Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012

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Ash Watson

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#1
#1
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!
 
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primavesvera

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When we submitted 510(k) in 2018, we didn't have any problem. The test report was done by a certified lab based on the EN version of the standard.
But it was in 2018, so maybe to wait for someone with recent experience (I think their pilot project for accreditation of laboratories is still on-going).
 
A

Ash Watson

Starting to get Involved
#3
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primavesvera said:
When we submitted 510(k) in 2018, we didn't have any problem. The test report was done by a certified lab based on the EN version of the standard.
But it was in 2018, so maybe to wait for someone with recent experience (I think their pilot project for accreditation of laboratories is still on-going).
Click to expand...
Thanks primavesvera, so I can probably proceed against EN version without too much risk for the time being.
Was wondering mainly if there are any glaring differences in documentation or specifications in the ES version
 
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