Hello,
Reference Link
Is it me or is the setup (and notes) of the Office Journal for the harmonized standards falling under medical devices just plain confusing with regards to when conformity to a particular spec is REQUIRED?
Question 1) Is it still acceptable to have a product on the market (that was tested by a main test house in June 2007) which lists that the standard used for EMC was EN 60601-1-2:2001?
On another note:
From my understanding compliance with:
EN 60601-1-2:2007 and 60601-1:2006 will be required june 2012 (assuming all of the 61000 series can be updated)... is this correct?
Thanks for your time
qu1nn
Reference Link
Is it me or is the setup (and notes) of the Office Journal for the harmonized standards falling under medical devices just plain confusing with regards to when conformity to a particular spec is REQUIRED?
Question 1) Is it still acceptable to have a product on the market (that was tested by a main test house in June 2007) which lists that the standard used for EMC was EN 60601-1-2:2001?
On another note:
From my understanding compliance with:
EN 60601-1-2:2007 and 60601-1:2006 will be required june 2012 (assuming all of the 61000 series can be updated)... is this correct?
Thanks for your time
qu1nn