304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling
Price:
0.5-20
MOQ:
100pcs
Delivery Time:
5-8 working days
Brand:
Yue lin sen
Product Description
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 |
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Dongguan Yuelinsen Metal Technology Co., Ltd.
Location
Room 203, Building 2, Ande Alley, Changan Town, Dongguan City, Guangdong Province
Contact Person
张年红