Withings BP 800 Manuel D'utilisation page 24

Certifications
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
This device complies with the following normative documents :
• IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
• EN60601-1: 2006; ANSI/AAMI ES60601-1: 2005:Medical Electrical Equipment - Part 1: Generalre-
quirement for basic safety and essential performance
• EN1060-1: 1995 with Amendment A2: 2009:Non-invasive sphygmomanometer, Part 1: General
requirements
• EN1060-3: 1997 with Amendment A2: 2009:Non-invasive sphygmomanometers, Part 3: Supple-
mentary requirements for electro-mechanical blood pressure measuring systems
• EN55011: 2007 + A2: 2007; EN60601-1-2: 2007; FCC 47 CFR PART 18: Electromagnetic Compatibi-
lity
• ANSI/AAMI SP10:2002Manual, electronic, or automated sphygmomanometers; safety and perfor-
mance requirements.
• Canadian Medical Device Licence (class 2 device)
P/N: BP-800
Type BF Applied part (cuff )
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