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304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling

304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling

Brand Name: Yue lin sen
Model Number: Y2662
MOQ: 100pcs
Price: 0.5-20
Payment Terms: T/T
Supply Ability: 5000000pcs
Detail Information
Place of Origin:
Guangdong
Certification:
ISO9001 ISO13485
Payment Term:
TT Westerm Union MomeyGram Paypal
Biocompatibility:
Meets Biocompatibility Standards
Process:
Cnc Machining+deburrs
Standard:
Non-standard Parts
Application:
Medical Devices, Surgical Instruments
Inspection:
100% Dimensional Inspection, CMM Reports
Cnc Milling Tolerance:
± 0.05 Mm (± 0.002")
Wall Thickness:
0.1 Mm - 3.0 Mm
Finish:
Anodizing
Surfacefinish:
Ra 0.8 - 1.6 µm
Heattreatment:
Available Upon Request
Size:
Customers' Requirement
Manufacturingprocess:
CNC Machining, Milling, Turning
Sizerange:
Custom Sizes Available, Typically 1mm To 300mm
Leadtime:
2 To 6 Weeks
Packaging Details:
Vacuum packaging cardboard box
Highlight:

304 Stainless Steel Medical Device Spare Parts

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Biocompatibility Standards CNC Milling Parts

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High Precision CNC Milling Medical Machining Parts

Product Description
304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling 0 304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling 1
Our 304 Stainless Steel Medical Device Component CNC Milling service specializes in producing precision functional parts and accessories for medical equipment. Utilizing advanced Computer Numerical Control (CNC) milling technology, we create complex, high-tolerance components that meet stringent healthcare industry requirements. The resulting parts offer excellent corrosion resistance, durability, cleanability, and biocompatibility, making them suitable for both direct and indirect patient contact applications in diagnostic, therapeutic, and surgical devices.
Manufacturing Process
1. Design & Engineering Analysis: Review of customer CAD models with Design for Manufacturability (DFM) and medical device regulatory considerations.
2. Material Certification & Preparation: Sourcing of certified 304 stainless steel plate, bar, or block (ASTM A240) with full traceability. Precision cutting to size.
3. Multi-Axis CNC Milling: Machining on 3-axis, 4-axis, or 5-axis CNC milling centers to achieve complex geometries, thin walls, and intricate features.
4. Secondary Operations: Precision drilling, tapping, reaming, and boring to create holes, threads, and precise interfaces for assembly.
5. Deburring & Edge Radiusing: Comprehensive removal of all sharp edges and burrs—a critical safety step for medical components.
6. Surface Finishing:
  • Vibratory/Tumbling Finishing for initial smoothing
  • Electropolishing for smooth, clean, corrosion-resistant surfaces
  • Passivation to restore/enhance protective chromium oxide layer
  • Bead Blasting for uniform matte aesthetic
7. Intensive Cleaning: Multi-stage ultrasonic cleaning in validated processes to meet medical cleanliness standards.
8. Quality Inspection & Documentation: 100% dimensional inspection, visual inspection, and provision of material certificates and inspection reports.
9. Cleanroom Packaging: Packaging in controlled environments to prevent contamination.
Applications
  • Surgical Instrument Components: Housings, handles, triggers, guards, and internal mechanisms
  • Diagnostic & Monitoring Equipment: Housings, frames, brackets, sensor mounts, and covers
  • Medical Device Housings & Enclosures: Protective cases and structural shells
  • Dental Equipment Parts: Components for chairs, handpiece holders, and instrument trays
  • Hospital & Lab Furniture Components: Adjustable arms, rails, connectors, and supports
  • Sterilization & Processing Trays: Custom trays for organizing and sterilizing surgical instruments
Technical Specifications
Parameter Category Specification Details & Options
Material Alloy 304 Stainless Steel (ASTM A240, UNS S30400). The most common stainless steel for general medical applications.
Key Properties Good corrosion resistance, high strength, good machinability, hygienic, non-magnetic in annealed state.
Machining Capabilities CNC Equipment 3-axis, 4-axis, and 5-axis simultaneous machining centers.
Positioning Accuracy Up to ±0.005 mm
Repeatability Up to ±0.0025 mm
Geometric Capabilities Minimum Feature Size 0.5 mm
Minimum Wall Thickness 0.75 mm (stable), 0.5 mm (possible with careful design)
Maximum Part Size Up to 600 mm x 500 mm x 300 mm (machine dependent)
Tolerances Standard Machining Tolerance ± 0.05 mm (ISO 2768-m)
Precision Machining Tolerance ± 0.025 mm
High-Precision Tolerance ± 0.0125 mm (for critical features)
Surface Finish (Ra) As-Machined 1.6 μm - 3.2 μm
Fine Machined 0.8 μm - 1.6 μm
Electropolished 0.4 μm, 0.2 μm, <0.1 μm (Mirror) - Common medical finish
Post-Processing Standard Finishes Passivation (ASTM A967), Electropolishing, Bead Blasting
Biocompatibility & Cleanliness Biocompatibility (ISO 10993) Suitable for limited or prolonged skin contact, supports biological safety evaluation
Cleanliness Standards Can be cleaned and packaged to meet specific particle count and bioburden levels
Sterilization Compatibility Method Compatibility Autoclave (Steam), Ethylene Oxide (EtO), Gamma Radiation, Hydrogen Peroxide Plasma
Quality & Compliance Quality Management System ISO 13485:2016 certified manufacturing
Inspection & Metrology First Article Inspection (FAI), CMM reporting, material certification
Traceability Full material and process lot traceability
Production Scope Prototyping & Low-Volume Ideal for R&D, clinical trials, and pilot production
Medium to High-Volume Production Scalable production suitable for commercial device manufacturing
Lead Times Prototypes: 2-5 weeks; Production: 6-12 weeks
Design & Value-Added Services Design for Manufacturing (DFM) Expert analysis to optimize part design for cost, manufacturability, and performance
Assembly & Kitting Sub-assembly and full device assembly services available
304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling 2 304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling 3