Medical Grade HTV Silicone Rubber
Our medical grade silicone rubber – HTVWIC’s – are high-purity, odorless, and transparent compounds specifically developed for medical and healthcare applications, featuring excellent Sterilizability. Available in two distinct types, HTVWIC-P and HTVWIC-F, with hardness ranging from 30 to 70 Shore A, they come with both transparent and pigmented options. These materials are fully customizable through our in-house compounding services, allowing precise adjustment of mechanical and processing properties to meet specific customer requirements.
ISO/TS 16949
ISO 9002
ISO 3808
ISO 9001
ISIRI 4267-2
ISO 17025
10993-5
10993-10
10993-4
Pharma
ASTM F756
Key Highlights
Medical-Grade Biocompatibility
High-purity HTV silicone compliant with FDA and ISO 10993, suitable for direct medical and food-contact applications.
Non-Toxic & Additive-Free
Free from plasticizers and harmful additives, ensuring long-term safety in medical and pharmaceutical environments.
Wide Temperature Stability
Maintains flexibility and mechanical strength across a broad range from –50°C to +200°C.
Sterilization Resistant
Fully compatible with autoclave, gamma irradiation, and ethylene oxide (EO) sterilization processes.
Flexible Hardness Range
Available in Shore A 20–70, offering excellent elasticity, tear resistance, and compression recovery.
Versatile Processing
Designed for extrusion, compression molding, and precision-formed medical components.
Custom Colors & Formulation
Custom hardness and color options available for product identification and application-specific needs.
Long-Term Performance
Reliable mechanical and chemical stability for long-term medical and pharmaceutical use.
Medical Grade HTV Silicone - Technical Data
| Code | Hardness | Tensile (MPa) | Elongation (%) | Tear strength (N/mm) |
|---|---|---|---|---|
| HTVWIC-70 A/B | 70 | |||
| HTVWIC- 65 A/B | 65 | 8.25 | 853 | 45.5 |
| HTVWIC- 53 A/B | 53 | 6.6 | 852 | 41.3 |
| HTVWIC- 45 A/B | 45 | 7 | 825 | 32.2 |
| HTVWIC- 40 A/B | 40 | 7 | 841 | 22.2 |
| HTVWIC- 35 A/B | 35 | 5.5 | 834 | 25 |
| HTVWIC- 30 A/B | 30 | 2.4 | 547 | 9.4 |
Note: * Formulations can be customized to meet your precise technical specifications, including desired physical and chemical properties.
Typical Applications
Medical Tubing & Catheters
Safe, flexible, and fully body-contact approved for tubes, catheters, and fluid transfer systems.
Device Seals & Gaskets
Leak-proof and durable under medical sterilization conditions, ideal for pumps, valves, and diagnostic devices.
Surgical Handles & Grips
Heat-sterilizable, ergonomic, and comfortable for repeated clinical use.
Implantables & PPE
Chemically inert and durable under sterilization; suitable for PPE components, implants, and wearable devices.
Pharma Packaging & Lab Parts
Non-reactive in pumps, valves, containers, and laboratory equipment, maintaining purity and chemical stability.
Medical Device Grommets & Bushings
Flexible sealing solutions for tubing entries, connectors, and device housings.
Patient Contact Surfaces
Smooth, soft, and biocompatible surfaces for medical devices in direct patient contact.
Diagnostic & Laboratory Components
Precise, chemical-resistant parts for analyzers, test kits, and lab automation equipment.
Compliance & Quality
- ISO 9001 – Quality Management
- Meets FDA standards –ensuring safety and reliability.
- ISO 10993-4: Tests for blood-material interactions.
- ISO 10993-10: Evaluation for skin irritation and sensitization.
- ISO 10993-5: In vitro cytotoxicity testing for medical devices.
- Batch-tested for strength & durability
- Fully traceable batch documentation
- ASTM / ISO standards verified
- RoHS / REACH compliant
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