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PM-1824-04-10/2019
AC Adapter (HHP-BFH01)
List of Harmonized EN Standards
The device is classified as a medical device, Class IIa (MDD Article 9 Annex IX Rule 10)
Applicable Directives: Medical Device Directive (MDD) 93/42/EEC
EN 1041:2008+A1:2013
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-1:2006+A1:2013
EN 60601-1-2:2015
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 10993-1:2009/AC:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
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