1. Composition & Purity Standards
Iron Content: ≥99.98% (ultra-low impurities: C ≤0.005%, S ≤0.003%, P ≤0.005%, Mn ≤0.02%).
Certifications: Complies with ASTM F138, ISO 5832-1 for surgical implant standards.
2.Specialized Production Process
1). Vacuum Induction Melting (VIM): Removes gases (O₂ <10 ppm, N₂ <20 ppm) to eliminate toxic impurities.
2). Electroslag Remelting (ESR): Purifies iron using medical-grade slag (CaF₂-Al₂O₃), reducing inclusions to ≤2 µm.
3). Precision Machining: Laser-cut or EDM-finished to ensure smooth, burr-free surfaces (Ra ≤0.2 µm).
3. Unique Properties for Healthcare
|
Feature |
Medical-Grade Iron |
Standard Pure Iron |
|
Biocompatibility |
Passes ISO 10993 cytotoxicity tests |
Untested; potential leaching |
|
MRI Compatibility |
Non-magnetic(cold-worked grades) |
May interfere with imaging |
|
Corrosion Resistance |
Electrochemically optimized for body fluids |
Prone to pitting in saline |
4. Applications & Advantages
Primary Medical Uses
- Orthopedic Implants: Bone screws, plates, and pins with controlled degradation.Tensile strength 350–450 MPa, matching human bone.
- Surgical Instruments: Non-sparking, MRI-safe scalpels and clamps (autoclavable).
- Cost Efficiency: 30% lighter than titanium, reducing surgical costs.
- Cardiovascular Stents: Biodegradable iron stents for artery support. Predictable absorption rate (1–2 years post-implantation).
-Diagnostic Devices: MRI-compatible components (non-magnetic interference). Zero cytotoxicity (ISO 10993-5 certified).
-Processable: Easily machined, welded, or 3D-printed.
-Sustainable: 100% recyclable with zero loss of mechanical properties.
5.Quality Assurance & Certifications
-Testing: Cytotoxicity (ISO 10993-5), corrosion (ASTM G61), and fatigue testing (ISO 14801).
-Certifications: ISO 13485 (medical devices), ASTM F138 (implantable iron), FDA 510(k) clearance.
-Traceability: RFID-tracked batches with full material disclosure (FMD) reports.
If you need anything, please contact us now.
📫：sales3@beilunmetal.com
📞：8619335134327
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