Material
316L, 17-4 PH, 420 SS
Process
CNC Machining
Tolerance
±0.01mm
Lead Time
5-10 days
MOQ
1 piece
Biocompatibility
ISO 10993 compliant
Medical Grade Stainless Steel Parts are precision-engineered components manufactured from biocompatible stainless steel alloys that meet stringent medical industry standards. Our medical-grade stainless steel parts are primarily produced from 316L (low-carbon 316), 17-4 PH precipitation-hardening stainless, and 420 martensitic stainless steel, offering excellent corrosion resistance, superior strength, and proven biocompatibility for surgical instruments, implantable devices, and diagnostic equipment.
Our ISO 9001 certified quality management system ensures that every medical-grade stainless steel component meets the highest standards of cleanliness, traceability, and dimensional accuracy. We operate in a controlled manufacturing environment with strict contamination control protocols, material certification tracking, and comprehensive validation processes. Our advanced CNC machining centers produce medical parts with exceptional surface finishes (Ra 0.2μm or better) critical for minimization of bacterial adhesion and ease of sterilization.
Material certification is fundamental to medical device manufacturing. We provide complete material traceability including mill test reports (MTR), chemical composition analysis, and mechanical property testing. Our medical-grade stainless steel components undergo rigorous biocompatibility testing in accordance with ISO 10993 standards, ensuring cytotoxicity, sensitization, and irritation requirements are met. Whether for single-use disposable devices or long-term implantable components, our expertise in medical-grade materials and precision machining delivers reliable, regulatory-compliant parts.
| Material | 316L, 17-4 PH, 420 Stainless Steel (ASTM F899 compliant) |
| Process | CNC Milling, CNC Turning, 5-Axis Machining, Swiss Turning |
| Tolerance | ±0.01mm (±0.0004") standard, ±0.005mm available |
| Surface Finish | Ra 0.2μm or better, Polished, Electropolished, Passivated |
| Biocompatibility | ISO 10993 compliant, USP Class VI certified |
| Size Range | 0.5mm to 300mm (0.02" to 11.8") |
| Lead Time | 5-10 days for prototypes, 10-20 days for production |
| MOQ | 1 piece (no minimum order quantity) |
| Sterilization | Autoclave, Ethylene Oxide, Gamma Radiation compatible |
| Certifications | ISO 9001:2015, IATF 16949:2016 |
Scalpels, forceps, retractors, clamps, and cutting tools for surgical procedures
Joint replacement components, bone screws, plates, and spinal fixation devices
Dental hand tools, orthodontic components, and prosthodontic hardware
Stents, valve components, pacemaker housings, and surgical tools
Imaging machine components, lab equipment parts, and analytical instruments
Injector components, pump housings, and metering device parts
CNC Machines
Medical Precision
Fast Delivery (Days)
Certified QMS
ISO 9001:2015
IATF 16949:2016
ISO 14001:2015
We primarily machine 316L (low-carbon 316 for superior corrosion resistance), 17-4 PH (high-strength precipitation hardening), and 420 (high-hardenability martensitic) stainless steels. All materials comply with ASTM F899 standard for surgical instruments.
Yes, all our medical-grade stainless steel parts are manufactured from biocompatible materials and tested in accordance with ISO 10993 standards. We provide biocompatibility certificates and material traceability documentation.
Our medical-grade stainless steel parts are compatible with all common sterilization methods including autoclave (steam sterilization at 121-134°C), ethylene oxide (EtO) gas, and gamma radiation. Parts are designed to withstand repeated sterilization cycles without degradation.
Absolutely. Every medical-grade stainless steel component comes with complete material traceability including mill test reports (MTR), chemical composition analysis, mechanical testing certificates, and full batch traceability throughout the manufacturing process.
We have no minimum order quantity. Whether you need a single surgical prototype or high-volume production of implantable components, we can accommodate your requirements with the same quality standards and documentation.
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Get a free quote within 24 hours. ISO 9001 certified quality for medical device manufacturing.