Machinery Equipment Parts

Why choose us?

1. Medical grade material certification

It is made of 316L VM stainless steel (ASTM F138 standard) and has passed the biocompatibility test of ISO 10993 to meet the requirements of implant grade

Optional titanium alloy (Gr5/Gr23) or cobalt-chromium alloy (ASTM F75), with Material report (MTC) and FDA 510k certification support

2. Micron precision control

Dimensional accuracy up to ISO 8062 CT5 level (±0.1mm/100mm)

Minimum feature size 0.3mm (such as microporous, thin-wall structure), surface roughness Ra≤1.6μm

3. Complex structure integration molding

Can cast orthopedic joint surface, dental implant thread and other complex geometry

It supports non-machinable structures such as inner cavity flow channel and special orifice channel

4. Whole process traceability system

Laser marking unique product identification

Clean workshop production according to GMP standard (Class 10000)

Product introduction

The product focuses on the manufacturing of precision castings in the medical field, using 316L VM medical stainless steel (ASTM F138 standard) and titanium alloy and other biocompatible materials, through the 9-layer silica sol investment casting process to achieve 0.3mm ultra-thin wall complex structure molding, the dimensional accuracy of ISO 8062 CT5 (±0.1mm/100mm). After vacuum centrifugal casting (density ≥99.5%) and hot isostatic pressing treatment, combined with electrolytic polishing (Ra≤0.2μm) and Swiss precision machining (roundness ≤0.005mm), the product perfectly meets the strict requirements of biological safety and functional precision of orthopedic implants, dental implants and other medical devices. We provide medical grade solutions for the whole process from raw material certification (FDA 510k) to GMP standard production.

Our advantage

1. Precision investment casting

Silica sol + zirconium sand composite shell (9 layers coating), type shell temperature 1600℃

Vacuum centrifugal casting, casting density ≥99.5% (X-ray testing ASTM E155)

2. Special post-treatment

Electrolytic polishing (EP) : The surface Ra value is reduced to 0.2μm to eliminate micro-cracks

Hot isostatic pressing (HIP) : 1000℃/100MPa treatment, close the internal micropores

3. Micron level finishing

Swiss precision lathe machining key mating surface (roundness ≤0.005mm)

Five-axis laser cutting fine structure (incision width ≤0.1mm)

4. Medical exclusive testing

3D blue light scanning (accuracy ±0.01mm) full size comparison

EDS spectrum analysis ensures no precipitation of heavy metals

Cleanliness test (Residual particles ≤0.5mg/cm²)

Detail data

FAQ

1.What is the Minimum Order Quantity?

5~1000 pcs. And we also accpet sample orders.

2. Can you manufacture according to customer's samples?

According to samples, we can make drawing, tooling and sample

3.How long will it take to make new samples according to customer's drawing or sample?

Totally 20 days. 10 days for tooling and another 10 days for sample.