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AMPLETRON

Medical

Medical Device PCB CAM

Circuit boards for medical equipment like monitors and implants, where safety and reliability are tightly regulated because people's lives depend on them.

1 min readmedicaliso-13485iec-60601hdi
Outcome

Traceable, high-reliability boards that support device-file documentation and long product lifecycles.

Medical electronics span tiny implantable and wearable boards through large diagnostic instruments. What unites them is a regulated quality system and a low tolerance for field failure in life-affecting devices.

Quality system

  • ISO 13485 — the quality-management standard for medical devices; fabrication and CAM records feed the device master record.
  • IEC 60601 — safety and creepage/clearance requirements for medical electrical equipment, which drive spacing rules our DFM enforces.
  • IPC Class 2/3 depending on criticality — implantable and life-support hardware typically Class 3.

Density and reliability

Wearables and implantables push HDI and microvia density hard, while diagnostic instruments demand signal integrity for high-speed data. We balance:

Device classCAM priority
ImplantableMiniaturization, biocompatible finish
WearableHDI density, flex/rigid-flex
DiagnosticSignal integrity, controlled impedance
InstrumentReliability, serviceability

Creepage and isolation

Patient-connected circuits require isolation barriers with defined creepage and clearance. Our DFM checks these spacings against IEC 60601 working-voltage tables, not just the fab's manufacturing minimum.

Engineering noteThe manufacturing minimum spacing and the safety-required creepage are two different constraints — a board can be perfectly fabricable and still fail a 60601 isolation review. We check both.

Every job is delivered with a documented netlist and DFM record suitable for inclusion in the device file, supporting the long, audited lifecycle medical products require.

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