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IEC 60601 and the UL mark

invitro_spain

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#1
Dear all,

I have a doubt about a medical device labeling in regards to the IEC 60601 and the UL Mark.
Is it mandatory to include the UL mark on the product, on the label, in relation to the standards applied? or Can it be included in the IFU and avoid using it on the product label?
Is it only a UL requirement or mandatory in any case?

Thank you in advance
 
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shimonv

Trusted Information Resource
#3
In the US, your product has to be certified by one of the nationally recognized test laboratories (NRTL), and as a sign of conformance their mark appears on the device label.

Every market has its own nuances. In the EU there is no such requirements; in Korea there is a different mark..


Cheers,
Shimon
 
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