Medical Device Enclosure and Housing Design
An enclosure has to do four things at once: protect the electronics, survive cleaning chemistry, look like a device a hospital trusts, and come apart for service. Sheet metal shops solve the third one last.
Enclosures we have designed
Console and cabinet for a dental laser surgery system
Wearable housing for a patient HOLTER monitor
Enclosure for a non-invasive neuromodulation system
Optical imaging system housing
Aesthetic treatment system enclosure
How we approach it
We design the enclosure and the chassis together, not the skin over someone else box. That means service access, thermal path, EMI containment, and part-to-part tolerance stack are settled in CAD before tooling, and that design for manufacturing review happens inside the design phase rather than as a separate invoice afterwards.
Designing an enclosure for IEC 60601-1
Mechanical safety under IEC 60601-1 lives mainly in two clauses. Clause 15 covers construction and mechanical strength; Clause 9 covers mechanical hazards, meaning instability, moving parts and trapping. Which tests apply depends on whether the equipment is hand-held, portable, mobile, stationary or fixed, and on its transport configuration as well as its operating one.
For an enclosure that means, at minimum: rigidity, so the enclosure withstands a 45 N applied force without a failure that compromises basic safety; impact, by hammer or ball drop at the vulnerable locations; moving parts, with no crush, pinch, shear or trap points through the full range of motion; and surface temperature limits at any touchable surface.
None of this is exotic. What makes it expensive is finding out late. A wall section that passes a 45 N push in one place and fails at a boss two inches away is a tooling change, not a CAD change, once the mould is cut. We design the load path and the fastening scheme with these clauses in view from the first CAD model, and we build physical parts early enough to push on them.
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