Omron X3 Comfort

10
PM-2078-01-10/2021
AC Adapter (HHP-BFH01)
List of Harmonized EN Standards
The device is classified as a medical device, Class IIa (MDR Annex VIII Rule 10)
Applicable Directives:
Medical Device Regulation (EU) 2017/745
EN 1041:2008+A1:2013
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2=2009
EN 60601-1:2006+A1:2013+A12:2014
EN 60601-1-2:2015
EN 60601-1-6:2010+A1:2015
EN 60601-1-11:2015
EN 62304:2006+A1:2015
EN 62366-1:2015
EN 80601-2-30:2010+A1:2015
EN ISO 10993-1:2020