I have BS EN 60601-1:2006+A12:2014, but the device being developed is destined for US market, so ANSI/AAMI ES60601-1:2005 (R2012) applies.
Can anyone advise/comment on where in general the differences - if any - exist and whether complying to the european version (particularly during design, development and verification) will cover for the FDA's Recognised Consensus Standard.
...the ANSI/AAMI document is expensive!
Can anyone advise/comment on where in general the differences - if any - exist and whether complying to the european version (particularly during design, development and verification) will cover for the FDA's Recognised Consensus Standard.
...the ANSI/AAMI document is expensive!