Medical Silicone Injection Moulding
Custom injection moulding for silicone parts in medical devices and health care applications
Certifications ISO 9001:2015| CTQ Inspections
ISO 13485 certification available through Protolabs Network
Recommended Silicones for Medical Applications
Liquid silicone rubber (LSR) is a synthetic elastomer in which silicone is the main component of each polymer chain. For healthcare and medical-related uses, materials are selected based on their purity, biocompatibility, and performance under demanding conditions.
Our medical silicones meet stringent internal quality standards and hold relevant material approvals. These silicones are widely used in medical applications due to their:
- Excellent mechanical strength and flexibility
- Chemical and temperature resistance
- Biocompatibility and stability
- Resistance to UV and sterilisation processes
Our Silicone Materials for Medical Applications
| Material Name | Flame Rating | Hardness (Shore A) | Description | Learn More |
|---|---|---|---|---|
| Elastosil 3003/30 A/B | HB | 30 | Liquid silicone rubber (LSR) from the ELASTOSIL® LR 3003 series. Paste-like, easily pigmentable two-component compound with short curing times. Offers high transparency and excellent mechanical and electrical properties. | Data Sheet |
| Elastosil 3003/50 A/B | HB | 50 | Same base as 3003/30 with higher hardness, offering durability while maintaining flexibility and transparency. | Data Sheet |
| Elastosil 3003/60 A/B | HB | 60 | Balanced performance between flexibility and rigidity. Ideal for components requiring dimensional stability. | Data Sheet |
| Elastosil 3003/70 A/B | HB | 70 | Higher Shore A hardness for applications requiring greater rigidity and wear resistance. | Data Sheet |
| KEG 2003H-30 A/B | HB | 30 | Medical-grade silicone compound providing excellent flexibility and elasticity for soft components. | Data Sheet |
| KEG 2003H-40 A/B | HB | 40 | Offers a balance of flexibility and strength, suitable for general medical applications. | Data Sheet |
| KEG 2003H-60 A/B | HB | 60 | Provides increased hardness and durability while maintaining good mechanical performance. | Data Sheet |
| KEG 2003H-70 A/B | HB | 70 | Designed for applications requiring higher rigidity and shape retention under load. | Data Sheet |
These biocompatible materials are 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 Moulding Capabilities
| Our basic guidelines for silicone rubber moulding include important design considerations to help improve part mouldability, enhance cosmetic appearance, and reduce overall production time. View our design guidelines page for more details. |
| Metric | |
| Size | 304mm x 203mm x 100mm |
| Volume | 217,000 mm³ |
| Depth |
No greater than 50mm from any parting line; deeper parts are limited to a smaller outline |
| Projected Mould Area | 31,200 mm² |
Tolerances: Protolabs can maintain a machining tolerance of 0.08mm with a linear tolerance of +/- 0.025mm.
Applications for Medical Silicone Rubber
Medical LSR is common used for:
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Medical Silicone FAQs
What is liquid silicone rubber (LSR)?
expand_less expand_moreLiquid silicone rubber (LSR) is a high-purity synthetic elastomer made primarily from silicone polymers. It offers excellent flexibility, chemical resistance, and biocompatibility, making it ideal for medical and healthcare applications.
Is the silicone used in medical parts considered “medical-grade”?
expand_less expand_moreIn EMEA, the term “medical-grade” is used carefully, as certification standards differ from the U.S. FDA system. While Protolabs’ silicones meet strict internal quality standards and may have FDA recognition, this does not automatically translate to European medical approval. Materials are selected based on their performance and suitability for medical use.
Can Protolabs produce parts that meet ISO 13485 requirements?
expand_less expand_moreYes. ISO 13485-certified production is available through the Protolabs Network for customers who require manufacturing within a certified quality management system.
What are the main benefits of silicone for medical applications?
expand_less expand_moreSilicone offers a unique combination of:
- Biocompatibility and chemical stability
- Resistance to high and low temperatures
- Flexibility and elasticity
- Odorless and inert characteristics
- Resistance to sterilisation and UV light
These properties make it ideal for demanding medical environments.
How long does it take to produce silicone moulded parts?
expand_less expand_moreLead times vary depending on part complexity, volume, and finishing requirements. Simple prototype parts can often be produced within days, while production volumes may take longer to allow for inspection and documentation.
What documentation is provided with medical silicone parts?
expand_less expand_moreEach order includes relevant quality and material documentation, such as certificates of conformity (CoC), inspection reports, and, where applicable, traceability information for medical use.
Why choose silicone for medical applications in EMEA
expand_less expand_moreSilicone’s biocompatibility, flexibility, and resistance to sterilisation make it a trusted material across European healthcare sectors. Combined with Protolabs’ precision manufacturing, customers can confidently develop safe, high-performing medical components aligned with EMEA standards and expectations.