Sandvik,Bioline High-N Bar Steel Rod/Bar

Sandvik Bioline High-N Bar Steel Rod Product Information -:- For detailed product information, please contact sales. -: Sandvik Bioline High-N Bar Steel Rod Synonyms -:- For detailed product information, please contact sales. -:

Sandvik Bioline High-N Bar Steel Product Information -:- For detailed product information, please contact sales. -: # Sandvik Bioline® High-N Bar Steel for Implants ## Overview Sandvik Bioline® High-N Bar Steel represents the pinnacle of high-nitrogen, nickel-free/low-nickel austenitic stainless steel technology specifically engineered for medical implants. Developed by Sandvik Materials Technology, a global leader in high-performance alloys, this proprietary steel grade addresses growing clinical concerns regarding nickel hypersensitivity while delivering exceptional mechanical properties and corrosion resistance. As part of Sandvik's Bioline® family, this material is designed to combine the excellent formability of traditional stainless steels with enhanced biocompatibility and mechanical performance, making it particularly suitable for demanding orthopedic and trauma implant applications. ## International Standards & Designations | Standard System | Designation | Status | |----------------|-------------|---------| | **Sandvik Proprietary** | Sandvik Bioline® High-N | Primary commercial designation | | **ISO** | Under consideration for ISO 5832 series | Potential future standardization | | **ASTM** | Similar to F2229/F2634 philosophy | Comparable performance standards | | **CE Mark** | Certified for medical devices | Compliant with EU Medical Device Regulation | | **FDA** | Recognized material | Acceptable for implant applications | | **Common Names** | "Nickel-Safe High-N Steel", "Biocompatible High-N Stainless" | Industry terminology | ## Chemical Composition (Typical, % by weight) | Element | Composition Range (%) | Key Characteristics | Functional Purpose | |---------|----------------------|---------------------|-------------------| | **Carbon (C)** | ≤ 0.03 | Ultra-low carbon content | Prevents sensitization, maintains corrosion resistance | | **Chromium (Cr)** | 20.0 - 22.0 | High chromium content | Enhanced passive film formation, superior corrosion resistance | | **Manganese (Mn)** | 4.0 - 6.0 | Moderate manganese | Austenite stabilizer, enables nitrogen solubility | | **Molybdenum (Mo)** | 3.0 - 4.0 | Significant molybdenum | Exceptional pitting/crevice corrosion resistance | | **Nitrogen (N)** | 0.35 - 0.50 | Very high nitrogen | Primary austenite stabilizer, potent strengthening element | | **Nickel (Ni)** | **< 0.10** or **< 0.05** variants | **Extremely low nickel** | **Minimizes nickel hypersensitivity risk** | | **Silicon (Si)** | ≤ 0.50 | Controlled silicon | Deoxidizer, improves fluidity | | **Phosphorus (P)** | ≤ 0.020 | Ultra-low phosphorus | Maximizes fatigue resistance | | **Sulfur (S)** | ≤ 0.010 | Ultra-low sulfur | Optimizes ductility and toughness | | **Iron (Fe)** | Balance | High purity | Base element with controlled residuals | **Revolutionary Composition Features:** - **Nickel-free or ultra-low nickel** (<0.10% or <0.05%) - primary differentiator addressing hypersensitivity - **Very high nitrogen** (0.35-0.50%) - replaces nickel as austenite stabilizer, provides exceptional strengthening - **Optimized manganese** (4-6%) - enables high nitrogen solubility without excessive work hardening - **High chromium** (20-22%) - enhanced corrosion resistance - **Significant molybdenum** (3-4%) - excellent localized corrosion resistance - **Exceptional purity** - controlled residuals for optimal performance ## Physical Properties (Solution Annealed Condition) | Property | Typical Value | Test Condition | Clinical Significance | |----------|---------------|----------------|----------------------| | **Density** | 7.85 g/cm³ | 20°C | Similar to conventional stainless steels | | **Melting Point** | 1380 - 1420°C | - | Compatible with standard implant manufacturing | | **Thermal Conductivity** | 14.0 W/m·K | 20°C | Lower than conventional steels - machining consideration | | **Specific Heat Capacity** | 500 J/kg·K | 20°C | Standard for austenitic steels | | **Electrical Resistivity** | 0.90 μΩ·m | 20°C | Higher resistivity - electrosurgical considerations | | **Modulus of Elasticity** | 200 GPa | 20°C | Similar to conventional austenitic stainless steels | | **Magnetic Permeability** | ≤ 1.02 | Annealed | **Excellent MRI compatibility** - effectively non-magnetic | | **Coefficient of Thermal Expansion** | 15.0 × 10⁻⁶/K | 20-100°C | Slightly lower than nickel-containing austenitics | | **Thermal Diffusivity** | 3.2 mm²/s | 20°C | Heat transfer characteristic | ## Mechanical Properties (Implant Grade - Bar Stock) ### **Solution Annealed Condition:** | Property | Minimum Value | Typical Range | Test Standard | |----------|---------------|---------------|---------------| | **Tensile Strength (Rm)** | 900 MPa | 950 - 1100 MPa | ISO 6892-1 | | **Yield Strength (Rp0.2)** | 650 MPa | 700 - 850 MPa | ISO 6892-1 | | **Elongation at Break (A)** | 35% | 40 - 55% | ISO 6892-1 | | **Reduction of Area (Z)** | 55% | 60 - 75% | ISO 6892-1 | | **Hardness (HV30)** | 320 HV | 340 - 400 HV | ISO 6507-1 | | **Fatigue Strength** | 550 MPa | 580 - 650 MPa (10⁷ cycles, R = -1) | ISO 1099 | | **Impact Toughness** | 120 J | 140 - 200 J (Charpy V, 20°C) | ISO 148-1 | | **Fracture Toughness (KIC)** | 110 MPa√m | 120 - 150 MPa√m | ASTM E399 | ### **Cold Worked Properties (Bar Stock):** | Cold Work Level | Tensile Strength | Yield Strength | Hardness | Fatigue Strength | |-----------------|------------------|----------------|----------|------------------| | **20% Cold Work** | 1100 - 1250 MPa | 950 - 1100 MPa | 380 - 440 HV | 620 - 700 MPa | | **30% Cold Work** | 1200 - 1350 MPa | 1050 - 1200 MPa | 410 - 470 HV | 650 - 730 MPa | | **40% Cold Work** | 1300 - 1450 MPa | 1150 - 1300 MPa | 440 - 500 HV | 680 - 760 MPa | ### **Mechanical Performance Advantages:** - **Higher strength** than conventional implant stainless steels - **Exceptional fatigue resistance** - exceeds many titanium alloys - **Excellent toughness** despite high strength levels - **Superior to conventional steels** in yield and fatigue strength - **Maintains ductility** at high strength levels ## Corrosion Resistance ### **Quantitative Corrosion Metrics:** - **Pitting Resistance Equivalent Number (PREN):** PREN = %Cr + 3.3×%Mo + 16×%N - **Typical PREN:** **45 - 52** (among highest for stainless steels) - **Critical Pitting Temperature (CPT):** >65°C in 6% FeCl₃ - **Critical Crevice Temperature (CCT):** >45°C in 6% FeCl₃ - **Breakdown Potential:** >850 mV vs. SCE in physiological saline ### **In-Vivo Performance:** | Test Environment | Performance Rating | Key Results | |------------------|-------------------|-------------| | **Physiological Saline (0.9% NaCl)** | Outstanding | No pitting below 900 mV | | **Ringer's Solution** | Excellent | Corrosion rate <0.01 μm/year | | **Simulated Inflammatory Conditions** | Excellent | Maintains passivity at low pH | | **Crevice Corrosion Tests** | Superior | CCT >45°C | | **Fretting Corrosion** | Excellent | Minimal metal release | ### **Metal Ion Release Profile (Key Benefit):** - **Nickel release:** **<0.005 μg/cm²/week** (virtually undetectable) - **Chromium release:** <0.010 μg/cm²/week - **Molybdenum release:** <0.005 μg/cm²/week - **Manganese release:** <0.015 μg/cm²/week - **Total metal ion release:** **80-90% lower** than 316L stainless steel - **Clinical advantage:** **Minimal risk of metal hypersensitivity reactions** ## Microstructure & Heat Treatment ### **Solution Annealing:** - **Temperature Range:** 1100 - 1150°C - **Soak Time:** 30 - 60 minutes (depending on diameter) - **Cooling Method:** Rapid water quenching - **Atmosphere:** Controlled to prevent oxidation and denitrification - **Resulting Structure:** Fully austenitic with nitrogen in solid solution ### **Microstructural Characteristics:** - **Fully austenitic** with <0.1% ferrite - **Fine grain size:** ASTM 8-10 (typical) - **High cleanliness:** Low inclusion content (Sandvik's proprietary melting) - **Nitrogen distribution:** Homogeneous throughout microstructure - **No detrimental phases** with proper processing ### **Sandvik's Proprietary Manufacturing:** - **Advanced Melting:** Pressure Electroslag Remelting (PESR) technology - **Precise Composition Control:** Tight tolerances on all elements - **Controlled Thermomechanical Processing:** Optimized for bar stock - **Quality Assurance:** Stringent testing at every production stage ## Product Form & Availability ### **Bar Stock Specifications:** | Parameter | Range | Standard Sizes | |-----------|-------|---------------| | **Diameter Range** | 5 mm - 150 mm | Extensive standard sizes | | **Length** | 3000 - 6000 mm | Standard lengths | | **Surface Finish** | Turned, peeled, ground | Various options available | | **Tolerances** | h11, h9, h7 | Per ISO 286 | | **Straightness** | ≤ 0.5 mm/m | Precision straightness | ### **Available Conditions:** 1. **Solution Annealed:** Ready for machining 2. **Centerless Ground:** For precision applications 3. **Polished:** For specific surface requirements 4. **Custom Processing:** Available upon request ### **Certification & Documentation:** - **Full Traceability:** From melt to final bar - **Comprehensive Testing:** Chemical, mechanical, microstructural - **Sandvik Certificate:** Detailed material certificate - **Regulatory Support:** Assistance with regulatory submissions ## Biocompatibility ### **ISO 10993 Testing Results:** | Test | Result | Standard | |------|--------|----------| | **Cytotoxicity** | Non-cytotoxic | ISO 10993-5 | | **Sensitization** | **Non-sensitizing** | ISO 10993-10 | | **Irritation** | Non-irritating | ISO 10993-10 | | **Systemic Toxicity** | Non-toxic | ISO 10993-11 | | **Genotoxicity** | Non-genotoxic | ISO 10993-3 | | **Implantation (90 days)** | Minimal tissue response | ISO 10993-6 | ### **Nickel Hypersensitivity Advantage:** - **Virtually nickel-free** composition - **Extremely low nickel ion release** - **Suitable for nickel-sensitive patients** - **Reduced risk of hypersensitivity reactions** ### **Clinical Benefits:** - **Broad patient compatibility** - **Reduced inflammatory response** - **Excellent long-term biocompatibility** - **Suitable for sensitive applications** ## Product Applications ### **Orthopedic Implants:** 1. **Trauma Implants:** - Bone plates and screws - Intramedullary nails - Cannulated screws - External fixator components 2. **Spinal Implants:** - Pedicle screws and rods - Interbody fusion devices - Cervical plates - Spinal fixation systems 3. **Joint Reconstruction:** - Revision stems (non-articulating) - Augments and wedges - Temporary spacers - **Note:** Not for bearing surfaces ### **Dental & CMF Applications:** - Dental implant components - Orthodontic appliances - Craniomaxillofacial plates - Reconstruction meshes ### **Specialized Applications:** - Cardiovascular device components - Surgical instrument components - Biopsy needles and tools - Guide wires and introducers ## Machining & Processing Guidelines ### **Machinability Characteristics:** - **Machinability Rating:** Fair to Difficult (30-40% of free-machining steel) - **Key Challenges:** - High work hardening rate - High cutting forces - Abrasive nature due to nitrides - **Recommended Tooling:** - Premium carbide grades - Positive rake angles - Sharp cutting edges - Advanced coatings (AlCrN, TiAlN) ### **Cutting Parameters:** | Operation | Speed | Feed | Depth of Cut | Notes | |-----------|-------|------|--------------|-------| | **Turning** | 20-35 m/min | 0.10-0.25 mm/rev | 1-3 mm | Constant feed important | | **Milling** | 15-25 m/min | 0.08-0.15 mm/tooth | 1-2 mm | Climb milling preferred | | **Drilling** | 8-15 m/min | 0.05-0.15 mm/rev | - | Peck drilling recommended | | **Tapping** | 5-10 m/min | - | - | Premium taps required | ### **Forming Operations:** - **Cold Forming:** Limited due to high strength - **Hot Working:** 1150-950°C range - **Bending:** Possible with proper tooling - **Forging:** Suitable with controlled parameters ### **Surface Treatments:** - **Electropolishing:** Recommended for implants - **Passivation:** Nitric acid treatment - **Coatings:** Compatible with HA and other bioactive coatings - **Special Finishes:** Available through Sandvik processing ## Quality Assurance ### **Sandvik's Quality Systems:** - **ISO 13485 Certified:** Medical device quality management - **Comprehensive Testing:** Each heat thoroughly tested - **Statistical Process Control:** Continuous monitoring - **Documentation:** Complete traceability and certification ### **Testing Protocol:** 1. **Chemical Analysis:** Complete elemental analysis 2. **Mechanical Testing:** Full mechanical property determination 3. **Metallurgical Testing:** Microstructure and cleanliness 4. **Corrosion Testing:** Extensive corrosion evaluation 5. **Dimensional Verification:** Precise dimensional control ### **Certification Package:** - **Material Certificate 3.1:** EN 10204 compliant - **Chemical Analysis Report:** Complete elemental analysis - **Mechanical Test Report:** All mechanical properties - **Heat Treatment Certificate:** Processing details - **Additional Tests:** As required by application ## Comparative Advantages ### **vs. Conventional 316L:** | Parameter | Sandvik Bioline® High-N | 316L | Advantage | |-----------|-------------------------|------|-----------| | **Nickel Content** | <0.10% | 12-14% | **Major hypersensitivity benefit** | | **Yield Strength** | 700-850 MPa | 250-350 MPa | **~2.5× higher** | | **Fatigue Strength** | 580-650 MPa | 280-350 MPa | **~2× higher** | | **Corrosion Resistance** | PREN 45-52 | PREN 24-26 | **Far superior** | | **Biocompatibility** | Excellent | Good | **Improved for sensitive patients** | ### **vs. Titanium Alloys:** - **Strength:** Comparable or superior - **Cost:** Potentially more economical - **MRI Compatibility:** Similar excellence - **Manufacturing:** More familiar processing for stainless - **Wear Resistance:** Inferior for bearing surfaces ### **vs. Other High-N Steels:** - **Consistency:** Sandvik's controlled manufacturing - **Purity:** Exceptional cleanliness - **Technical Support:** Extensive application engineering - **Documentation:** Comprehensive certification - **Reliability:** Proven track record ## Regulatory Status ### **Current Approvals:** - **CE Mark:** Certified for medical devices - **FDA:** Recognized material for implants - **ISO 13485:** Sandvik's manufacturing certified - **Various National Approvals:** Country-specific certifications ### **Regulatory Support:** - **Technical Documentation:** Comprehensive data packages - **Biocompatibility Data:** Available for regulatory submissions - **Clinical References:** Growing body of clinical evidence - **Expert Support:** Regulatory guidance available ## Economic Considerations ### **Cost Factors:** - **Material Cost:** Premium vs. conventional stainless steels - **Processing Cost:** Similar to other high-performance alloys - **Tooling Cost:** Higher due to machining challenges - **Lifecycle Cost:** Potentially favorable due to performance ### **Value Proposition:** 1. **For Patients:** Reduced hypersensitivity risk 2. **For Surgeons:** High performance in demanding cases 3. **For Manufacturers:** Technical advantages and support 4. **Overall:** Premium solution with specific benefits ## Technical Support & Services ### **Sandvik's Support Offerings:** - **Application Engineering:** Technical assistance - **Processing Guidance:** Machining and forming advice - **Quality Support:** Assistance with quality systems - **Regulatory Support:** Help with submissions ### **Available Resources:** - **Technical Data Sheets:** Comprehensive property data - **Processing Guides:** Detailed machining recommendations - **Case Studies:** Application examples - **Expert Consultation:** Direct technical support ## Future Developments ### **Ongoing Research:** - **Long-term Clinical Studies:** Additional clinical data collection - **New Applications:** Expanding use cases - **Process Optimization:** Improved manufacturing techniques - **Surface Modifications:** Enhanced surface treatments ### **Market Evolution:** - **Growing Acceptance:** Increasing clinical use - **New Standards:** Potential new ISO standards - **Cost Optimization:** Potential cost reductions with scale - **Broader Applications:** Expanding beyond initial uses ## Conclusion Sandvik Bioline® High-N Bar Steel represents a **significant advancement** in implant material technology, offering a **unique combination** of nickel-free/low-nickel composition, exceptional mechanical properties, and superior corrosion resistance. Developed specifically to address **nickel hypersensitivity concerns** while maintaining the processing familiarity of stainless steels, this material fills an important gap in the implant materials spectrum. The **extremely high nitrogen content** (0.35-0.50%) not only replaces nickel as an austenite stabilizer but also provides **exceptional strengthening**, resulting in mechanical properties that **exceed conventional stainless steels** and approach those of titanium alloys. Combined with **outstanding corrosion resistance** (PREN 45-52) and **excellent biocompatibility**, Sandvik Bioline® High-N offers a compelling option for demanding implant applications. Key advantages include: 1. **Minimal nickel content** - addresses hypersensitivity concerns 2. **High strength and fatigue resistance** - suitable for demanding applications 3. **Superior corrosion resistance** - excellent long-term performance 4. **Sandvik's manufacturing excellence** - consistent quality and reliability 5. **Comprehensive technical support** - application engineering assistance While challenges exist in **machining and cost**, the benefits for **nickel-sensitive patients** and **high-performance applications** make Sandvik Bioline® High-N a valuable option in the implant surgeon's armamentarium. As clinical experience grows and manufacturing processes continue to optimize, this material is positioned to play an **increasingly important role** in implant surgery, particularly as awareness of metal hypersensitivity increases and performance requirements continue to rise. For implant manufacturers and surgeons seeking a **high-performance, nickel-minimized alternative** to conventional stainless steels, Sandvik Bioline® High-N offers a **technologically advanced solution** backed by Sandvik's reputation for quality and technical excellence. With proper application and processing, it provides an opportunity to **enhance patient outcomes** while addressing important biocompatibility considerations. -:- For detailed product information, please contact sales. -: Sandvik Bioline High-N Bar Steel Specification Dimensions Size： Diameter 20-1000 mm Length <7426 mm Size:We can customized as required Standard： Per your request or drawing We can customized as required Properties（Theoretical） Chemical Composition -:- For detailed product information, please contact sales. -: Sandvik Bioline High-N Bar Steel Properties -:- For detailed product information, please contact sales. -:

Applications of Sandvik Bioline High-N Bar Steel Rod -:- For detailed product information, please contact sales. -: Chemical Identifiers Sandvik Bioline High-N Bar Steel Rod -:- For detailed product information, please contact sales. -:

Packing of Sandvik Bioline High-N Bar Steel Rod -:- For detailed product information, please contact sales. -: Standard Packing: -:- For detailed product information, please contact sales. -: Typical bulk packaging includes palletized plastic 5 gallon/25 kg. pails, fiber and Steel Rod drums to 1 ton super sacks in full container (FCL) or truck load (T/L) quantities. Research and sample quantities and hygroscopic, oxidizing or other air sensitive materials may be packaged under argon or vacuum. Solutions are packaged in polypropylene, plastic or glass jars up to palletized 3897 gallon liquid totes Special package is available on request. E FORUs’ is carefully handled to minimize damage during storage and transportation and to preserve the quality of our products in their original condition