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What standards should be applied for labeling grounding requirements on medical devices?

Susan asks this question regarding a grounding label for a saline pump in a medical
device.

Thanks Susan for your excellent question regarding grounding labeling requirements on medical devices. As we are sure you are aware, there are numerous standards governing medical device labeling and documentation, particularly if you are in the state of California. While we can make no specific claims of expertise in Medical Device labeling, we were able to find a number of standards that may better answer your question:

  • 21 CFR 801
  • ISO 15223:2000
  • EN 980
  • EN 46000
  • CE Directive 93
  • IEC 60601-1

Surely these are only a few of the standards and regulations that may be applicable to your case. However with that said, we are not aware of any particular code, standard or regulation that dictates labeling requirement specifically for electrical grounding, although it is quite possible we have simply not run across it yet.

Certainly there are some general rules for human safety that must apply, such as informing the user that the system must be grounded for safe operation, or if the unit must be placed on a GFCI circuit, or if the system requires isolated grounding, or if you require 5-ohm or less grounding systems. Clearly, if these special grounding systems are required for the safe and reliable operation of the equipment, the end user must be properly notified. But as far as we are aware, the manufacturer must make that determination, there is no standard or code that we are aware of that will determine this for you.

Best regards,
The E&S Grounding Solutions Engineering Team

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