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Withings BP-801 Manual

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This device complies with the following normative documents :
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
medical devices as amended by Directive 2007/47/EC
– EN ISO 13485: 2003/AC: 2009: Medical devices – Quality management
systems – Requirements for regulatory purposes (ISO 13485:2003)
Reference to standards contd.
– EN ISO14971: 2012: Medical devices – Application of risk management
to medical devices (ISO 14971: 2007, Corrected version 2007-10-01)
– IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601-1:
2006 + AC (2010): Medical electrical equipment – Part 1: General
requirements for basic safety and essential Performance
– EN1060-3:1997+A1: 2005 + A2: 2009: Non-invasive sphygmomano-
meters, Part 3: Supplementary requirements for electromechanical
blood pressure measuring systems
– EN1060-4: 2004 Non-invasive sphygmomanometers. Test procedures
to determine the overall system accuracy of automated non-invasive
sphygmomanometers
– IEC/EN 60601-1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home
healthcare environment
– IEC 80601-2-30: 2009 (First Edition) for use in conjunction with
IEC 60601-1:2005
– EN 80601-2-30: 2010/ANSI/AAMI 80601-2-30: 2009: Particular
requirements for the basic safety and essential performance of
automated non-invasive sphygmomanometers
– EN300328 V1.8.1 Electromagnetic compatibility and Radio spectrum
Matters (ERM); Wideband transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band and using wide band
modulation techniques; Harmonized EN covering the essential require-
ments of article 3.2 of the R&TTE Directive
– EN301489-1-3 V1.9.2 (2011) Electromagnetic compatibility and Radio
spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard
for radio equipment and services; Part 1: Common technical requirements
– EN301489-1-17 V2.2.1(2012) Electromagnetic compatibility and Radio
spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard
for radio equipment and services; Part 1: Common technical requirements
– EN60601-1-2: 2007 CISPR: 2011: Medical electrical equipment:
Part 1‐2: General requirements for basic safety and essential
performance-collateral standard electromagnetic compatibility
– EN 55011: 2009/A1: 2010: Industrial, scientic and medical equipment –Radio-
frequency disturbance characteristics – Limits and methods of measurement
– FCC part B 15B: 2013 Electromagnetic Compatibility
– FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC Rule Part: 15.247 Cat: DTS (BT4.0)
– EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Eva-
luation and testing within a risk management process (ISO 10993-1:2009)
– ANSI/AAMI SP10: 2002/A1 2003(R) 2008: Manual, electronic or
automated sphygmomanometers
– ANSI/AAMI/ISO 81060‐2:2009 Non‐invasive sphygmomanometers
Part 2: Clinical validation of automated measurement type
REFERENCE TO STANDARDS
… 12 …


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