List Of Harmonized En Standards - Omron HBP-1120 New Product Information Sheet

Packaging specifications from Explanation Diagram
Package
Main Unit
Package
Master Carton
EAN code
The above mentioned medical device belongs to Class IIa (MDD Annex IX Rule 10)
potential risk class.
Medical Device Directive (MDD) 93/42/EEC :
2011/65/EU Restriction of Hazardous Substances (RoHS) : EN 50581 :2012
Amount Approx. weight
1 510 g
1 1050 g
10 11.5 kg
4015672111318

List of Harmonized EN Standards

Applicable Directives & Standards:
EN ISO 15223:1:2016
EN 1041:2008+A1:2013
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-1:2006+A1:2013
EN 60601-1-6:2010+A1 :2015
EN 80601-2-30 :2010+A1 :2015
EN 62304:2006+A1:2015
EN 62366:2008+A1:2015
EN ISO 10993-1:2009/AC:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 14971:2012
EN ISO 81060-2 :2014
EN ISO 13485 :2016
PM-1794-01-06/2018
Approx. dimensions
W x D x H, mm
130 x 175 x 120 mm
149 x 142 x 178 mm
735 x 315 x 211 mm
11