ElastaPro medical silicone sheet exhibits extreme thermal and environmental stability. The elastomer retains its mechanical strength, elasticity, and sealing properties through multiple standard sterilization cycles, including steam autoclaving, Gamma radiation, Ethylene Oxide (EtO) gas, and E-beam processing.
Can medical grade silicone sheets be backed with pressure-sensitive adhesives (PSA)?
Yes. Our solid medical silicone sheets and continuous sheeting can be laminated with high-performance pressure-sensitive adhesives (PSA) or acrylic transfer tapes. For direct skin-contact applications, we recommend specialized medical-grade adhesive composites designed for hypoallergenic skin adhesion and clean removal.
