Biocompatible Titanium Wire

Biocompatible Titanium Wire

Alloy Grade Ti-6Al-4V ELI (Grade 5 ELI)
Standard ASTM F136 / ISO 5832-3
Diameter Range 0.5 mm – 3.0 mm
Tensile Strength ≥ 860 MPa (annealed)
Elongation ≥ 10%
Hardness 25–35 HRC
Surface Finish Polished / Bright / Pickled
Condition Annealed or Cold Drawn
Coil Type Precision wound coil, straightened on request
Certification Mill Test Certificate, EN 10204 3.1
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Product Introduction

Biocompatible Titanium Wire (Med Grade Core Wires for Implants and IVDS) Description of Biocompatible Titanium Wire A medical grade biocompatible titanium wire designed for contact with the human body applications.

Physical Properties Tensile Strength yield Strength Elongation Section Shrinkage
Unit Mpa Mpa % %
Ti-6AL4V >930 >860 >10 >25
Ti-6AL4VELI >860 >795 >10 >25

 

Chemical Composition:

Type Chemical Composition (wt%)
Al V Fe C N H O
Ti-6AL4V 5.5-6.75 3.5-4.5 0.3 0.08 0.05 0.008 0.2
Ti-6AL4VELI 5.5-6.5 3.5-4.5 0.25 0.08 0.03 0.012 0.13
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Biocompatible Titanium Wire

With ultimate biocompatibility as its core, it fully complies with international medical standards such as ASTM F67 and ISO 5832-1. It is widely used in global orthopedic implants, cardiovascular minimally invasive procedures, and dental instruments. As a critical material directly in contact with human tissues or body fluids, it adheres to stringent medical-grade requirements from raw material purity to production processes, perfectly balancing "biological safety + mechanical performance + formability." It serves as the foundational material for high-end medical device manufacturing and is highly recognized by global medical equipment manufacturers.

The dimensional parameters of biocompatible titanium wires are precisely tailored to meet the refined requirements of medical applications. Standard diameters range from 0.01mm to 3.0mm, with customizable ultra-fine specifications (≤0.1mm, for cardiac stent guidewires and neural stimulation electrode wires) and coarse specifications (5.0mm, for orthopedic fixation pins and dental implant auxiliary wires). Diameter tolerances are strictly controlled according to specifications: ±0.001mm for ultra-fine (≤0.1mm) and ±0.01mm for medium-coarse (>0.1mm), ensuring operational precision of minimally invasive surgical instruments and compatibility with implants. Surface treatments prioritize "low irritation and high biocompatibility," offering mirror polishing (Ra≤0.2μm to reduce tissue friction damage) and acid pickling passivation (removal of oxide layers and impurities to avoid sensitization risks). The entire series passes biocompatibility tests including cytotoxicity, sensitization, and hemolysis assessments, meeting medical implant-grade certifications from the FDA (USA), CE (EU), and NMPA (China).

 

The selection of biocompatible titanium wire grades focuses on "biological safety and performance compatibility." The mainstream grades include GR1 pure titanium, GR2 pure titanium, and GR9 low-alloy titanium. GR1 pure titanium has a titanium purity of  ≥99.5% with very little harmful impurities like iron, oxygen, etc., attaining "long-term implantation grade" biocompatibility and extremely high resistance in body fluid, and thus can be used as artificial joint fixation wire and orthopedic suture and the like which is intended to be left in the human body for a long time. GR2 pure titanium wire has a moderate strength (tensile strength: 345-450 MPa) which is higher than that of GR1 with good formability, it is applicable for reusable surgical instruments (notably laparoscopic graspers) and limited term implantable medical parts. GR9 (Ti-3Al-2.5V) low alloy titanium wire offers superior strength and flexibility which means it can be formed into intricate shapes, this property of the wire makes it ideal for use in cardiovascular catheter guidewires as well as orthodontic haswires which need to be bent regularly and offer some level of support.

The core advantage of biocompatible titanium wire is its precise matching of pain points in medical scenarios. Its biocompatibility has been clinically tested and proven it is non allergenic, non toxic and will not induce any rejection responses inside the human body. In addition, it may establish a stable interface with human bone tissue, making use of long term implantation safe. In the environment of human body fluids (pH=7.2-7.4), a dense oxide film will form on the surface, which will not corrode or dissolve metal ions after long-term immersion. The service life can reach more than 10 years, meeting the long-term service requirements of implanted devices. Mechanical properties are suitable for medical use, with an elongation rate of ≥ 18% (pure titanium grade). It can achieve ultra-fine drawing and complex winding forming, which not only meets the strength requirements of orthopedic fixation, but also adapts to the flexible operation of minimally invasive surgical instruments, balancing reliability and convenience of use.

In terms of quality and service assurance, each batch of biocompatible titanium wires has undergone laser diameter calibration, tensile testing, electrochemical corrosion testing, and a full set of biocompatibility testing. A complete COA analysis report, DMF filing information, and clinical application cases can be provided. Support small batch customization (minimum order quantity 0.1kg) and fixed length cutting (accuracy ± 0.5mm) to meet the needs of instrument research and mass production; Adopting vacuum sealing and inert gas packaging (to prevent material oxidation), we cooperate with international medical logistics to provide temperature controlled transportation and customs special supervision clearance services, ensuring compliant and fast delivery of products. If further docking is required, biocompatibility testing reports (cytotoxicity, sensitization test data) or device adaptation plans can be provided to assist customers in promoting product medical certification and marketization.

 

 

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Whatsapp:+8613571718779

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