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.
Best regards
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.

Best regards