Hi Everyone,
I'm trying to get my head around how versions of collateral and particular standards of relate to the general 60601-1 version...
Is there a simple relationship?
For example:
Europe currently has "EN 60601-1:2006/AC:2010 (IEC 60601-1:2005 Mod)" and "EN 60601-2-10:2000 (IEC 60601-2-10:1987)" listed as harmonized standards.
Whereas the FDA has "AAMI / ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012 And, A2:2010/(R)2012 (IEC 60601-1:2005, Mod)" and "IEC 60601-2-10 Edition 2.0 2012-06" listed as consensus standards.
So, both seem to be recognizing a 3rd-edition variant of the general standard, but for the particular standard (-2-10), Europe is recognizing the 1st edition (1987), whereas the US FDA is recognizing the 2nd edition (2012).
Is this correct? If so, it appears that the version of the general standard has no bearing on the versions of particulars and collaterals you choose...
I'm trying to get my head around how versions of collateral and particular standards of relate to the general 60601-1 version...
Is there a simple relationship?
For example:
Europe currently has "EN 60601-1:2006/AC:2010 (IEC 60601-1:2005 Mod)" and "EN 60601-2-10:2000 (IEC 60601-2-10:1987)" listed as harmonized standards.
Whereas the FDA has "AAMI / ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012 And, A2:2010/(R)2012 (IEC 60601-1:2005, Mod)" and "IEC 60601-2-10 Edition 2.0 2012-06" listed as consensus standards.
So, both seem to be recognizing a 3rd-edition variant of the general standard, but for the particular standard (-2-10), Europe is recognizing the 1st edition (1987), whereas the US FDA is recognizing the 2nd edition (2012).
Is this correct? If so, it appears that the version of the general standard has no bearing on the versions of particulars and collaterals you choose...