Medical Devices and Implant Parts

Precision machining technology for Medical Devices and Implant Parts, with its micron-level precision control, ability to form complex geometries, and stable process repeatability, has become a core supporting technology for the manufacturing of medical device and implant components. These components are directly related to the accuracy of medical diagnosis, the safety of surgical procedures, and the long-term compatibility of implants with the human body. Their manufacturing process must simultaneously meet mechanical performance, biocompatibility, and stringent industry regulatory requirements, making it a key sub-field in the high-end medical manufacturing sector.

Technology Category

CNC-machined Medical Devices and Implant Parts encompass two main categories: "non-implantable" and "implantable." The former is the functional core of medical devices, while the latter is a "life support component" that replaces damaged human tissue. In the field of diagnostic equipment, its precision determines the operational stability of CT rotary bearings and the magnetic field uniformity of MRI gradient coils; in the field of implants, its geometric precision directly affects the lifespan of artificial joints and the osseointegration effect of dental implants. Data shows that implant components manufactured using CNC precision machining have a clinical complication rate that is more than 60% lower than those manufactured using traditional methods, while simultaneously increasing the localization rate of core components for high-end medical equipment to 45%.

Key Material Properties and Machining Compatibility

Material selection is the primary step in the CNC machining of Medical Devices and Implant Parts. It must simultaneously meet three major requirements: biosafety, mechanical compatibility, and machining feasibility. The mainstream materials and their compatibility characteristics are as follows:

1. Metallic Materials: Core Carrier for Implants

- Titanium Alloy (Ti-6Al-4V and ELI grade): As the preferred material for orthopedic and dental implants, it boasts a tensile strength of 860MPa and a density of only 4.5g/cm³, combining high strength with lightweight advantages. Furthermore, it exhibits excellent biocompatibility, forming a stable bond with human bone. During CNC machining, diamond-coated tools (wear rate ≤5μm/h) must be used, coupled with a spindle speed of 8000-12000rpm, to avoid tool sticking issues caused by poor thermal conductivity of the material, ensuring thread and surface accuracy.

- Cobalt-Chromium Alloy (CoCrMo): Suitable for friction interface components of artificial joints, its wear resistance is three times that of titanium alloy, and its corrosion resistance meets ISO 10993 standards. Five-axis CNC machine tools, through constant tool contact angle machining, can control the surface roughness to Ra≤0.4μm, reducing the generation of wear particles during joint movement.

- 316L stainless steel: Used for shaft components of surgical instruments and connectors for dialysis equipment. With a carbon content ≤0.03%, after CNC machining and passivation treatment, a stable oxide protective layer is formed, providing resistance to body fluid corrosion for over 10 years. During machining, a magnetic chuck is used for non-destructive clamping, along with medical-grade coolant to avoid surface contamination.

2. Polymer materials: Preferred for functional components

- PEEK (Polyetheretherketone): Its radiolucent properties make it an ideal material for spinal fusion devices, avoiding interference from metal implants in postoperative imaging diagnosis. CNC machining uses a vacuum adsorption fixture (positioning accuracy ≤±2μm), and micro-cutting (depth of cut ≤0.05mm) controls material thermal deformation, ensuring the intervertebral fitting accuracy of the fusion device.

- PTFE (polytetrafluoroethylene): used for syringe pistons and tubing seals. During CNC turning, the feed rate needs to be reduced to 0.01-0.03 mm/rev to achieve a surface accuracy of Ra≤0.2μm, reducing drug residue and pushing resistance.