Precision Titanium Sheets for Medical Devices
Medical titanium sheets refer to titanium and titanium alloy plate products that comply with relevant international or national medical device standards and are intended for implantation in the human body or for direct contact with human tissue. They are typically manufactured from medical-grade commercially pure titanium or titanium alloys through vacuum melting, hot or cold rolling, and precision leveling processes. Medical titanium sheets feature excellent biocompatibility, corrosion resistance, high strength, and good formability, enabling stable long-term use in the human body.
Medical titanium sheets are widely used in orthopedic implants, repair and fixation systems, dental implants, and surgical instrument structures. As a professional manufacturer of medical titanium sheets, we offer a stable supply of multiple medical grades, covering a wide range from thin to medium-thick plates. We provide customized solutions including fixed lengths, surface conditions, and specific mechanical properties. Our products undergo a comprehensive inspection system, including chemical composition analysis, mechanical property testing, ultrasonic testing, metallographic examination, dimensional checks, and surface quality inspections, ensuring that each batch meets high standards of quality consistency, safety, and traceability for medical applications.
Core Selling Points
- Superior Biocompatibility: Safe for direct and long-term contact with human tissue, minimizing adverse reactions and promoting osseointegration.
- Outstanding Corrosion Resistance: Highly resistant to the corrosive effects of bodily fluids, ensuring long-term structural integrity and performance.
- High Strength-to-Weight Ratio: Provides essential mechanical support while being lightweight, closely matching the elastic modulus of bone to reduce stress shielding.
- Excellent Formability & Machinability: Can be precisely formed, cut, and machined into complex geometries required for advanced medical devices and implants.
- Full Traceability & Consistency: Rigorous quality control from raw material to finished product, with full documentation and batch traceability for every shipment.
- Customized Solutions: Tailored thicknesses, dimensions, surface finishes (e.g., cold rolled, polished, finished), and mechanical properties to meet specific application needs.
JH's Medical Titanium Sheet Products
Detailed Technical Specifications
| ASTM Grade | Standard | Typical Size Range (Thickness × Width, mm) | Typical Mechanical Properties* | Surface Condition | Main Applications |
|---|---|---|---|---|---|
| Grade 1 (CP Ti) | ASTM F67 Gr.1 | T0.5 – 6.0 × W ≤1000 |
Tensile Strength ≥240 MPa Yield Strength ≥170 MPa Elongation ≥24% |
Cold Rolled / Polished | Non-load-bearing implants, medical device structures |
| Grade 2 (CP Ti) | ASTM F67 Gr.2 | T0.5 – 10.0 × W ≤1200 |
Tensile Strength ≥345 MPa Yield Strength ≥275 MPa Elongation ≥20% |
Cold Rolled / Polished | Bone plates, repair plates, surgical instruments |
| Grade 3 (CP Ti) | ASTM F67 Gr.3 | T1.0 – 12.0 × W ≤1200 |
Tensile Strength ≥450 MPa Yield Strength ≥380 MPa Elongation ≥18% |
Hot Rolled / Polished | Medium load-bearing orthopedic implants |
| Grade 4 (CP Ti) | ASTM F67 Gr.4 | T1.0 – 12.0 × W ≤1200 |
Tensile Strength ≥550 MPa Yield Strength ≥485 MPa Elongation ≥15% |
Hot Rolled / Finished | Dental plates, load-bearing fixation systems |
| Grade 5 (Ti-6Al-4V) | ASTM F136 | T1.0 – 20.0 × W ≤1200 |
Tensile Strength ≥860 MPa Yield Strength ≥795 MPa Elongation ≥10% |
Hot Rolled / Finished | High-strength orthopedic implants, joint structures |
| Grade 23 (Ti-6Al-4V ELI) | ASTM F136 ELI | T0.8 – 16.0 × W ≤1200 |
Tensile Strength ≥860 MPa Yield Strength ≥795 MPa Elongation ≥10–15% |
Finished / Polished | Spine systems, joint replacement, long-term implants |
| Ti-6Al-7Nb | ASTM F1295 | T1.0 – 16.0 × W ≤1000 |
Tensile Strength ≥800 MPa Yield Strength ≥700 MPa Elongation ≥10% |
Finished / Polished | High biocompatibility orthopedic and dental implants |
*Note: Typical mechanical properties are for reference only and may vary based on specific processing conditions and product forms. Please refer to the Material Test Certificate (MTC) for actual values.
Quality Certifications & Testing Capabilities
We have established a quality management system that meets the requirements of the medical industry, and the production and quality control of medical titanium sheets are strictly implemented in accordance with relevant international and industry standards. The company has obtained ISO 9001 quality management system certification and has implemented quality control and documentation processes in compliance with ISO 13485 for medical devices, meeting the requirements of medical device customers for quality systems and traceability at the raw material stage [[1]].
In terms of inspection capabilities, we apply full-process quality control to medical titanium sheets. Our inspection scope includes chemical composition analysis, mechanical property testing, ultrasonic non-destructive testing (UT), metallographic examination, as well as dimensional accuracy and surface quality inspections, ensuring stable internal quality and consistent performance in line with the safety and reliability requirements of medical applications [[5]].
Additionally, we have established a comprehensive batch management and quality traceability system. Material Test Certificates (MTCs) and complete inspection reports can be provided with each shipment, offering reliable support for customers’ medical device manufacturing, regulatory registration, and long-term stable supply.
Our Commitment to Quality
- ISO 9001 Certified: Demonstrating our commitment to consistent and reliable quality management.
- ISO 13485 Compliant: Adhering to stringent quality management systems specifically for medical devices.
- Comprehensive Inspection: Full-process quality control from raw material melting to finished product delivery.
- Advanced Testing: Chemical, mechanical, ultrasonic, metallographic, and dimensional checks for guaranteed performance.
- Full Traceability: Batch management and MTCs for complete product history and regulatory compliance.
Application Areas & Case Studies
Medical titanium sheets are widely used in orthopedic implants, repair and fixation systems, dental applications, and surgical instrument components. Orthopedic and spinal implants require strict control over mechanical property stability, uniform plate thickness, and non-destructive testing standards. Dental applications place higher emphasis on precise small-thickness dimensions, surface quality, and machining consistency. Surgical instruments prioritize corrosion resistance and machining stability to withstand repeated sterilization. Cardiovascular-related applications demand higher material cleanliness and precise dimensional control [[2]].
We have long supplied medical titanium sheets to domestic medical device manufacturers as well as customers in Europe and North America, covering applications such as orthopedic implants, dental restorations, and surgical instruments, with stable and continuous supply across multiple grades and specifications. Leveraging a comprehensive quality control system, we provide customized solutions including non-standard thicknesses, fixed-length or short-length deliveries, various surface conditions, and special performance requirements. This ensures consistent quality while maintaining flexible lead times, meeting the medical industry’s high standards for safety and reliability.
Key Application Fields
- Orthopedic Implants: Bone plates, reconstruction plates, intramedullary nails, and joint prostheses.
- Dental Implants & Prosthetics: Custom abutments, frameworks, and restoration components.
- Surgical Instruments: Forceps, retractors, clamps, and other reusable, high-precision tools.
- Cardiovascular Devices: Components for pacemakers, defibrillators, and other implantable electronic devices.
Frequently Asked Questions (FAQ)
A: Medical titanium plates are manufactured strictly according to standards such as ASTM F67 / ASTM F136. Full-process quality control is applied from raw material melting, hot/cold rolling, and precision leveling to finished product delivery. Inspections include chemical composition analysis, mechanical property testing, ultrasonic non-destructive testing, as well as dimensional and surface quality checks, ensuring the products meet medical application requirements.
A: Consistency is ensured through fixed melting batch management, standardized process parameters, and batch-to-batch comparison testing, effectively controlling mechanical properties, plate thickness uniformity, and internal structure, making the products suitable for long-term, continuous supply projects.
A: Precision processing and online dimensional inspection are applied. Plate thickness, length, and width are controlled and visually inspected batch by batch to meet the dimensional tolerance and surface quality requirements of dental, orthopedic, and precision medical device applications.
A: Yes, non-standard thicknesses, fixed-length or short-length deliveries are supported. Mechanical property ranges and surface conditions can also be customized according to application requirements.
A: Surface defects such as scratches, indentations, or cracks are minimized through optimized processing combined with visual inspection and surface condition grading, ensuring safe subsequent processing and use.
A: Common specifications are maintained in reasonable stock, combined with flexible production scheduling. Standard specifications: 2–4 weeks; custom specifications: 4–6 weeks, balancing stable lead time with quality assurance.
A: Material Test Certificates (MTCs), inspection reports, and batch traceability documents can be provided with each shipment, meeting the documentation and compliance requirements of medical customers and regulatory registration projects.