Medical Silicone Injection Molding
Custom injection molding for silicone parts in medical devices and health care applications
Certifications ISO 9001:2015| CTQ Inspections | ITAR
ISO 13485 certification available through Protolabs Network
What is Medical-Grade Silicone Rubber?
Liquid silicone rubber (LSR) is a synthetic elastomer within which silicone is the dominant element in each long-chain molecule. Because of its application within the medical environment, this grade of silicone must meet stringent quality standards, so the material is highly purified and tested, receiving certification from agencies such as the Food and Drug Administration (FDA). Moreover, when used in medical devices or in objects that contact human or animal tissue, any application must pass U.S. Pharmacopeia (USP) Class VI testing—the highest level of certification for medical materials.
Material Properties of Medial-Grade Silicone
Liveo Class VI Elastomer C-6-550 LSR
| Specification | Nominal Value Unit | Test Method |
|---|---|---|
| Density | 1.14 g/cm3 | ISO 1183 |
| Molding Shrinkage—Flow | 2.0% | ISO 294-4 |
| Tensile Strength (200% Strain) | 0.464 ksi (3.20 MPa) | ASTM D412 |
| Tensile Elongation (at break) | >300% | ASTM D412 |
| Tear Strength | 45 kN/m | ASTM D624 |
| Durometer Hardness (Shore A) | 52 | ASTM D2240 |
| Service Temperature (maximum) | 401°F (205°C) | n/a |
This biocompatible material is resistant to chemicals, high and low temperatures, and UV light, making it ideal for medical applications. Other characteristics include:
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Liquid Silicone Rubber Molding Capabilities
Our basic guidelines for silicone rubber molding include important design considerations to help improve part moldability, enhance cosmetic appearance, and reduce overall production time. View our design guidelines page for more details.
| US | Metric | |
| Size | 12 in. x 8 in. 4 in. | 304.88mm x 203.2mm x 101.6mm |
| Volume | 13.3 cu. in. | 217,948 cu. mm |
| Depth |
No greater than 2 in. from any parting line; deeper parts are limited to a smaller outline |
No greater than 50.88mm from any parting line; deeper parts are limited to a smaller outline |
| Projected Mold Area | 48 sq. in. | 30968 sq. mm |
Tolerances: Protolabs can maintain a machining tolerance of +/- 0.003 in. (0.08mm) with a linear tolerance of +/- 0.025 in./in. (0.025mm/mm).
Applications for Medical Silicone Rubber
Medical LSR is common used for:
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