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TPEE Medical Catheter Material
An ultra-pure, high-performance TPEE material that meets the highest regulatory standards for medical devices.
Category:
- Product Description
- 概要
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Item
Description
Product Name
Medical Catheter Grade Thermoplastic Polyester Elastomer
Product Description
An ultra-pure, high-performance TPEE material that meets the highest regulatory standards for medical devices.
Key Characteristics
1. Comprehensive Biocompatibility & Safety: Passes full suite of ISO 10993 biocompatibility evaluations (cytotoxicity, sensitization, irritation, systemic toxicity, etc.) and complies with USP Class VI, ensuring safety for human contact.
2. Ultra-Low Extractables/Leachables: Formulation is strictly controlled to ensure minimal种类 and concentration of chemical substances migrating under simulated clinical conditions, meeting pharmacopeia and regulatory requirements.
3. Broad Sterilization Compatibility: Resistant to various terminal sterilization methods including Gamma Radiation, Ethylene Oxide (EO), E-beam, and Autoclaving, with stable post-sterilization performance.Main Applications
(Note: Fundamentally different from the original image application.) E.g., peripheral & neurovascular catheters, central venous catheters, balloon catheter shafts, microcatheters, drainage tubes, specialized infusion lines.
Processing Method
Precision Extrusion (single or multi-layer co-extrusion), Injection Molding (for hubs, etc.). Must be processed in an ISO Class 7 or higher cleanroom.
Key Certs/Standards
Biocompatibility: ISO 10993 series, USP Class VI; Quality System: ISO 13485; Regulatory: Compliant with relevant FDA, CE MDR/IVDR requirements; Environmental: RoHS, REACH.
Color
Typically natural (clear/translucent). Can be colored using medically approved, biocompatibility-tested masterbatches.
Appearance
Ultra-clean, uniform pellets free of visible contaminants.
Packaging
20/25 kg/bag
Physical Properties (Typical Example)
Property
Typical Value/Example
Unit
Test Standard
Specific Gravity
1.15 - 1.25
g/cm³
ASTM D792
Hardness (Shore D)
35D - 55D (common for catheter shafts)
Shore D
ASTM D2240
Tensile Strength
≥ 30
MPa
ASTM D412
Elongation at Break
300 - 500
%
ASTM D412
Key Medical Attributes
Passes ISO 10993-5 Cytotoxicity Test
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ISO 10993-5
Processing Reference
Thorough drying is MANDATORY: 4-6 hours at 120-125°C in a dehumidifying dryer to moisture content <0.02%. Melt Temperature: 200-230°C. All processing equipment must be dedicated and cleaned/validated.
Key Notes & Disclaimer
Final Validation Responsibility: The medical device manufacturer (OEM) bears full responsibility for conducting a comprehensive biological safety evaluation, extractables/leachables study, sterilization validation, and preclinical testing based on their final product's specific design, intended use, nature, and duration of contact.
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Guangdong Jinyuan Plastic Technology Co., Ltd.
Building 13, Zone C, Wanyang Innovation Hub, Yangqiao Town, Boluo County, Huizhou City, Guangdong Province, China
