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304 Stainless Steel Medical Device Spare Parts CNC Milling
Product Description
304 Stainless Steel Medical Device Component CNC Milling is a precision manufacturing service specializing in the production of functional parts and accessories for medical equipment using medical-grade 304 stainless steel. This process utilizes advanced Computer Numerical Control (CNC) milling technology to create complex, high-tolerance components that meet the stringent requirements of the healthcare industry. 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.
Product Processing
Design & Engineering Analysis: Review of customer CAD models with Design for Manufacturability (DFM) and medical device regulatory considerations.
Material Certification & Preparation: Sourcing of certified 304 stainless steel plate, bar, or block (ASTM A240) with full traceability. Precision cutting to size.
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 required by medical designs.
Secondary Operations: Precision drilling, tapping, reaming, and boring to create holes, threads, and precise interfaces for assembly.
Deburring & Edge Radiusing: Comprehensive removal of all sharp edges and burrs—a critical safety step for medical components.
Surface Finishing (Post-Machining):
Vibratory/Tumbling Finishing: For initial smoothing.
Electropolishing: A common medical finish for a smooth, clean, corrosion-resistant, and easy-to-clean surface.
Passivation: Chemical treatment to restore/enhance the protective chromium oxide layer.
Bead Blasting: For a uniform matte aesthetic.
Intensive Cleaning: Multi-stage ultrasonic cleaning in validated processes to meet medical cleanliness standards (e.g., low particulate count, non-volatile residue).
Quality Inspection & Documentation: 100% dimensional inspection (CMM, optical comparators), visual inspection, and provision of material certificates and inspection reports. Biocompatibility testing support available.
Cleanroom Packaging: Packaging in controlled environments to prevent contamination.
Product Applications
Surgical Instrument Components: Housings, handles, triggers, guards, and internal mechanisms for handheld and powered surgical tools.
Diagnostic & Monitoring Equipment: Housings, frames, brackets, sensor mounts, and covers for imaging systems (e.g., ultrasound probes), patient monitors, and analyzers.
Medical Device Housings & Enclosures: Protective cases and structural shells for infusion pumps, ventilators, dialysis machines, and laboratory instruments.
Dental Equipment Parts: Components for chairs, handpiece holders, light arms, and instrument trays.
Hospital & Lab Furniture Components: Adjustable arms, rails, connectors, and supports for beds, lights, and workstations.
Sterilization & Processing Trays: Custom trays for organizing and sterilizing surgical instruments.
Technical Parameters
Parameter Category
Specification
Details & Options
Material
Alloy
304 Stainless Steel (ASTM A240, UNS S30400). The most common stainless steel for general medical applications due to its excellent corrosion resistance, formability, and cost-effectiveness.
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 (Machining Envelope)
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 like bearing seats or sealing surfaces)
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.
304 Stainless Steel is suitable for limited or prolonged skin contact and is widely used in medical devices. It supports biological safety evaluation.
Cleanliness Standards
Can be cleaned and packaged to meet specific particle count and bioburden levels required for medical devices. Processes compatible with ISO 14644 cleanroom standards.
Sterilization Compatibility
Method Compatibility
Components are fully compatible with all standard medical sterilization methods: Autoclave (Steam), Ethylene Oxide (EtO), Gamma Radiation, Hydrogen Peroxide Plasma.
Quality & Compliance
Quality Management System
ISO 13485:2016 certified manufacturing is essential for medical device components.
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.
Expert analysis to optimize part design for cost, manufacturability, and performance.
Assembly & Kitting
Sub-assembly and full device assembly services available.
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer,Exporter,Seller
Year Established:
2018
Total Annual:
1 million-2 million
Employee Number:
20~50
Ecer Certification：
Verified Supplier
Dongguan Yue Lin Sen Metal Technology Co., Ltd. has passed the GB/T 19001-2016/ISO 9001:2015 quality management system certification and the GB/T 42061-2022/ISO 13485:2016 medical device quality management system certification. It specializes in the research and production of non-standard metal medi... Dongguan Yue Lin Sen Metal Technology Co., Ltd. has passed the GB/T 19001-2016/ISO 9001:2015 quality management system certification and the GB/T 42061-2022/ISO 13485:2016 medical device quality management system certification. It specializes in the research and production of non-standard metal medi...
