DIN EN 60601-1-2 applicability in the world and in the US

#1
Can any one tell me the applicability of this norm around the world. This is a european norm of medical electrical eqipment . It give a requirement of accompanied documents with medical electrical system .


Can anyone tell me that whether this norm is only applivale to EU or elsewhere around the world especially USA?

Thanks in advance
 
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T

temujin

#4
Hi,

I don´t know of any country that do not recognize the use of 60601-1-2.

However, if you test a product with respect to the standard and later decide to export the product to e.g. the US or Japan, you might need to re-do the tests using the correct mains supply and frequency.

You should first identify your marked and then check if any of these countries have any deviations to the standard.

regards
t.
 
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