Harmonized standard of EU---EN 60601-2-10:2000/A1:2001

O

Onion_Mr

Registered
#1
#1
Hello All;
Question is coming again!!!!
IEC has published 60601-2-10 ed.2 (2012), CEN has not published equivalent standard yet (EN 60601-2-10:2015 being projected). OJ has accepted EN 60601-2-10:2000/A1:2001 as harmonized standard under directive many years ago. As you know, EN 60601-2-10 ed.1 is too old to use, which obey the rule of the state of the art.
My question is:
We have a TENS product. Can we adopt IEC 60601-2-10 ed.2 (2012) directly to meet ER of directive? Nor the EN 60601-2-10:2000/A1:2001.
I appreciated someone can help this.:applause:
Best regards
 
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M

Marcelo

Inactive Registered Visitor
#2
#2
You can (you can use any standard in fact), but in this case you do not gain presumption of conformity because the standard is not harmonized, so you have the burden to prove that the standard does fulfill the essential requirement (this can usually be done thru risk management).
 
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