Omron HEM-7143-E - Regulatory Compliance and Standards; Medical Device Regulation (EU)2017;745; RoHS Directive 2011;65;EU; Directive 2014;53;EU

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PM-2044-01-08/2021
List of Classification, Applicable Directives/Regulations and
Harmonized EN Standards
The device is classified according to Medical Device Regulation
(EU)2017/745 ANNEX VIII, Rule 10 as Class IIa medical device.
Regulation (EU)2017/745 (Medical Device Regulation)
-EN 60601-l:2006+Al:2013
-EN 60601-1-2:2015
-EN 60601-l-6:2010+Al:2015
-EN 60601-1-11: 2015
-EN 1060-l:1995+A2:2009
-EN 1060-3: 1997+A2:2009
-EN IEC 80601-2-30:2019
-EN ISO 81060-2:2019+Al:2020
-EN 62304:2006+Al:2015
-EN 62366-1:2015
-EN ISO 15223-1:2016
-EN 1041:2008+A1:2013
-EN ISO 14971:2012
-EN ISO 10993-5:2009
-EN ISO 10993-10:2013
-EN ISO 13485:2016
Directive 2011/65/EU(RoHS)
-EN ISO 63000:2018
Directive 2014/53/EU
-EN 300 328 V2.2.2
-EN 301 489-1 V2.2.3
-EN 301 489-17 V3.2.4
-EN 62479:2010
-EN IEC 62368-1:2020+A11:2020