X2CrNi1911 Austenitic stainless Steel Flange,for medical instruments

1,We Manufacturing processes are primarily classified into four types: 1:Forging, 2:Casting, 3:Cutting, 4:Rolling. 2,We can manufacture in accordance with these standards. Standards: GB Series (Chinese Standards), JB Series (Machinery Standards), HG Series (Chemical Industry Standards), ASME B16.5 (American Standards), BS4504 (British Standards), DIN (German Standards), and JIS (Japanese Standards). Internationally, there are two primary systems of pipe flange standards: the European system, represented by the German DIN standards (including those of the former Soviet Union), and the American system, represented by the US ANSI pipe flange standards. Other common standards include: the Chinese Ministry of Machinery Industry standards (JB series), the Ministry of Chemical Industry standards (HG series), the Chinese National Standard *GB/T 9112–9124-2010 Steel Pipe Flanges*, as well as US standards (ASME B16.5), British standards (BS4504), German standards (DIN), Japanese standards (JIS), and marine standards (CBM), among others. The nominal pressure ratings for the PN series are designated by "PN" and comprise the following nine levels: PN2.5, PN6, PN10, PN16, PN25, PN40, PN63, PN100, and PN160. The nominal pressure ratings for the Class series are designated by "Class" and comprise the following six levels: Class150, Class300, Class600, Class900, Class1500, and Class2500. Flange Classification 1. **According to Chemical Industry Standards:** Flanges are classified as follows: Plate Flat Welding Flange (PL), Necked Flat Welding Flange (SO), Necked Butt Welding Flange (WN), Integral Flange (IF), Socket Welding Flange (SW), Threaded Flange (Th), Butt Welding Ring Loose Flange (PJ/SE), Blind Flange (BL), Flat Welding Ring Loose Flange (PJ/PJ), and Lined Blind Flange (BL(s)). 2. **According to Petrochemical (SH) Industry Standards:** Flanges are classified as follows: Threaded Flange (PL), Butt Welding Flange (WN), Flat Welding Flange (SO), Socket Welding Flange (SW), Loose Flange (LJ), and Blind Flange (no specific designation). 3. **According to Machinery (JB) Industry Standards:** Flanges are classified as follows: Integral Flange, Butt Welding Flange, Plate Flat Welding Flange, Butt Welding Ring Plate Loose Flange, Flat Welding Ring Plate Loose Flange, Lap Joint Ring Plate Loose Flange, and Blind Flange. 4. **According to Connection Method/Type:** Flanges are classified as follows: Plate Flat Welding Flange, Necked Flat Welding Flange, Necked Butt Welding Flange, Socket Welding Flange, Threaded Flange, Blind Flange, Necked Butt Welding Ring Loose Flange, Flat Welding Ring Loose Flange, Ring-Type Joint (RTJ) Flange and Blind Flange, Large-Diameter Plate Flange, Large-Diameter High-Neck Flange, Figure-8 Blind Plate, Butt Welding Ring Loose Flange, etc. 5. **According to the Component Being Connected:** Flanges can be classified into Vessel Flanges and Pipe Flanges. 6. **According to Structural Type:** Flanges include Integral Flanges, Threaded Flanges, Flat Welding Flanges, Butt Welding Flanges, Lap Joint (Loose/Swivel) Flanges, and Blind Flanges. A flange—also referred to as a flange plate or rim—is a component used to connect shafts to one another, or, more commonly, to join the ends of pipes. Flanges are also utilized at the inlet and outlet ports of equipment to facilitate connections between two devices—for instance, the flange on a speed reducer. A "flange connection" or "flanged joint" refers to a detachable joint assembly comprising three interconnected elements—a flange, a gasket, and bolts—that together form a sealed structural unit. In the context of piping systems, a "pipe flange" specifically denotes a flange used for plumbing within the installation; when applied to equipment, it refers to the inlet or outlet flange of that specific device. Flanges feature a series of holes through which bolts are inserted to securely fasten the two flanges together, while a gasket placed between the flanges ensures a leak-proof seal. Flanges are broadly categorized into three types: threaded (screw-in) flanges, welded flanges, and clamp-type flanges. Flanges are invariably used in pairs; threaded flanges are suitable for low-pressure piping applications, whereas welded flanges are required for systems operating at pressures exceeding 4 kilograms per square centimeter. A sealing gasket is inserted between the two flange plates, which are then firmly secured using bolts. The thickness of a flange—as well as the specifications of the bolts used to fasten it—vary depending on the specific pressure rating required for the application. When connecting equipment such as water pumps or valves to piping systems, the corresponding connection points on these devices are often manufactured in the shape of a matching flange; this method of attachment is also referred to as a "flange connection." Generally, any connecting component that utilizes bolts to join and seal the perimeters of two flat surfaces—such as the joints in ventilation ducts—is termed a "flange"; such components may collectively be classified as "flange-type parts." However, since such a connection often constitutes merely a *portion* of a larger device—for instance, the interface between a flange and a water pump—it would be inappropriate to classify the entire water pump itself as a "flange-type part." Conversely, smaller components—such as valves—that feature such flanged interfaces may indeed be appropriately categorized as "flange-type parts." -:- For detailed product information, please contact sales. -: X2CrNi1911 Austenitic stainless Steel Flange for medical instruments Product Information -:- For detailed product information, please contact sales. -: X2CrNi1911 Austenitic stainless Steel Flange 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 Flange for medical instruments -:- For detailed product information, please contact sales. -: Chemical Identifiers X2CrNi1911 Austenitic stainless Steel Flange for medical instruments -:- For detailed product information, please contact sales. -:

Packing of X2CrNi1911 Austenitic stainless Steel Flange 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 Flange 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