Items to look out for when designing PC-based medical devices.
Does your device have more than one power cord?
If it does, you need to include a power strip that meets 60601-1 and 60601-1-2 EMC standards. The testing laboratory will be testing the device with the power strip as part of the device. They will also test the device with only some power cords plugged into the power strip. Be sure to check your EMC for each of these cases, as this can cause different emissions than planned.
Do you have multiple cords connected to your device?
Check with each cord disconnected and see what EMC radiation you have. The testing laboratory will check all the configurations of the cables being plugged into your device. We have seen customers get held up for months with this minor issue as they resolve the problem and then return to EMC testing.
Be aware that a change in components may affect your EMC emissions and require you to go back through EMC testing and approval. Check with your vendor for how long they plan to produce your specific model and choose components with long production lives.
Does your medical device plan go onto a medical cart?
Make sure your device and/or cart have a ground lug. Many older hospitals, especially in Europe, do not have a ground as part of their plugs. The hospitals have been retrofitted to allow carts and medical devices to be connected to a special ground run throughout the hospital. This is connected to the ground lug that is required to be placed on the carts.