1. Background introduction

In the medical field, the entrance window is an important device for interventional small-scale fully magnetic levitation artificial heart, which has strict processing requirements for materials and appearance. This case study shows the company's successful experience in processing entrance windows using fully automatic CNC lathe. SUS316 has become the preferred material for medical interventional materials due to its excellent corrosion resistance, mechanical properties and biocompatibility, high strength, light weight and easy processing.

2. Material and technical challenges

The main processing challenges of SUS316 material include:

Material selection: This type of part has high requirements for appearance (no scratches, gravures, sand holes and other defects are allowed inside and outside the product, and the roughness requirement is Ra0.4).

Structure is easy to deform: This type of part has thin wall thickness and ribs and hollow inner holes. The product has deformed and vibrated during the processing. Especially when manufacturing high-precision medical devices.

High surface treatment: deformation and dimensional deviation are prone to occur during polishing, so the polishing method, polishing material selection, and polishing tooling production are required.

High strength and toughness: This increases the cutting force and tool wear during processing.

Therefore, processing such parts requires high-precision equipment and strict process control. Fully automatic core-walking machine CNC lathe can provide advantages in these aspects, including reducing the errors caused by multiple clamping and being able to complete the processing of complex curved surfaces in one go.

3. 5 Advantages of fully automatic core-walking machine CNC lathe processing

Shiyuxiang introduced advanced fully automatic core-walking machine CNC lathe processing, the main advantages include:

• High-precision processing: The fully automatic core-walking machine CNC lathe adopts a rigid structure and a precision guide system, which can achieve micron-level (even sub-micron-level) processing accuracy. Application and parts with extremely high requirements for processing dimensional accuracy, shape accuracy and surface finish.

• High-efficiency production: The fully automatic core-walking machine CNC lathe can complete multiple processes in one clamping, reducing the number of workpiece clamping and processing time, improving processing efficiency and reducing potential errors.

• Complex parts processing capability: The fully automatic CNC lathe is equipped with multi-axis linkage function, which can process parts with complex geometric shapes.

• High degree of automation: The fully automatic CNC lathe can be equipped with an automatic feeder, which is suitable for 24-hour continuous production, reducing labor costs and improving production stability.

4. Processing process

In order to ensure the accuracy and appearance quality requirements of the entrance window, Shiyuxiang Precision follows the following processing steps:

1. Design and programming: According to the 2D and 3D drawings provided by the customer, Shiyuxiang's engineering team programs the processing path of the part in detail, especially the curved surface part, to ensure the consistency of the processing path with the design.

2. Roughing and finishing: Use the fully automatic CNC lathe for processing, one-time molding, to ensure the required dimensional accuracy and surface finish.

3. Surface treatment: In order to meet the strict requirements of medical devices, the entrance window is surface treated, deburred and polished after processing to ensure that its surface is smooth and defect-free.

5. Quality control

In the production of medical devices, quality inspection is crucial. In order to ensure the performance of the entrance window, Shiyuxiang Precision has implemented the following quality control measures: Dimension detection: Use a high-precision 2.5-dimensional, electron microscope to detect the key dimensions of the entrance window to ensure that it meets the design tolerance requirements.

Surface quality detection: A high-power microscope is used to check whether the surface has burrs, pits, sand holes, steps or other defects that may affect the safety of intervention.

6. Compliance requirements of the medical industry

As a medical device, the production of the entrance window must meet strict industry standards. Shiyuxiang Precision also has the ISO 13485:2016 medical device quality management system certification. Shiyuxiang Precision strictly follows the ISO 13485:2016 medical device quality management system to ensure that every link from material procurement, processing to testing meets the standards. In addition, the entrance window must pass a series of biocompatibility tests to ensure its safety and stability in the human body.

7. Conclusion

Through this case study, it can be seen that Shiyuxiang Precision successfully used Swiss-type machining technology to solve the difficulties in the processing of various parts of the interventional small-scale fully magnetic levitation artificial heart, ensuring the high standards of the entrance window in terms of biocompatibility, mechanical strength and surface quality. This case not only demonstrates Shiyuxiang Precision's technical strength in the processing of difficult materials, but also shows that it has excellent experience and capabilities in the field of medical device manufacturing, providing customers with products that meet the strict requirements of the medical industry. It also highlights Shiyuxiang Precision's innovative ability in the medical field