Medical devices, in direct or indirect contact with human blood, mucous membranes, skin, and other tissues, are crucial to human health and safety. As such, the materials used in their production must meet rigorous quality standards and regulatory requirements for safety and stability. Thermoplastic polyurethane (TPU), a high-performance elastomer, has emerged as a promising material in the medical field due to its excellent biocompatibility, wear resistance, heat resistance, chemical resistance, and ease of processing.
TPU’s exceptional properties—robust processing capabilities, superior mechanical performance, and freedom in molecular design—allow for tailored hardness and performance without the need for harmful plasticizers. These characteristics have led to its widespread adoption in the medical device industry. Angreen New Materials has developed a range of medical-grade TPU products, offering specialized material solutions tailored for medical devices.
Angreen’s medical-grade TPU materials are designed to meet the highest international standards, including ISO 9001 and ISO-10993 biocompatibility certification. These materials boast antibacterial properties, chemical and hydrolysis resistance, high transparency, strength, and flexibility—offering a comprehensive solution for the medical device industry.
Hardness Range: Shore A 70 to Shore D 82
Applications:Extruded catheters, injection-molded accessories, cast films
Key Features:
Antimicrobial against Staphylococcus aureus, Escherichia coli, and Candida albicans
Resistant to mold, microbes, chemicals, alcohol, acids, and alkalis
Compatible with gamma ray and ETO sterilization, low drug adsorption, and easy bonding
High transparency, strength, and flexibility; superior to PVC
Complies with RoHS, REACH, ISO 9001, ISO-10993 standards
Halogen-free, environmentally friendly, and non-toxic
Hardness Range:Shore A 75 to Shore D 64
Radiopaque Additives (Barium Sulfate, Tungsten Powder):20% / 40%
Supporting Services:Customized color formulation
Applications:Extrusion catheters, radiopaque devices/accessories
| Properties | Value | Typical value | Unit | Method |
| Hardness （15S|6mm Swatches） | 89±3 | 88 | A | GB/T 2411 |
| Specific Gravity | ≤1.3 | 1.21 | g/cm3 | GB/T 1033 |
| Tensile strength | ≥10.3 | 16 | MPa | GB/T 1040 |
| Tensile elongation | ≥100 | 550 | % | GB/T 1040 |
| Tear strength | ≥20 | 42 | N/mm | CQC1103-2015 Appendix B |
| 110℃*168H TS Retention | ≥70 | 75 | % | GB/T2951.12 |
| 110℃*168H EB Retention | ≥70 | 89 | % | GB/T2951.12 |
| Modulus at 50% | ≥4 | 4.5 | MPa | GB/T 1040 |
| Modulus at 100% | ≥5 | 5.5 | MPa | GB/T 1040 |
| Modulus at 300% | ≥7 | 7.5 | MPa | GB/T 1040 |
| UL Temperature rating | 90 | 90 | ℃ | UL |
| Brittleness Temperature | ≤-40 | ≤-40 | ℃ | GB/T5470 |
| Flame Characteristics | ||||
| LOI | ≥25 | 25 | % | GB/T2406 |
| UL Flame Rating | V0 | Class | UL94 | |
| Electrical Properties | ||||
| VolumeResistivityat20℃ | ≥1.0*1014 | 3.8*1014 | Ω.cm | IEC 60093 |
| Oil Resistance（IRM902,100℃*168H) | ||||
| TS Retention | ≥70 | 83 | % | — |
| EB Retention | ≥70 | 88 | % | — |
| Hot Water Resistance （80℃*168H) | ||||
| TS Retention | ≥70 | 82 | % | — |
| EB Retention | ≥70 | 86 | % | — |
(TPU medical grade material parameter）
1. Biocompatibility:TPU is non-toxic and harmless to human tissues, reducing the risk of rejection or allergic reactions. It’s ideal for producing various medical devices and implants.
2. Antibacterial Properties:With added antibacterial agents, TPU inhibits bacterial growth, helping to control hospital-acquired infections.
3.Flexibility and Elasticity:TPU’s excellent flexibility and elasticity make it suitable for medical products requiring deformation, such as catheters and orthopedic devices, enhancing patient comfort and product durability.
4. Wear and Tear Resistance:TPU's robust wear and tear resistance extends the lifespan of frequently used and disinfected medical equipment, maintaining functionality over time.
5. Chemical Corrosion Resistance:TPU withstands various chemicals, making it suitable for devices requiring regular disinfection, like surgical tools and protective covers.
6. Breathability and Waterproofing:TPU materials provide breathability and waterproofing, ideal for medical protective clothing, dressings, and other versatile supplies.
7.Transparency:Transparent TPU is perfect for devices requiring visual monitoring, allowing direct observation of internal fluid flow or equipment status.
8.Ease of Processing:TPU’s ease of processing supports the manufacture of complex medical device parts, meeting diverse design and functional needs.
The global medical plastics market is experiencing a steady compound annual growth rate of over 6%. However, TPU's application in the medical field faces challenges such as:
Certification Standards:Ensuring compliance with stringent certification standards, including EU MDR, ISO 10993, FDA regulations, and USP Class VI requirements.
Cost-Effectiveness:Balancing performance with cost to meet the budget constraints of the medical industry.
Technological Innovation:As medical technology advances, the demand for higher-performing TPU materials grows, necessitating continuous innovation to meet market needs.
TPU materials, with their versatile advantages, hold significant potential in the medical field. From enhancing existing medical devices to developing new products, TPU offers vast opportunities. However, continuous innovation and stringent quality control are essential to overcoming challenges and driving the future development of TPU in the medical sector.
