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Complied European Standards List
Risk Management EN/ISO 14971:2007
Labeling EN 15223:2012
User Manual EN 1041:2008
General Requirements
for Safety
EN 60601-1:2006/AC2010
EN 60601-1-11:2010
Non-invasive
Sphygmomanometers
General
Requirements
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 1060-4:2004
Electromagnetic
Compatibility
EN 60601-1-2:2007/AC:2010
Software Lifetime EN 62304:2006/AC:2008
Usability EN 60601-1-6:2010
EMC Guidance
Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC
EMISSIONS – for all ME EQUIPMENT and ME SYSTEM
Manuel_BPM_book.indd 24 06/06/2014 10:21:22
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