Medical Parts We Machine
Representative medical part families from production under our ISO 13485:2016 certified system.
Part Families, Tolerances, Order Patterns
| Part family | Common materials | Key tolerances | Typical finish | Typical order |
|---|---|---|---|---|
| Endoscope tube components | SUS316L | ID/OD +/-0.01 mm, Ra 0.4 inner | Electropolish ready | 100 to 1,000 pcs |
| Surgical instrument handles and bodies | 17-4PH, 420 | +/-0.01 mm seats, HRC 40-50 | Passivation | 200 to 2,000 pcs |
| External fixator rods and clamps | SUS316L | +/-0.02 mm threads and seats | Passivation | ISO 13485 documented |
| Diagnostic device housings | 6061-T6, SUS304 | +/-0.05 mm general, +/-0.01 mm datum | Type II anodize / passivated | 500 to 5,000 pcs |
| Lab automation fixtures and carriers | 6061-T6, PEEK | +/-0.02 mm repeatability features | Clear anodize / natural | 100 to 1,000 pcs |
| Dental handpiece components | SUS303, 17-4PH | +/-0.01 mm, Ra 0.4 | Passivated | 500 to 5,000 pcs |
| Minimally invasive instrument tips | 316L, 420 | Edge and seat +/-0.01 mm | Passivated | 200 to 2,000 pcs |
| Implant-adjacent trial parts | Ti-6Al-4V (TC4) | +/-0.01 mm | Passivated, cleaned | 50 to 500 pcs |
| Diagnostic consumable carriers | 6061-T6, PEEK | +/-0.02 mm | Clear anodize / natural | 500 to 5,000 pcs |
| Surgical guide bases | PEEK, POM | +/-0.05 mm | Natural, cleaned | 100 to 1,000 pcs |
How to use this page: these are families we run repeatedly, so process risk is low and lead times are predictable. If your part is not listed, it is likely still in scope: send the drawing and we answer within 24 hours.
System background: our quality page covers the ISO 13485:2016 certified system.
Medical Parts FAQ
Which ISO 13485 scope covers these parts?
Our ISO 13485:2016 certificate (NQCC, cert 50526YY00027R000) covers medical device component machining; documentation per lot ships with the parts.
Do medical parts ship with full documentation?
Yes: material certificates, dimensional reports and cleaning records in English, filed per part number for repeats.
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