PMMA Pellets for Medical Device Housings, LX HI-835M, Medical Grade & Gamma Sterilizable
Product Spotlights
As a specialized manufacturer of engineering plastics, Shanghai Wenqin Plastics Co., Ltd. is committed to providing high-performance material solutions for the demanding medical industry. Our LX HI-835M PMMA Pellets are engineered specifically for medical device housings, offering an optimal balance of clarity, durability, and biocompatibility. This medical-grade material is designed to meet the stringent requirements of device manufacturers, ensuring patient safety and device reliability through its gamma sterilization compatibility.
Core Features & Technical Advantages:
- Medical-Grade Purity & Safety: Formulated with high-purity raw materials, LX HI-835M is suitable for applications requiring contact with sensitive environments. Its composition is controlled to minimize extractables and leachables, a critical factor for medical device compliance.
- Superior Optical Clarity & Aesthetics: PMMA is renowned for its glass-like transparency and high gloss finish, making it ideal for device housings where visual inspection of internal components or aesthetic appeal is important.
- Excellent Gamma Radiation Resistance: A key selling point, this grade maintains its mechanical properties, color stability, and clarity after exposure to gamma sterilization doses, ensuring device integrity throughout its lifecycle.
- High Rigidity & Dimensional Stability: Provides the structural integrity needed for protective housings without significant deformation under load or varying environmental conditions.
- Good Chemical Resistance: Resists degradation from many common cleaning agents and disinfectants used in healthcare settings.
- Ease of Processing: The pellet form is optimized for efficient injection molding and extrusion, allowing for high-yield production of complex housing geometries with excellent surface finish.
Technical Specifications & Performance Data:
| Property | Test Method | Typical Value |
|---|---|---|
| Melt Flow Rate (230°C/3.8kg) | ASTM D1238 | 10-15 g/10 min |
| Tensile Strength | ASTM D638 | ≥ 70 MPa |
| Flexural Modulus | ASTM D790 | ≥ [Value available upon request] GPa |
| Izod Impact Strength (Notched) | ASTM D256 | 15-20 J/m |
| Heat Deflection Temp (1.8 MPa) | ASTM D648 | ≥ 90 °C |
| Light Transmittance | ASTM D1003 | ≥ 92% |
| Specific Gravity | ASTM D792 | 1.19 |
Benefits for Your Medical Device Production:
- Regulatory Confidence: Using a material designated as "medical grade" and compatible with terminal sterilization simplifies the material qualification process for your device.
- Enhanced Device Lifespan: Resistance to gamma radiation and chemicals helps maintain the housing's appearance and functionality after repeated sterilization cycles.
- Manufacturing Efficiency: Consistent pellet quality and good flow characteristics can reduce cycle times and scrap rates in injection molding.
- Design Flexibility: The combination of clarity and strength allows designers to create both functional and visually appealing device enclosures.
Shanghai Wenqin Plastics operates a dedicated facility and leverages a robust quality management system, as reflected in our certifications, to ensure every batch of LX HI-835M PMMA Pellets meets precise specifications. Our products are trusted by manufacturers across diverse global markets, including North America, Europe, and Asia. We understand the critical nature of medical device components and provide material consistency you can rely on. Partner with us to integrate high-performance, sterilizable PMMA into your next medical housing project. Contact our team today for detailed technical data sheets, pricing, and sample requests.
Frequently Asked Questions (FAQ):
-
Q: What makes this PMMA "medical grade"?
A: "Medical grade" indicates the material is manufactured under controlled conditions with high-purity ingredients, has undergone testing for biocompatibility (suitability for medical use), and is intended for applications in medical devices. Specific test reports are available upon request. -
Q: What is the maximum gamma radiation dose this material can withstand?
A: LX HI-835M is formulated for gamma sterilization. The typical maximum recommended dose is customizable based on your process requirements. Please consult with our technical team for guidance specific to your sterilization protocol. -
Q: Can this material be used for implants or long-term bodily contact?
A: No. This grade is specifically designed and tested for medical device housings and enclosures (external applications). It is not intended for implantable devices or prolonged internal contact. -
Q: Is it compatible with other sterilization methods like EtO or autoclave?
A: While optimized for gamma radiation, its compatibility with Ethylene Oxide (EtO) or steam sterilization (autoclave) should be evaluated case-by-case. We can provide material for your validation testing. -
Q: What colors are available?
A> The natural resin is crystal clear. A range of standard and custom colors is available upon request, using medical-grade colorants. -
Q: What are the recommended injection molding parameters?
A: General guidelines include a melt temperature range of 220-250°C and a mold temperature of 60-80°C. Detailed processing guidelines are provided with the material datasheet. -
Q: Do you provide material certifications and test reports?
A: Yes. Certificates of Analysis (CoA) with batch-specific data are provided. Additional compliance documentation can be discussed based on your project needs. -
Q: What is the minimum order quantity (MOQ)?
A: Our MOQ is flexible to accommodate both prototyping and large-scale production needs. Please contact our sales department for specific quantity and packaging details.
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