X2CrNi1911 Austenitic stainless Steel Wire,for medical instruments

X2CrNi1911 Austenitic stainless Steel Wire for medical instruments Product Information -:- For detailed product information, please contact sales. -: X2CrNi1911 Austenitic stainless Steel Wire for medical instruments Synonyms -:- For detailed product information, please contact sales. -:

X2CrNi1911 Austenitic stainless steel for medical instruments Product Information -:- For detailed product information, please contact sales. -: # X2CrNi19-11 (EN 1.4307) Austenitic Stainless Steel for Medical Instruments ## Overview X2CrNi19-11 is a low-carbon, chromium-nickel austenitic stainless steel designed to provide excellent corrosion resistance and formability while minimizing the risk of intergranular corrosion. As a member of the 304L family, this alloy offers an optimized balance of mechanical properties, fabricability, and biocompatibility, making it suitable for a wide range of medical instruments and equipment where reliable performance and ease of sterilization are essential. ## International Standards & Designations | Standard System | Designation | |----------------|-------------| | **European (EN)** | 1.4307 | | **ISO** | X2CrNi19-11 | | **UNS** | S30403 | | **AISI/ASTM** | 304L | | **Japanese (JIS)** | SUS304L | | **Chinese (GB)** | 00Cr19Ni10 | | **Medical Standards** | ISO 7153-1 (Surgical Instruments) | ## Chemical Composition (Typical, % by weight) | Element | Minimum (%) | Maximum (%) | Optimal Range (%) | Function | |---------|-------------|-------------|-------------------|----------| | **Carbon (C)** | - | 0.030 | 0.015-0.025 | Reduced carbide precipitation | | **Chromium (Cr)** | 18.00 | 20.00 | 18.50-19.50 | Corrosion resistance | | **Nickel (Ni)** | 10.00 | 12.00 | 10.50-11.50 | Austenite stabilization | | **Manganese (Mn)** | - | 2.00 | 1.00-1.80 | Austenite stabilization, deoxidizer | | **Silicon (Si)** | - | 1.00 | 0.30-0.60 | Deoxidizer | | **Phosphorus (P)** | - | 0.045 | ≤0.035 | Impurity control | | **Sulfur (S)** | - | 0.030 | ≤0.015 | Impurity control | | **Nitrogen (N)** | - | 0.11 | 0.05-0.09 | Optional strengthening | | **Iron (Fe)** | Balance | Balance | Balance | Base element | **Key Composition Features:** - **Ultra-low carbon content** (<0.03%) prevents sensitization during welding and heat treatment - **Balanced Cr/Ni ratio** ensures stable austenitic structure - **Controlled nitrogen** option for enhanced strength without compromising corrosion resistance ## Physical Properties (Annealed Condition) | Property | Value | Test Condition | |----------|-------|----------------| | **Density** | 7.90 g/cm³ | 20°C | | **Melting Point** | 1400-1450°C | - | | **Thermal Conductivity** | 16.2 W/m·K | 20°C | | **Specific Heat Capacity** | 500 J/kg·K | 20°C | | **Electrical Resistivity** | 0.72 μΩ·m | 20°C | | **Modulus of Elasticity** | 193 GPa | 20°C | | **Magnetic Permeability** | ≤1.02 | Annealed | | **Coefficient of Thermal Expansion** | 17.2 × 10⁻⁶/K | 20-100°C | | **Thermal Diffusivity** | 4.2 mm²/s | 20°C | ## Mechanical Properties ### **Annealed Condition (Typical Values):** | Property | Value | Standard | |----------|-------|----------| | **Tensile Strength (Rm)** | 500-700 MPa | EN 10088-3 | | **Yield Strength (Rp0.2)** | ≥200 MPa | EN 10088-3 | | **Elongation at Break (A₅)** | ≥45% | EN 10088-3 | | **Reduction of Area (Z)** | ≥70% | - | | **Hardness (Brinell)** | ≤215 HBW | EN 10088-3 | | **Hardness (Rockwell B)** | ≤95 HRB | - | | **Impact Toughness** | >150 J (Charpy V) | 20°C | | **Fatigue Strength** | 240-280 MPa | 10⁷ cycles | ### **Cold Worked Properties (Examples):** | Cold Work Level | Tensile Strength | Yield Strength | Hardness | Elongation | |-----------------|------------------|----------------|----------|------------| | **¼ Hard** | 700-850 MPa | 350-450 MPa | 75-90 HRB | 35-45% | | **½ Hard** | 850-1000 MPa | 600-750 MPa | 90-100 HRB | 20-30% | | **Full Hard** | 1000-1200 MPa | 850-1000 MPa | ≤110 HRB | 10-15% | ## Heat Treatment ### **Solution Annealing:** - **Temperature:** 1010-1120°C - **Soak Time:** 15-30 minutes per 25 mm thickness - **Cooling:** Rapid water quenching or air cooling - **Purpose:** Dissolve carbides, homogenize structure, restore corrosion resistance ### **Stress Relieving:** - **Temperature:** 400-450°C - **Time:** 1-2 hours - **Purpose:** Relieve internal stresses without significant property changes ### **Special Considerations:** - No phase transformation hardening possible - Avoid prolonged exposure to 450-850°C range to prevent sensitization - Post-weld heat treatment generally not required ## Corrosion Resistance ### **General Performance:** - **Excellent** resistance to atmospheric corrosion, fresh water, steam - **Good** resistance to most organic acids, alkalis, oxidizing agents - **Moderate** resistance to chloride environments (not for marine applications) - **Poor** resistance to reducing acids, hydrochloric acid ### **Medical Environment Specific:** | Environment | Resistance Level | Notes | |-------------|-----------------|-------| | **Physiological Saline** | Excellent | No significant corrosion at body temperature | | **Blood & Body Fluids** | Excellent | Compatible with all biological fluids | | **Disinfectants** | Good to Excellent | Alcohol-based: Excellent; Chlorine-based: Good | | **Sterilization Methods** | Excellent | Compatible with all standard medical sterilization | ### **Intergranular Corrosion Resistance:** - **Excellent** due to low carbon content - **Stable** in heat-affected zones of welds - **Test Method:** Passes ASTM A262 Practice E (Strauss Test) ## Product Applications in Medical Field ### **Surgical Instruments:** 1. **Non-Cutting Instruments:** - Forceps, clamps, and hemostats - Retractors and specula - Needle holders and towel clips - Surgical hooks and probes 2. **Instrument Components:** - Handles and grips - Adjustment mechanisms - Spring components - Fasteners and connectors ### **Medical Equipment:** 1. **Sterilization Equipment:** - Autoclave trays and racks - Sterilization containers - Washer-disinfector components 2. **Patient Care Equipment:** - IV poles and stands - Bed frames and rails - Medical carts and trolleys 3. **Diagnostic Equipment:** - X-ray and imaging components - Laboratory equipment parts - Monitor arms and supports ### **Dental Applications:** - Dental instrument handles - Bracket and archwire components (orthodontics) - Laboratory equipment - Sterilization tray systems ### **Advantages for Medical Use:** - **Ease of Cleaning:** Smooth, non-porous surface - **Sterilization Compatibility:** Withstands repeated sterilization cycles - **Biocompatibility:** Suitable for tissue contact - **Cost-Effectiveness:** Balance of performance and cost - **Manufacturing Flexibility:** Easy to form, weld, and machine ## Fabrication Characteristics ### **Machinability:** - **Rating:** Fair (approximately 45% of free-cutting steel) - **Recommended Practices:** - Use sharp tools with positive rake angles - Moderate speeds with adequate feeds - Copious coolant flow - Consider work-hardening effects - **Tool Materials:** Carbide or high-speed steel with appropriate coatings ### **Forming Operations:** - **Cold Forming:** Excellent - suitable for deep drawing, bending, spinning - **Hot Working:** 1150-900°C range - **Springback:** Significant due to high work hardening rate - **Annealing:** May be required between severe forming operations ### **Welding Characteristics:** | Welding Method | Suitability | Filler Metal | Notes | |----------------|-------------|--------------|-------| | **TIG (GTAW)** | Excellent | ER308L, ER308LSi | Primary choice for medical | | **MIG (GMAW)** | Excellent | ER308L, ER308LSi | For production welding | | **Resistance** | Good | - | Spot and seam welding | | **Plasma** | Excellent | ER308L | Precision applications | | **Laser/EB** | Excellent | ER308L | Minimal heat input | ### **Surface Finishing:** - **Mechanical Polishing:** Can achieve mirror finish (Ra < 0.1 μm) - **Electropolishing:** Enhances corrosion resistance and cleanability - **Passivation:** Nitric acid treatment per ASTM A967 - **Special Coatings:** Various medical-grade surface treatments available ## Biocompatibility and Regulatory Compliance ### **ISO 10993 Evaluation:** - **Cytotoxicity:** Typically non-cytotoxic (ISO 10993-5) - **Sensitization:** Low risk (ISO 10993-10) - **Irritation:** Non-irritating (ISO 10993-10) - **Systemic Toxicity:** Non-toxic (ISO 10993-11) ### **Regulatory Status:** - **FDA:** Generally recognized as safe for medical devices - **EU MDR:** Compliant with appropriate technical documentation - **Japan PMDA:** Acceptable with proper certification - **China NMPA:** Registered for medical applications ### **Special Considerations:** - **Nickel Sensitivity:** May require alternative materials for nickel-allergic patients - **Surface Finish:** Critical for cleanability and biocompatibility - **Sterilization Validation:** Required for medical device applications ## Quality Assurance for Medical Manufacturing ### **Material Certification:** - **EN 10204 3.1 Certificate:** Mandatory for medical applications - **Chemical Analysis:** Per heat/lot - **Mechanical Testing:** Tensile, hardness, bend tests - **Corrosion Testing:** As specified by application ### **Medical-Specific Requirements:** | Requirement | Standard/Test | Acceptance Criteria | |-------------|--------------|---------------------| | **Surface Finish** | ISO 4287 | Ra ≤ 0.8 μm (typical for instruments) | | **Cleanliness** | ISO 19227 | No visible contamination | | **Passivation** | ASTM A967 | No iron contamination | | **Sterilization** | ISO 17665 | Validated for intended method | ### **Traceability Requirements:** - Full traceability from raw material to finished device - Heat/lot identification throughout manufacturing - Documentation of all processing steps - Final device identification and labeling ## Comparison with Similar Medical Grades | Property | X2CrNi19-11 (1.4307) | X5CrNi18-10 (1.4301) | X2CrNiMo17-12-2 (1.4404) | |----------|----------------------|----------------------|--------------------------| | **Carbon Content** | ≤0.030% | ≤0.07% | ≤0.030% | | **Corrosion Resistance** | Very Good | Very Good | Excellent | | **Intergranular Corrosion** | Excellent | Good | Excellent | | **Weldability** | Excellent | Very Good | Excellent | | **Medical Applications** | General instruments | General instruments | Corrosive environments | | **Cost Factor** | 1.0 | 0.9 | 1.3 | ## Limitations and Design Considerations ### **Material Limitations:** 1. **Not for Cutting Edges:** Insufficient hardness for scalpels or cutting tools 2. **Chloride Sensitivity:** Limited use in high-chloride environments 3. **Strength Limitations:** Lower yield strength than martensitic grades 4. **Work Hardening:** Requires consideration in forming operations ### **Design Guidelines:** 1. **Wall Thickness:** Minimum 0.5 mm for structural components 2. **Radii:** Minimum bend radius of 1× thickness 3. **Surface Finish:** Specify appropriate Ra values for function 4. **Tolerances:** Account for springback in formed components ### **Sterilization Considerations:** - **Autoclave Cycles:** >1000 cycles without significant degradation - **Chemical Compatibility:** Verify with specific sterilants - **Temperature Limits:** Maximum 250°C for extended periods ## Economic and Production Aspects ### **Cost Factors:** - **Material Cost:** Moderate (standard austenitic grade) - **Processing Cost:** Low to moderate (good fabricability) - **Tooling Cost:** Standard for stainless steel - **Life Cycle Cost:** Favorable due to durability ### **Production Recommendations:** - **Batch Size:** Suitable for both small and large production runs - **Lead Time:** Generally readily available - **Inventory:** Standard stock sizes available - **Secondary Operations:** Minimal required for most applications ## Future Developments and Trends ### **Material Innovations:** - **High-Nitrogen Variants:** For increased strength - **Improved Surface Treatments:** Enhanced antibacterial properties - **Additive Manufacturing:** Specialized powder formulations ### **Medical Applications:** - **Single-Use Instruments:** Cost optimization for disposable devices - **Minimally Invasive Tools:** Miniaturization opportunities - **Smart Instruments:** Integration with electronic components ## Conclusion X2CrNi19-11 (304L) represents a versatile and reliable austenitic stainless steel for medical instrument applications, offering an optimal balance of corrosion resistance, manufacturability, and cost-effectiveness. Its low carbon content ensures excellent resistance to intergranular corrosion, making it particularly suitable for welded components and instruments subjected to repeated sterilization cycles. While not possessing the specialized properties of martensitic grades for cutting applications or the enhanced corrosion resistance of molybdenum-bearing grades for extreme environments, X2CrNi19-11 provides more than adequate performance for the majority of medical instruments and equipment. Its proven track record in healthcare applications, combined with excellent fabricability and consistent quality, ensures its continued relevance in medical device manufacturing. For medical device designers and manufacturers, X2CrNi19-11 offers a "workhorse" material solution that meets the essential requirements of hygiene, durability, and biocompatibility while supporting efficient manufacturing processes and cost control. Proper selection, processing, and surface finishing enable this alloy to deliver reliable performance throughout the product lifecycle, meeting the stringent demands of modern healthcare delivery. -:- For detailed product information, please contact sales. -: X2CrNi1911 Austenitic stainless steel for medical instruments Specification Dimensions Size： Diameter 20-1000 mm Length <7419 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. -: X2CrNi1911 Austenitic stainless steel for medical instruments Properties -:- For detailed product information, please contact sales. -:

Applications of X2CrNi1911 Austenitic stainless Steel Wire for medical instruments -:- For detailed product information, please contact sales. -: Chemical Identifiers X2CrNi1911 Austenitic stainless Steel Wire for medical instruments -:- For detailed product information, please contact sales. -:

Packing of X2CrNi1911 Austenitic stainless Steel Wire 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 Wire 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 3890 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