X2CrNi1810 Austenitic Stainless Steel Sheet,Plate,for medical instruments

X2CrNi1810 Austenitic Stainless Steel Sheet/Plate for medical instruments Product Information -:- For detailed product information, please contact sales. -: X2CrNi1810 Austenitic Stainless Steel Sheet/Plate for medical instruments Synonyms -:- For detailed product information, please contact sales. -:

X2CrNi1810 Austenitic Stainless Steel for medical instruments Product Information -:- For detailed product information, please contact sales. -: # X2CrNiMo18-10 (AISI 316L) Austenitic Stainless Steel for Medical Instruments ## Overview X2CrNiMo18-10 (commonly known as AISI 316L or UNS S31603) is a low-carbon, molybdenum-enhanced austenitic stainless steel specifically developed for applications requiring superior corrosion resistance and biocompatibility. As the premier material choice for critical medical applications, it offers exceptional resistance to body fluids, sterilization processes, and chloride-containing environments, making it indispensable for both surgical instruments and implantable medical devices. ## International Standards - **ISO 7153-1:** Surgical instruments – Materials – Part 1: Metals - **ASTM F138/F139:** Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants - **EN ISO 5832-1:** Implants for surgery – Metallic materials – Part 1: Wrought stainless steel - **ASTM A240/A240M:** Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications - **EN 10088-3:** Stainless steels – Part 3: Technical delivery conditions - **UNS S31603:** Unified Numbering System designation - **AISI 316L:** American Iron and Steel Institute designation - **EN 1.4404:** European material number (Note: X2CrNiMo17-12-2 corresponds to 1.4404) - **ISO 3506:** Mechanical properties of corrosion-resistant stainless steel fasteners ## Chemical Composition (Typical, % by weight) | Element | Standard Range (%) | Medical Grade Requirements (%) | |---------|-------------------|--------------------------------| | Carbon (C) | ≤ 0.030 | ≤ 0.030 (max) | | Chromium (Cr) | 16.5–18.5 | 17.0–19.0 | | Nickel (Ni) | 10.0–13.0 | 12.0–14.0 | | Molybdenum (Mo) | 2.0–2.5 | 2.0–3.0 | | Manganese (Mn) | ≤ 2.00 | ≤ 2.00 | | Silicon (Si) | ≤ 1.00 | ≤ 0.75 | | Phosphorus (P) | ≤ 0.045 | ≤ 0.025 | | Sulfur (S) | ≤ 0.030 | ≤ 0.010 | | Nitrogen (N) | ≤ 0.11 | ≤ 0.10 | | Iron (Fe) | Balance | Balance | **Key Alloying Elements Significance:** - **Low Carbon (≤0.03%):** Prevents chromium carbide precipitation during welding ("sensitization"), maintaining corrosion resistance in heat-affected zones - **Molybdenum (2-3%):** Enhances resistance to pitting and crevice corrosion, particularly in chloride environments - **Chromium (17-19%):** Forms passive oxide layer for general corrosion resistance - **Nickel (12-14%):** Stabilizes austenitic structure, improves ductility and fabrication properties ## Physical Properties (Annealed Condition) | Property | Value | |----------|-------| | Density | 7.98 g/cm³ | | Melting Point | 1375–1400 °C | | Thermal Conductivity | 16.3 W/m·K (at 20°C) | | Specific Heat Capacity | 500 J/kg·K (at 20°C) | | Electrical Resistivity | 0.74 μΩ·m | | Modulus of Elasticity | 193 GPa | | Magnetic Properties | Essentially non-magnetic (paramagnetic) in annealed condition | | Coefficient of Thermal Expansion | 16.0 × 10⁻⁶/K (20–100°C) | | Thermal Diffusivity | 4.0 mm²/s | ## Mechanical Properties (Annealed Condition - ASTM F138) | Property | Minimum Requirement | Typical Value | |----------|---------------------|---------------| | Tensile Strength (Rm) | ≥ 485 MPa | 530–680 MPa | | Yield Strength (Rp0.2) | ≥ 170 MPa | 220–300 MPa | | Elongation at Break (A) | ≥ 40% | 45–60% | | Reduction of Area (Z) | ≥ 50% | 65–75% | | Hardness (Brinell) | ≤ 217 HBW | 150–190 HBW | | Hardness (Rockwell) | ≤ 95 HRB | 80–90 HRB | | Fatigue Strength | 240–280 MPa (10⁷ cycles) | **Note:** For medical implants, specific cold working conditions (e.g., Grade 1, 2, 3, 4) are defined with increasing strength levels achieved through controlled cold working. ## Heat Treatment and Processing - **Solution Annealing:** 1010–1120°C followed by rapid quenching to dissolve carbides and maintain homogeneous austenitic structure - **Stress Relieving:** 400–475°C to relieve internal stresses without compromising corrosion resistance - **No Phase Transformation:** Cannot be hardened by heat treatment; strength increased through cold working only - **Passivation:** Nitric acid treatment (20–50% at 20–60°C) to enhance chromium oxide layer formation - **Special Note:** Medical-grade 316L typically undergoes stricter processing controls including vacuum melting (VIM/VAR) for implant applications ## Product Applications in Medical Field X2CrNiMo18-10 is the material of choice for applications requiring the highest corrosion resistance and biocompatibility: ### **Critical Medical Applications:** 1. **Surgical Implants:** - Bone screws, plates, and nails - Fracture fixation devices - Spinal implants (non-fusion applications) - Temporary implants 2. **Surgical Instruments:** - Microsurgical instruments - Cardiovascular surgical tools - Orthopedic instruments in contact with implants - Instruments for minimally invasive surgery 3. **Medical Device Components:** - Components for drug delivery systems - Surgical staplers and clip appliers - Endoscopic instrument shafts - Needles and cannulas 4. **Hospital Equipment:** - Surgical tables and lights - Sterilization containers - Implant storage systems ### **Advantages for Medical Use:** - **Superior Biocompatibility:** Extensive clinical history in implant applications - **Exceptional Corrosion Resistance:** Withstands harsh body fluids and sterilization - **Non-Magnetic Properties:** Essential for MRI compatibility - **Excellent Fabricability:** Can be formed into complex shapes - **Proven Long-Term Performance:** Decades of successful clinical use ## Corrosion Resistance 316L offers exceptional corrosion resistance, particularly in chloride-containing environments: ### **Resistance to Specific Media:** - **Excellent:** Body fluids (blood, serum, interstitial fluid), physiological saline, sterilization solutions - **Superior:** Chloride solutions (compared to 304/L grades) - **Good:** Organic acids, alkalis, oxidizing agents - **Moderate:** Sulfuric acid, phosphoric acid ### **Specific Corrosion Mechanisms:** - **Pitting Resistance Equivalent (PRE):** ≥25 (Cr% + 3.3×Mo% + 16×N%) - **Crevice Corrosion:** Excellent resistance due to molybdenum content - **Stress Corrosion Cracking:** Good resistance in chloride environments up to 60°C - **Intergranular Corrosion:** Minimal risk due to low carbon content - **Galvanic Corrosion:** Compatible with most implant metals (titanium, cobalt-chromium) ### **Sterilization Compatibility:** - **Autoclaving (steam):** Excellent (121–134°C, multiple cycles) - **Dry Heat:** Suitable (up to 250°C) - **Chemical Sterilization:** Compatible with ETO, glutaraldehyde, hydrogen peroxide plasma - **Radiation Sterilization:** No significant degradation from gamma or e-beam irradiation ## Fabrication and Processing for Medical Use ### **Machinability:** - Fair machinability (40% of free-cutting steel) - Work hardens rapidly – requires sharp tools, slow speeds, positive rake angles - Recommended: Carbide tools, adequate cooling/lubrication - Medical-grade material often supplied with specific machinability characteristics ### **Forming and Joining:** - **Excellent cold working properties** – can be deep drawn, stretch formed, bent - **Superior Weldability:** All standard methods (TIG preferred for medical devices) - No preheating required; post-weld annealing generally unnecessary due to low carbon - Laser welding and electron beam welding commonly used for precision medical components ### **Surface Treatments:** - **Electropolishing:** Standard for implant surfaces – improves corrosion resistance, reduces bacterial adhesion, removes surface contaminants - **Passivation:** Essential for restoring chromium oxide layer after machining - **Surface Texturing:** For specific biological responses in implants - **Coatings:** Hydroxyapatite or other bioactive coatings for orthopedic implants ## Biocompatibility and Medical Certification ### **ISO 10993 Compliance:** - Cytotoxicity: Non-cytotoxic (ISO 10993-5) - Sensitization: Generally non-sensitizing (ISO 10993-10) - Irritation: Non-irritating (ISO 10993-10) - Systemic toxicity: Non-toxic (ISO 10993-11) - Genotoxicity: Non-genotoxic (ISO 10993-3) ### **Special Considerations:** - **Nickel Release:** Low but measurable; considerations for nickel-sensitive patients - **Implant-Grade Requirements:** Additional purification (VIM/VAR melting) for reducing inclusions - **Surface Finish:** Critical for implants – typically Ra < 0.2 μm for bone contact devices - **Cleaning Validation:** Essential for reusable instruments – withstands aggressive cleaning agents ## Quality Assurance for Medical Applications ### **Material Certification:** - EN 10204 3.1 Certificate with full traceability - Chemical analysis per heat/lot - Mechanical property certification - Microcleanliness reports (inclusion ratings per ASTM E45) - Grain size certification (ASTM E112) ### **Medical-Specific Testing:** - Corrosion testing per ASTM F2129 (Crevice and Pitting) - Inclusion rating per ASTM/ISO standards - Delta ferrite content verification (typically <0.5%) - Sterilization validation - Biocompatibility testing per ISO 10993 series ### **Industry Standards Compliance:** - FDA 21 CFR Part 820 (Quality System Regulation) - ISO 13485 (Medical Device Quality Management) - EU MDR 2017/745 (Medical Device Regulation) - JPAL (Japanese Pharmaceutical Affairs Law) ## Comparison with Other Medical Stainless Steels | Property | X2CrNiMo18-10 (316L) | X5CrNi18-10 (304L) | X2CrNiMoN17-13-5 (ISO 5832-9) | |----------|----------------------|---------------------|-------------------------------| | **Corrosion Resistance** | Excellent | Very Good | Superior | | **Chloride Resistance** | Excellent | Moderate | Excellent | | **PRE Number** | ≥25 | ~18 | ≥35 | | **Implant Applications** | Standard | Limited | Premium | | **MRI Compatibility** | Excellent | Excellent | Excellent | | **Fatigue Strength** | Good | Good | Excellent | | **Cost Factor** | 1.3–1.5×304L | 1.0 (Baseline) | 2.0–3.0×316L | ## Limitations and Special Considerations 1. **Not for Load-Bearing Permanent Implants:** Lower fatigue strength than cobalt-chrome or titanium alloys 2. **Nickel Sensitivity:** May require alternative materials for nickel-allergic patients 3. **Mechanical Properties:** Lower yield strength than cold-worked 316LVM grades 4. **Cost:** Higher material cost than 304/304L grades 5. **Special Processing:** Implant grade requires vacuum melting for optimal properties ## Future Developments and Alternatives - **High-Nitrogen Grades:** 316LN for improved strength and corrosion resistance - **Nickel-Free Austenitics:** Nitrogen-strengthened steels for patients with nickel allergies - **Surface-Modified 316L:** Nanostructured surfaces for enhanced biocompatibility - **Additive Manufacturing:** Special 316L powders for medical 3D printing applications ## Conclusion X2CrNiMo18-10 (AISI 316L) represents the gold standard for corrosion-resistant austenitic stainless steel in medical applications. Its unique combination of exceptionally low carbon content and molybdenum addition provides unparalleled resistance to corrosion in chloride-containing environments, making it ideal for surgical instruments, medical devices, and temporary implants that require repeated sterilization and exposure to aggressive body fluids. While its mechanical properties may limit its use in permanent load-bearing implants, its excellent biocompatibility, proven clinical history, and superior fabrication characteristics ensure its continued dominance in critical medical applications. Proper material selection, processing, and surface treatment allow 316L to meet the stringent requirements of modern medical device regulations while providing reliable performance throughout the product lifecycle. As medical technology advances, 316L continues to evolve through improved melting practices, surface modifications, and innovative manufacturing techniques, maintaining its position as an indispensable material in healthcare technology. -:- For detailed product information, please contact sales. -: X2CrNi1810 Austenitic Stainless Steel for medical instruments Specification Dimensions Size： Diameter 20-1000 mm Length <7409 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. -: X2CrNi1810 Austenitic Stainless Steel for medical instruments Properties -:- For detailed product information, please contact sales. -:

Applications of X2CrNi1810 Austenitic Stainless Steel Sheet,Plate for medical instruments -:- For detailed product information, please contact sales. -: Chemical Identifiers X2CrNi1810 Austenitic Stainless Steel Sheet,Plate for medical instruments -:- For detailed product information, please contact sales. -:

Packing of X2CrNi1810 Austenitic Stainless Steel Sheet/Plate for medical instruments -:- 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 Sheet/Plate 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 3880 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