EMC requirements for an accessory to a medical device

  • Thread starter porscheuberalles
  • Start date
P

porscheuberalles

My company is designing a custom keyboard to be used with our diagnostic ultrasound device. 60601-1-2 states: "4.1.2 Electrical equipment that is not ME EQUIPMENT
Electrical equipment that is not ME EQUIPMENT and that is supplied as part of an ME SYSTEM is exempt from the EMC testing requirements of this collateral standard provided all of the following conditions are met (see also Annex G):
a) the electrical equipment that is not ME EQUIPMENT complies with applicable international EMC standards;
b) both the EMISSIONS and IMMUNITY of the electrical equipment that is not ME EQUIPMENT have been determined not to adversely affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM; and
c) the EMISSIONS of the electrical equipment that is not ME EQUIPMENT have been determined not to cause the EMISSIONS of the ME SYSTEM to exceed applicable limits."

My question is what EMC testing is required for the custom keyboard? Is there an applicable standard?
 
P

porscheuberalles

Bump. Anyone have experience with this particular issue?
 
P

Pads38

Moderator
No direct experience - but to start things of.

My thinking would be that the keyboard should be connected to your device for the EMC tests. I am assuming here that this would be the "normal" configuration of the ultrasound.

If, however, the keyboard is only connected during an initial set-up then, perhaps, separate testing may be reasonable. In this case I would look at the standards for IT equipment which (in Europe) would be IEC EN61000-6-4 for immunity and IEC EN55022 for emissions.

Possibly the best people to speak to are your EMC test lab, although I do think it is wise to try and understand the requirements your self, as you are doing. This has to be better than blindly handing over your device (and a blank cheque!) to the test house.
 
L

lu000583

sometimes its hard to meet b and c because its not easy work todetermine without test. keyboard is usually using cispr 22/24. i suggest use 60601-1-2 to test as system.
 
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