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Hi everyone,
I am working on my device labeling (a small electronic medical device) and one of the IEC 60601-1
collateral standards has a requirement to put certain information on the enclosure of the ME equipment. There is no exclusion in the collateral, so basically the requirement is that the information is on the enclosure, period (not on the packaging or user manual).
The general standard does have a general exclusion in regards to placement of the information on labeling in subclause 7.2: that if the device is small then you can place information on the packaging and/or other labeling (unless it's in certain subclauses of 7.2; but this information is not one of those mandatory to be on the device itself in the general standard so we are including it in our user manual).
Does the exclusion of the general standard apply to the collateral too?
OR, since the collateral standard does not have its own exclusion for where to place the information, is it mandatory to have the collateral information on the device itself (i.e. the enclosure)?
Thank you!