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DFM Guide · Medical Cleanliness

Cleanable design.
No crevices.
Sanitary first.

Medical equipment must clean reliably between uses. Crevices, dead spaces, sharp internal corners harbor bacteria. Design for cleanliness from start.

01 · Key principles

Key principles.

No internal crevices

Drain everything

Avoid crevices, dead corners, hidden cavities. Design fully drainable.

Smooth surfaces

Cleanable Ra

Ra 0.4-0.8 µm typical for cleanability. Electropolished for highest tier.

Internal radii generous

No sharp corners

Internal corners radiused 3-5 mm minimum. Bacteria collect in sharp corners.

Sealed welds

No gaps

Sanitary welds — orbital TIG, smooth profile. No discontinuity for bacteria.

Smooth fastener heads

No recessed slots

Minimize fastener heads with recesses. Use button-head, smooth caps. Or bonded assemblies.

Material compatibility

Cleaning agents

Materials resistant to medical cleaning agents (alcohol, chlorhexidine, hydrogen peroxide).

FAQ

What's "medical clean"?

Defined per: ISO 17664 (sterilization processing), ISO 13485 (QMS), AAMI standards. Application-specific.

Reusable vs disposable?

Reusable: must withstand 100s of cleanings without degrading. Disposable: lower cleaning burden.

Sterilization compatibility?

Steam autoclave 121°C: most metals OK, most plastics struggle. Gamma radiation: most materials but check polymer effects.

Surface roughness?

Ra ≤ 0.8 µm general medical, ≤ 0.4 µm sterile applications. Electropolished for biopharm.

Gasket selection?

Silicone or Viton standard. Avoid gasket types that absorb fluids.

Disassembly for cleaning?

Yes — design for disassembly between uses. Snap fits or thumbscrews enable user disassembly.

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