
ISO Certified Medical Titanium Wire
Standard:ISO5832-3, ASTM F136/F67
Diameter:0.1-4mm
Tensile strength:>1080MPa
Shape:Straight wire/Spool Wire
Characteristic:Surface roughness≤0.8µm
Application:Kirschner wire, elastic intramedullary nail
Certificates:Test report, Third party test report
As a long-established source manufacturer in the medical titanium field, Shaanxi Chenxin Titanium specializes in the R&D, production, and foreign trade supply of ISO-certified medical titanium wires. Our products strictly adhere to American standards and ISO 13485 medical device quality management system certifications. With outstanding biocompatibility, precise dimensional control, and flexible customization capabilities, we have become a preferred partner for the medical industry in Europe and America. Medical titanium wires, as a core consumable for medical devices, are widely used in high-end medical fields such as orthopedics, dentistry, and cardiovascular applications. We consistently prioritize "medical-grade safety, industrialized mass production, and personalized adaptation," providing global clients with high-purity, high-performance medical titanium wire solutions. Supported by a comprehensive after-sales system, we ensure efficient delivery and user experience for foreign trade orders throughout the entire process.
1. Core Advantages of Medical Titanium Wire (Empowered by ISO Certification)
ISO certification is the key gate to medical grade titanium wire into the global healthcare industry, providing strong safety and quality assurance for our products. All our products are passed ISO 13485 certification and testing based on related standards of ASTM, our titanium purity is over 99.95% with the impurities are tightly confined in the range of medical grade.
They exhibit excellent biocompatibility-no rejection reactions with human tissues, enabling long-term implantation while maintaining outstanding corrosion resistance to resist bodily fluids, ensuring structural stability and service life of implanted devices. Compared to conventional titanium wire, ISO-certified medical-grade titanium wire achieves full-process traceability during production-from raw material procurement, melting, drawing, to finished product inspection-each step meticulously documented to meet the stringent compliance requirements of European and American healthcare clients. Additionally, it possesses a balanced combination of high strength and low modulus, making it suitable for various medical device molding and application needs.
In practical applications, the advantages of ISO-certified medical titanium wire become further evident, precisely meeting the specific needs of various medical fields. It is widely used in orthopedics, where its strength meets the load-bearing requirements of fracture fixation devices, and the low modulus of elasticity reduces mechanical incompatibility with human bones and diminishes the risk of developing postoperative complications.
In dentistry, its biocompatibility facilitates intimate contact between the wire and gum tissue without inciting inflammation, and the surface can also be modified through oxidation to increase bonding to teeth. In cardiovascular applications, high purity and tight dimensional tolerances allow titanium wire to be conductive and flexible in devices such as stents and catheters, while meeting the demands of minimally invasive procedures. The generality of ISO certification also means that the product can be marketed in the mainstream European and American markets directly without other testing of compliance, which greatly shortens the cycle for product launching and enhances the efficiency for foreign trade cooperation.
2. Characteristics and Application Scenarios of American Standard Grades (with Dimension Parameter Table)
|
ASTM Grade |
Alloy Composition |
Diameter Range (mm) |
Tensile Strength (MPa) |
Application Scenarios |
Surface Treatment |
|---|---|---|---|---|---|
|
ASTM F136 Gr5 ELI |
Ti-6Al-4V ELI |
0.1-5.0 (Customizable up to 10.0mm) |
≥860 |
Orthopedic implants (bone screws, plates, pins), spinal fixation devices, trauma instruments |
Anodizing, passivation, sandblasting |
|
ASTM F67 Gr2 |
Commercially Pure Titanium (CP Ti) |
0.05-3.0 (Customizable up to 8.0mm) |
≥345 |
Dental braces, dental implants abutments, surgical sutures, soft tissue fixators |
Electropolishing, natural oxidation |
|
ASTM F1295 Gr4 |
Commercially Pure Titanium (CP Ti) |
0.1-4.0 (Customizable up to 9.0mm) |
≥550 |
Cardiovascular stents, catheters, guide wires, minimally invasive surgical instruments |
Passivation, electrolytic polishing |
|
ASTM F2063 Gr23 |
Ti-6Al-4V ELI (Beta Annealed) |
0.2-6.0 (Customizable up to 12.0mm) |
≥900 |
High-strength orthopedic implants, joint replacements, trauma fixation devices |
Anodizing, acid pickling |
We focus on the demand of the European and American markets, specializing in U.S. medical-grade titanium wire standards, including mainstream models such as ASTM F136 Gr5 ELI, ASTM F67 Gr2, and ASTM F1295 Gr4. Each grade is optimized for specific medical applications, while offering full-size customization to precisely meet the requirements of medical device production. Below are the characteristics, corresponding application scenarios, and standard dimensional parameters for each grade, with adjustments available upon special request
All grades of titanium wire offer tailored dimensional accuracy, diameter tolerances is able to be controlled within ±0.001mm, and length can be customized in cutting (maximum up to 5000mm in one continuous length). Mechanical properties maybe further optimized to meet customer specific requirements, e.g. Tensile Strength, Elongation and other parameters to meet designed values for specialized medical device. Also, surface finish processes can be customized - anodized (for color coded customization), electropolishing (to improve surface smoothness and reduce bacterial adhesion), passivated (to increase corrosion resistance) and more, so your product will meet the requirements of any application in the medical industry.
III. Manufacturer's Core Advantages (ISO Certification + Customization and After-Sales Support)
As a world-class producer of titanium materials, our comprehensive industrial chain layout, ISO certification, and expertise in foreign trade allow us to create superior differentiated competitiveness that is worthy enough to serve the global clientele. In customized service and after sales service especially, we have formed the core competitive barrier that helps clients to reduce cost, improve efficiency and seize market opportunity.
Why choose us?
1. Full-dimensional customization capability, precisely matching foreign trade demands. Leveraging our proprietary smelting, drawing, and testing production lines, we can achieve end-to-end customization from grade, dimensions, mechanical properties to surface treatment. For the personalized needs of European and American medical clients, we offer small-batch trial production (minimum order quantity of 50kg) and large-scale mass production services, while also supporting customized development based on client drawings or samples. Dimensional tolerances and performance parameters can strictly align with client standards. During the customization process, a dedicated technical team provides full-process support, ensuring synchronized progress with clients at every stage-from design planning and sample prototyping to mass production. This guarantees high alignment between customized products and requirements. Additionally, with ISO system controls, customized products can achieve compliance traceability without additional inspection costs, significantly shortening foreign trade order delivery cycles.
2. Comprehensive foreign trade after-sales service, ensuring full support for order fulfillment. Tailored to the characteristics of foreign trade, we have established a full-chain service system covering "pre-sales consultation, mid-sales follow-up, and post-sales support." Pre-sales services include providing product compliance documents (ISO certification certificates, U.S. standards inspection reports, origin certificates) and assisting clients in completing local market access registrations. During mid-sales, we synchronize production progress and logistics information in real time, utilizing moisture-proof and oxidation-resistant packaging alongside diversified logistics solutions such as sea and air freight to ensure safe delivery of products. As a world-class producer of titanium materials, our comprehensive industrial chain layout, ISO certification, and expertise in foreign trade allow us to create superior differentiated competitiveness that is worthy enough to serve the global clientele. In customized service and after sales service especially, we have formed the core competitive barrier that helps clients to reduce cost, improve efficiency and seize market opportunity.
3. Large-scale production and cost advantages enhance customer profitability. We operate a medical titanium wire production line with an annual capacity of 500 tons. Leveraging the abundant titanium resources in Shaanxi, we achieve self-sufficient raw material procurement and smelting, reducing intermediate costs and offering competitive export quotations to clients. Through automated production equipment and ISO-certified quality control, we maintain a product pass rate of over 99.8%, minimizing losses from quality-related issues. For long-term partners, we provide volume discount policies and inventory storage services, enabling flexible supply adjustments based on order requirements to ensure production continuity. After years of exporting experience, we fully understand tariffs, trade barriers and other regulations in European and American markets, assisting clients to reduce trade risks, and improve cooperation stability.
FAQ
1.Customized medical-grade titanium wire delivery cycle? Delivery time depends on the customization. For standard sizes and grades, batch orders up to 500kg can be fulfilled in 15-20 working days, including production and testing. For special performance or high-accuracy dimensional customization, you will need an additional 3 to 5 workdays for process adjustments and sample confirmation. For export orders, the total delivery cycle contains the time for restock and the time for logistics and custom clearance. Orders are processed and tracked in real-time to provide customers with full control during the order process, in which we make sure that the orders arrive on schedule which we deliver with confidence.
2. Does the customized product have compliance test reports? Yes, all custom medical titanium wires are accompanied by a full set of compliance paperwork including ISO 13485 certifications, ASTM standard test reports (containing composition, mechanical properties and biocompatibility testing), certificates of origin, and product traceability reports. If there are further requirement for testing, we can help connect with 3rd party authoritative testing agencies (such as SGS, TÜV) to make sure the product meets local market access requirements.
3. In case of product compatibility issues after-sales, how to resolve them? If product compatibility issues arise after-sales, you can immediately contact our technical support team. We will respond within 24 hours, analyzing the cause of the issue through online communication. If the issue is due to customized parameter deviations, we will arrange free re-production and reshipment, covering all round-trip logistics costs. For customer-related processing craftsmanship issues, we will provide professional technical guidance to assist in optimizing the processing solution, ensuring the product functions properly. Throughout the process, we safeguard customer rights and minimize cooperation risks.
V. Product Application Expansion and Cooperation Philosophy
In addition to the aforementioned core application scenarios, our ISO-certified medical titanium wire can also be extended to fields such as neurosurgery, sports medicine, and ophthalmology, meeting the production needs of medical devices like skull fixation, ligament repair, and artificial lens supports. With profound expertise and technological accumulation in the medical titanium industry, we continue to invest in R&D, optimize production processes, and provide forward-looking customized solutions tailored to medical technology trends, helping clients launch more competitive medical products.
In addition to the core application scenarios mentioned above, our ISO certified medical titanium wire can also be extended to fields such as neurosurgery, sports medicine, ophthalmology, etc., to meet the production needs of medical devices such as skull fixation, ligament repair, and artificial lens stents. With a profound understanding and technological accumulation of the medical titanium industry, we continue to invest in research and development, optimize production processes, and provide customers with forward-looking customized solutions based on the development trend of medical technology, helping customers launch more competitive medical products.
Shaanxi Chenxin Titanium Industry always adheres to the cooperation concept of "quality as the foundation, customer as the center, and compliance as the bottom line", deeply cultivates the European and American medical titanium material market, relies on ISO certification, features customized services, and guarantees perfect after-sales service, providing cost-effective medical titanium wire products and foreign trade services for global medical customers. We welcome various medical device manufacturers and foreign traders to come and negotiate cooperation. We can provide free sample testing, customize exclusive supply solutions, and work together to create a new future of cooperation in the medical field.
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Email:bjcxtitanium@gmail.com
Whatsapp:+8613571718779
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