ISO9001/IATF16949 Certified CNC Manufacturer in China | 24h Quotation | Free DFM Support
Precise. Clean. Traceable. SPI™ supports ISO 13485–aligned machining & molding workflows for medical devices and instruments. From micro Swiss‑type shafts to 5‑axis titanium implants and injection‑molded housings, we deliver burr‑free edges, validated cleaning, and lot‑level documentation.
✅ ISO 13485–aligned workflows
✅ Cpk ≥ 1.67 on CTQs (mass production)
✅ DHR & lot-level traceability
Surgical & Implant Metal Parts
Ti-6Al-4V, 316L, 17-4PH, Co-Cr; small shafts, bone screws, jaw sets, fixtures.
→ 5-Axis CNC machining for surgical parts: https://super-ingenuity.cn/5-axis-cnc-machining/
→ Swiss-type micro-machining for implants: https://super-ingenuity.cn/swiss-lathe/
Plastic Housings, Fixtures & Prototyping
Medical housings, ergonomic handles, jigs & fixtures, pilot runs.
→ Injection molding for medical housings: https://super-ingenuity.cn/injection-molding/
→ Rapid tooling for pilot runs: https://super-ingenuity.cn/rapid-tooling/
→ Medical 3D printing prototypes: https://super-ingenuity.cn/3d-printing/
→ Medical-grade vacuum casting: https://super-ingenuity.cn/vacuum-casting/
Sheet/Plate & Pre-form Workflows
Laser-cut blanks, cast-to-machine aluminum, then precision finishing.
→ Medical laser cutting of 316L/PEEK sheets: https://super-ingenuity.cn/laser-cutting/
→ Sand casting aluminum blanks for machining: https://super-ingenuity.cn/sand-casting/
Surgical instrument components (jaws, clamps, handles) — burr-free edges, polishing-ready.
• Micro shafts, guidewires, mandrels, pins; bone screws & connectors with tight concentricity.
• Pump/valve bodies, manifolds, sensor mounts requiring multiface tolerances.
• Plastic housings for handheld devices, fixtures & jigs for assembly/validation.
• Prototype enclosures and bridge builds before hard tooling.
• Laser-cut 316L/PEEK sheet features prior to finish machining.
| Material | Typical medical use | Key machining notes | Common finishes (impact) |
|---|---|---|---|
| Ti-6Al-4V (incl. ELI) | Implants, lightweight instrument parts | Watch galling; polish mating faces | Color anodize for ID (no structural change); mech. polish → Ra ≤0.4 µm |
| Ti-6Al-7Nb | Vanadium-free implant specs | Similar to Ti-6Al-4V | Same as above |
| 316L stainless | Surgical tools, housings | Stable, corrosion-resistant | Passivation (no buildup); Electropolish (removes 5–25 µm; Ra ↓30–60%) |
| 17-4PH stainless | Clamps, hinges, shafts | Heat treat H900–H1150 | Passivation; electropolish where geometry allows (stock removal 5–25 µm) |
| 6061 aluminum | Enclosures, fixtures | Good machinability | Anodize Type II ~5–25 µm (≈½ penetration/½ buildup) |
| 7075 aluminum | High-strength frames | Rigid fixturing | Hardcoat Type III ~12–75 µm (mask tight bores/threads) |
| Co-Cr alloys | Wear/arthro surfaces, dental | Tough; small stepovers, sharp tools | High polish for articulation (low Ra) |
| Material | Typical use | Sterilization/chemistry | Machining/design notes |
|---|---|---|---|
| PEEK | Implantable components (per spec), structural housings | Steam/EtO/gamma tolerant | Pre-dry; allow for thermal expansion; stress-relieve after machining |
| PEI (Ultem) | High-temp fixtures, semi-transparent covers | Steam/EtO tolerant | Good stability; consider wall ≥1.5 mm for housings |
| PPSU | Reusable handles, trays | Excellent repeated steam | Tough; fillets for stress relief; good chemical resistance |
| PTFE | Low-friction seats, liners | Broad chemical tolerance | Creep/cold-flow—use larger bearing areas, avoid tight load-bearing fits |
| PC/ABS | Handheld housings, ergonomics | EtO/low-temp preferred (steam not ideal) | Impact-resistant; avoid harsh solvents; cosmetic textures acceptable |
| PMMA | Clear windows, light guides | Limited to non-repeated steam | Polishable; avoid stress-cracking—gentle cleaners only |
| Finish | Applies to | Purpose | Dimensional / surface impact | Notes |
|---|---|---|---|---|
| Passivation | Stainless | Restore corrosion resistance | No measurable buildup | Run after machining/blasting; improves cleanability |
| Electropolishing | Stainless | Smooth peaks, reduce Ra | Removes 5–25 µm; Ra ↓30–60% | Specify protected zones; improves sterilization outcomes |
| Anodize Type II | Aluminum | Corrosion, color ID | ~5–25 µm (≈½ penetration/½ buildup) | Mask threads/CTQs; optional seal |
| Anodize Type III (Hardcoat) | Aluminum | Wear protection | ~12–75 µm (growth affects fits) | Plan tolerances; typically sealed |
| Black Oxide | Steel/SS | Low-glare, mild protection | Minimal change | Often oil-finished if allowed |
| Bead/Glass Blast | Metals | Matte/glare reduction | Ra increases | Follow stainless blasting with passivation |
| Laser Marking | Metals (esp. 316L, Ti, anodized Al) | UDI/traceability | Nil to slight (annealed marks best for 316L) | Validate legibility after sterilization |
| Mechanical Polishing | Metals | Cosmetic & low-Ra faces | Removal varies; Ra ≤0.4 µm achievable | Define zones & target Ra |
| PVD/DLC (opt.) | Steel/SS | Wear & friction reduction | ~1–4 µm added | Mask CTQs; re-verify dimensions |
| Feature type | Typical capability | Validated (on defined CTQs) | Notes |
|---|---|---|---|
| Linear / hole size | ±0.01 mm | ±0.002 mm | Depends on geometry, fixturing, tool reach, material stability |
| True position | ±0.02 mm | ±0.005–0.010 mm | With datums & 5-axis/fixture strategy |
| Flatness / parallelism | 0.02 mm | 0.005–0.010 mm | Plate size & clamping strategy dependent |
| Roundness / cylindricity | 0.01 mm | 0.003–0.005 mm | Validated with roundness tester/CMM |
| Surface roughness (Ra) | 0.8–1.6 µm machined | ≤0.4 µm (polish/electropolish) | Specify function-based RA targets |
| Threads (metric/UNF) | Go/No-Go per print | Class-specific validation | ISO metric 6H/6g, UN/UNF 2B/2A gauges |
| Micro features | Pins/slots ≥Ø0.5 mm | Tighter on request | Requires microscope verification |
| Wall thickness (Ti/PEEK) | ≥0.5–1.0 mm typical | Case-by-case | Account for heat, stress relief, cleanup stock |
| Instrument | Purpose | Typical range / resolution | When we use it |
|---|---|---|---|
| CMM | 3D GD&T, true position | µm-level, program-driven | FAIs, CTQs, PPAP/validation lots |
| Optical vision system | Micro-feature measurement | Sub-10 µm | Slots, micro holes, edges, plastic features |
| Surface profilometer | Ra/Rz verification | Ra down to ≤0.1 µm | Mating faces, polished/electropolished zones |
| Roundness/cylindricity tester | Form errors on shafts/bores | µm-level | Swiss-type shafts, bearing fits |
| Height gauge / granite | Datum heights, steps | 0.001 mm increments | Fast in-process checks |
| Bore gauges / pin gauges | Bore size verification | Class-fit pins | Tight bores, post-finish checks |
| Thread gauges (metric/UNF) | Go/No-Go acceptance | Class 6H/6g; 2B/2A | Metal & plastic threads per spec |
| Hardness tester | HRC/HB | — | Heat-treated 17-4PH, others |
| Microscope (≥40×) | Edge/burr inspection | — | Micro-deburr acceptance |
| Coating thickness (as needed) | Anodize/hardcoat checks | µm-level | Confirms buildup/penetration on Al |
| Topic | Target / practice | Notes |
|---|---|---|
| Sampling & AQL | Customer spec or internal plan | Defined at RFQ/PO; CTQs elevated |
| SPC charts | X̄-R / X̄-S on CTQs | Continuous for mass production |
| Process capability | Cpk ≥ 1.67 on CTQs | Start-up may run at 1.33 during stabilization |
| MSA / GR&R | ≤10% preferred, ≤20% acceptable | On gauges used for CTQs |
| First Article | FAI per drawing/ballooned report | PPAP/ISIR available on request |
| Gauge calibration | Scheduled cycle with records | Stickers + certificates tracked |
| Nonconformance | NCR + corrective action (8D if req.) | With customer approval for disposition |
| Cleanliness validation | Post-clean checks per SOP | Links to cleaning & packaging records |
| Document | What it includes | Default / Optional |
|---|---|---|
| Dimensional report (CMM/vision) | Ballooned features, CTQ results, instruments | Default for CTQs; full on request |
| Material certificate | Heat/lot traceability (e.g., EN 10204 3.1) | Default |
| Finish certificate | Passivation/electropolish/anodize parameters | As required |
| Surface finish record | Ra/Rz readings at defined zones | As required |
| Heat-treat certificate | Condition (e.g., 17-4PH H900) | As required |
| Packaging release note | Lot/serial IDs, counts, inspector sign-off | Default |
| DHR / lot traceability sheet | PO → heat lot → process cards → inspections → release | On request |
| Certificate of Conformance (CoC) | Conformance statement to print/spec | Default |
Validated cleaning (ultrasonic + DI rinse; IPA/solvent where appropriate) with controlled drying.
Cleanroom-friendly packaging with anti-static liners, desiccant & vacuum bags, ESD/sterile labels, and lot/serial IDs for DHR.
Stainless instruments can receive passivation and electropolishing. For polished parts, specify target Ra (e.g., instrument mating faces ≤ 0.4 µm).
Workflows align with ISO 13485 principles on risk, traceability, and change control (official overview: https://www.iso.org/standard/59752.html)
For the U.S. market, we follow FDA Quality System Regulation (21 CFR Part 820):
We support DHF/DHR, COC for materials/finishes, and RoHS/REACH statements on request.
Use blend radii ≥ 0.2–0.5 mm instead of sharp internal corners to aid cleaning and burr control.
• Avoid dead-end grooves; design through-wash paths for validated cleaning.
• For micro-threads, specify class and gauge type; agree on go/no-go acceptance at RFQ.
• For PEEK/PPSU, plan post-machining stress-relief/ageing to withstand sterilization cycles.
• Define CTQs early with SPC sampling; tie surface targets to function (e.g., mating faces Ra ≤ 0.4–0.8 µm).
Q1. Can you provide ISO 13485 documentation & DHR traceability?
Yes—ISO 13485–aligned documentation packs with lot-level DHR, plus material/finish certificates.
Q2. How do you validate cleaning & packaging?
Ultrasonic + DI with controlled drying; desiccant/vacuum packaging and serial/lot labels; passivation/electropolish where required.
Q3. What surface roughness can you achieve on surgical instruments?
Machined Ra 0.8–1.6 µm is typical; with polishing/electropolishing, ≤ 0.4 µm can be targeted depending on geometry.
Q4. Can you machine PEEK and PPSU for sterilization cycles?
Yes—we routinely machine PEEK/PEI/PPSU and advise on radii, wall thickness, and stress-relief.
Q5. Do you handle both prototypes and mass production?
Yes—from one-off validation to CPK-controlled mass production with clean packaging and labeling.
Quality Manager — ISO 13485 documentation, DHR compilation, SPC/CPK dashboards
Manufacturing Engineer — 5-axis titanium & Swiss micro-turning process planning; deburr/cleaning validations
Inspection Lead — metrology programs (CMM/vision/roughness), gauge calibration
CNC Machining Design Guide
Discover How SPI ™Super-ingenuity Delivers Precision CNC Machining for High-Performance Prototypes and Production Parts
