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Build-in medical product design for the 60601 standard - check list for system engineers.

Several tips from the experience of "EMC Engineering Lab".

  • Touch screen - medical grade only (see the performance comparison of EMC test results in "industrial" and "medical" grade screen of the same producer in the picture below).

  • AC/DC PS - medical grade only (low EMC noise for class B products)

  • Modular AC/DC PS is better than multiple power supplies connected in parallel after medical transformer isolation (to reduce current leakage)

  • DC/DC - medical grade only, NO self-depeloping for class B products.

  • Fans, pumps, cooling elements - DC only and with CB reports.

  • Inlet AC filter - must, medical grade.

  • Cables - shielded and grounded on power, drivers, high RF signals, etc.

  • Generally use only recognizedand well-known parts suppliers with all relevant medical standards approvals.

  • Pre-compliance tests - mandatory, on the first HW design (CE, RE must - ESD, RI nice to have).

  • Emergency stop button on front panel of the machine.

  • Key for powering up the machine - can't be removed from the key house when machine is working – user needs to turn the key to the off position to remove the key.

  • All high power cards in metal grounded boxes.

  • Labels

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