Medical Implant Grade Titanium Foil

Medical implant grade titanium foil follows strict technical specifications and quality standards. Its chemical composition must meet the requirements of oxygen content ≤ 0.13%, nitrogen ≤ 0.05%, and hydrogen ≤ 0.012% (tested by ASTM E1941). The mechanical properties require tensile strength ≥ 860MPa, elongation ≥ 10% (tested by ASTM E8/E8M), surface quality to be scratch free and inclusion free, and roughness Ra ≤ 0.4 μ m (ISO 4287 standard). The cleanliness level is controlled to ≤ 5 particles/square meter (certified by ISO 14644-1), fully ensuring the safety and reliability of implant materials.
Compared with ordinary industrial titanium foil, medical implant grade titanium foil has significant advantages: it uses ultra-high purity materials with a purity of over 99.7% and strictly controls impurity elements. It is produced in an ISO 7 cleanroom environment, completely eliminating surface pollutants; Simultaneously providing a complete biological evaluation report and gamma ray sterilization treatment, using medical grade vacuum packaging to ensure that the product is directly applicable to various implantable medical devices, meeting the highest level of biocompatibility and sterility requirements.

Quality assurance system
1. Full process traceability
Provide complete traceability records from sponge titanium raw materials to finished products for each batch of materials, including:

• Smelting furnace number tracking
• Rolling process parameter record
• Heat treatment curve chart

2. Strict testing process

• Chemical Composition Spectral Analysis (OES Detection)
• Metallographic examination (grain size, alpha/beta phase ratio)
• Corrosion Performance Test (ASTM F2129)
• Aseptic testing and pyrogen testing

3. Authentication support

• Provide EU MDR technical document support
• Assist in completing FDA 510 (k) application materials
• Guidelines for Registration and Application of NMPA in China

Clinical application field
1. Orthopedic Implants

• Spinal fusion device coating foil
• Porous surface layer of joint prosthesis
• Bone defect repair scaffold substrate

2. Dental field

• Cervical wrapping foil for dental implants
• Orthodontic archwire reinforcement lining
• Strengthening mesh of denture base

3. Cardiovascular intervention devices

• Encapsulation foil for pacemaker casing
• Vascular stent support layer
• Interventional catheter reinforced braided layer

4. Neurosurgical instrument

• Deep brain stimulation electrode coating
• Skull repair plate lining material
• Neural repair duct enhancement layer

As a local titanium material factory in China, Shaanxi Zhongheng Weichuang Metal Materials Co., Ltd. provides customers with a highly competitive pricing system with the advantages of large-scale production and direct supply chain, ensuring the best cost-effectiveness while ensuring aviation grade quality. All products are packaged in reinforced wooden boxes and efficiently distributed globally through international logistics partners (DHL/FedEx/UPS). The standard delivery time is controlled within 15 working days to ensure safe and timely delivery of goods to all parts of the world.

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