Brief: Curious about how this performs in practice? Join us for a hands-on look at the precision manufacturing of 304 stainless steel medical device spare parts through advanced CNC milling. This video demonstrates the entire process from material preparation to final inspection, showcasing how complex, high-tolerance components are created for surgical instruments, diagnostic equipment, and other critical healthcare applications.
Related Product Features:
Manufactured from medical-grade 304 stainless steel (ASTM A240) offering excellent corrosion resistance and biocompatibility.
Utilizes multi-axis CNC milling centers (3-axis, 4-axis, and 5-axis) for creating complex geometries and intricate medical device features.
Achieves precision tolerances as tight as ±0.0125 mm for critical features like bearing seats and sealing surfaces.
Includes comprehensive post-processing with medical-grade finishes such as electropolishing and passivation for enhanced cleanability.
Undergoes intensive ultrasonic cleaning and cleanroom packaging to meet stringent medical cleanliness standards.
Fully compatible with all standard medical sterilization methods including autoclave, EtO, gamma radiation, and hydrogen peroxide plasma.
Produced under ISO 13485:2016 certified quality management system with full material and process traceability.
Supports both prototyping and scalable production for R&D, clinical trials, and commercial medical device manufacturing.
FAQs:
What are the key advantages of using 304 stainless steel for medical device components?
304 stainless steel offers excellent corrosion resistance, high strength, good machinability, and is hygienic and non-magnetic in its annealed state. It provides good biocompatibility for limited or prolonged skin contact, making it suitable for both direct and indirect patient contact applications in medical devices.
What level of precision can be achieved with your CNC milling process?
Our CNC milling process can achieve standard tolerances of ±0.05 mm, precision tolerances of ±0.025 mm, and high-precision tolerances of ±0.0125 mm for critical features. We maintain positioning accuracy up to ±0.005 mm and repeatability up to ±0.0025 mm using advanced multi-axis machining centers.
How do you ensure medical-grade cleanliness and sterilization compatibility?
We perform intensive multi-stage ultrasonic cleaning in validated processes to meet medical cleanliness standards for low particulate count and non-volatile residue. Components are packaged in controlled cleanroom environments and are fully compatible with all standard medical sterilization methods including autoclave, ethylene oxide, gamma radiation, and hydrogen peroxide plasma.
What quality certifications and documentation do you provide?
We operate under ISO 13485:2016 certified quality management system specifically for medical devices. We provide 100% dimensional inspection using CMM and optical comparators, visual inspection reports, material certificates, and full traceability documentation for all materials and processes.