If my device has been evaluated with all standards (IEC 60601-1: 2012 or IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012
IEC 60601-1-6:2010 + A1:2013
IEC 60601-1-8: 2006 (Second Edition) + A1: 2012
IEC 60601-1-11:2015 (Second Edition)
IEC 62304:2006 (First Edition) + A1:2015
ISO 80601-2-69: 2014 (First Edition)
EN 60601-1:2006+A11+A1+A12
EN 60601-1-6:2010+A1
EN 60601-1-8:2007+A1
EN 60601-1-11:2015
EN ISO 80601-2-69:2014
EN 62304:2006+A1
ANSI/AAMI ES60601-1:2005+A2(R2012) +A1
CAN/CSA-C22.2 No. 60601-1:14
CAN/CSA-C22.2 No. 60601-1-6:11 + A1
CAN/CSA-C22.2 No. 60601-1-8-08 (R18)
CAN/CSA-C22.2 No. 60601-1-11:15
CAN/CSA-C22.2 No. 80601-2-69:16
CAN/CSA-CEI/IEC 62304:1
and My device is following the
Directive 93/42/EEC.
and All the standards are harmonized
So I can use the CE mark on my device to sell in Europe and just have A declaration of conformity to the Directive 93/42/EEC. to register the device in Europe
Please Need some advice
Thanks ------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
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