Industry: medical devices (non-implantable)
Precision CNC machined parts for medical devices
Medical device manufacturers need biocompatible materials, validated processes, and full traceability. Boyang machines stainless 316L, aluminium 6061/7075, and engineering plastics for non-implantable medical device housings, instrument chassis, mounting brackets, and sterilisation-tolerant parts.
Boyang supplies precision CNC parts for non-implantable medical devices, including instrument housings, mounting brackets, sterile-zone chassis, and optical-mechanical assemblies. Material selection and surface finish are driven by the device’s cleaning or sterilisation method (IPA wipe-down, autoclave, EtO, gamma). Material certificates and first-article reports are provided as default documentation.
Compliance status: ISO 9001:2015 (Declared). ISO 13485 is not held by Boyang; medical device manufacturers handle ISO 13485 system compliance at the finished-device level. Parts labelled "for medical device OEM use" are supplied under the OEM’s quality system, not Boyang’s.
Typical parts and use cases
| Part type | Typical requirement |
|---|---|
| Diagnostic instrument housings | Handheld and benchtop device shells; aluminium 6061 with Type II anodising for cosmetic finish. |
| Sterilisation-tolerant components | Stainless 316L parts rated for autoclave (134 °C / 30 min) or EtO; passivated per ASTM A967. |
| Optical bench and chassis components | Aluminium 7075 for stiffness; datum faces flat to ≤0.02 mm. |
| Mounting brackets and clamps | Stainless 316L or anodised aluminium; bolt-circle true position ±0.05 mm. |
| Knobs, levers, and operator interfaces | Engineering plastics (POM, PA66, PEEK) machined with cosmetic finishes. |
Material and finish guidance by sterilisation method
| Sterilisation method | Recommended material and finish |
|---|---|
| IPA wipe-down / ambient cleaning | Aluminium 6061/7075 with Type II anodising; stainless 316L with passivation. |
| Autoclave (134 °C steam) | Stainless 316L only; passivated; design for drainage to avoid liquid retention. |
| Hydrogen peroxide / VHP | Stainless 316L passivated; avoid crevices; surface Ra ≤0.8 (µm) on sealing faces. |
| Gamma irradiation | Stainless 316L; engineering plastics validated per the polymer supplier (which the plastic tolerates gamma). |
| EtO sterilisation | Stainless 316L passivated; aluminium with anodising; ensure aeration path for polymer parts. |
Capabilities used in this industry
- 5-axis CNC machining
- CNC turning (Swiss-style available)
- Anodising Type II
- Passivation (ASTM A967)
- CMM inspection
- Clean-pack assembly
Related case study
- Medical instrument manufacturer — Instrument housing and mounting bracket machined for a medical OEM.
Frequently asked questions
Is Boyang ISO 13485 certified?
No. Boyang is ISO 9001:2015 certified. ISO 13485 is held at the finished-device manufacturer level. We supply parts under the customer’s quality agreement, which typically references the customer’s ISO 13485 system.
Can you provide material certificates with each batch?
Yes. Mill certificates are provided by default for stainless 316L orders and on request for aluminium stock.
What surface finish do you recommend for parts cleaned with IPA?
Anodised aluminium (5–25 µm Type II) or passivated stainless 316L (Ra ≤0.8 µm) are both compatible with repeated IPA wipe-down. Avoid bare aluminium or zinc-plated steel.
Do you support gamma or EtO sterilisation validation?
Boyang does not perform sterilisation validation; this is the responsibility of the finished-device manufacturer. We supply parts with the material certifications needed for your validation protocol.
Can parts be supplied clean-packed?
Yes. Clean-room bagging (ISO Class 7 or 8) is available by arrangement for medical orders.
Request a quotation for medical devices
Send drawings in STEP, IGES, or PDF with tolerances and inspection points. We respond with material options, lead time, and unit price within 2 business days.