Product Parameters
| Item | Specification |
|---|---|
| Material | Stainless Steel (303, 304, 316, 17-4 PH), Titanium, Aluminum |
| Tolerance | ±0.02 mm standard |
| Surface | Electropolished, Passivated, Ra 0.2 μm |
| Quality | ISO 13485, FDA Compliant |
| Application | Surgical instruments, diagnostic equipment, implantable devices |
| MOQ | 10 pcs |
description
Medical machined components serve surgical instruments, diagnostic equipment, and in some cases implants themselves - applications where dimensional accuracy, surface finish, and material traceability are tightly regulated. A surgical instrument that fails or a diagnostic component that gives inaccurate readings can have serious consequences. 303 and 304 stainless steel handle most surgical instruments and diagnostic equipment. 316 stainless takes on more corrosive environments including steam sterilization. 17-4 PH precipitation-hardened stainless provides higher strength for load-bearing applications. Titanium alloys are used where strength-to-weight ratio matters and biocompatibility is required. Surface finish is not cosmetic in medical applications - it affects cleanability, biocompatibility, and corrosion resistance. Electropolishing removes surface imperfections and creates a smooth, contamination-resistant finish that is easier to clean and less likely to harbor bacteria.
Why Surface Finish Affects Biocompatibility
Bacteria adhere more readily to rough surfaces - the microscopic peaks and valleys provide hiding places that cleaning cannot reach. An Ra 0.2 μm electropolished surface is smooth enough that bacteria have nowhere to hide. For implants that remain in the body, this difference is significant. For surgical instruments that go through repeated sterilization, it affects how reliably the instrument can be cleaned between uses.
FAQ
Q1: MOQ?
A1: 10 pieces.
Q2: Quality systems?
A2: ISO 13485 and FDA compliant quality systems.
Q3: Materials available?
A3: 303, 304, 316 stainless, 17-4 PH, titanium alloys, aluminum.
Q4: Surface finishes?
A4: Electropolishing and passivation standard. Ra 0.2 μm surface finish available.
Q5: Traceability?
A5: Yes. Material certificates, heat treatment records, inspection reports included.
Q6: Custom components?
A6: Yes. Surgical instruments, diagnostic components, implant-adjacent parts.
Quality is non-negotiable in precision manufacturing. Every component undergoes rigorous inspection at each stage of production.
- ISO 13485 - Full FDA compliance support; quality management system for medical device components
- ISO 11607 / FDA 21 CFR 820 - Packaging and sterilization validation for implantable and surgical devices
- ASTM F136 / F67 - Material specification compliance for implant-grade titanium and stainless
- First Article Inspection (FAI) - Full dimensional and functional report for every medical component
- CMM Inspection - Coordinate measuring for complex geometries and tight tolerances
- Surface Roughness Measurement - Ra, Rz, and Rt charting with every inspection report
- Passivation / Electropolishing - ASTM A967 procedures for corrosion resistance
- Material Traceability - Heat number tracking from raw material to finished part
From raw material to finished product, every step is controlled and documented:
- Material Verification - Incoming material inspection with mill certificates
- Rough Machining - CNC turning/milling to near-net shape
- Heat Treatment - Hardening, annealing, or surface treatment as required
- Finishing Machining - CNC finishing, grinding, or precision machining
- Surface Treatment - Plating, anodizing, polishing, or coating as specified
- Inspection & Testing - Dimensional check, hardness, and surface measurement
- Cleaning & Packaging - Degreasing, rust prevention, and protective packaging
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