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Complex IEC 60601-1 gap assessment

RA Guy

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#1
I am trying to perform a gap assessment between versions of IEC60601-1 being applied by a test house and that recognized by Health Canada.

The test lab is testing to:
ANSI/AAMI ES60601-1:2005 (R)2012, A1: 2012
and
CAN/CSA-22.2 No. 60601-1:14
(IEC 60601-1:2005+A1:2012, MOD)

Health Canada recognizes:
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1:2005-Ed.3.0/Cor.2:2007
and
IEC 60601-1:2012-Ed.3.1
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

I've tried to read up on this, but have only managed to confuse myself. Wondering if anyone has done this type of an exercise and if there are any helpful hints or suggested resources.

Thanks
RA Guy
 
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