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and damage caused by improper handling, accidents, not following
the operating instructions or self-maintained alterations made to the
device. The warranty is only valid upon presentation of the warranty
card with purchase date and stamp of trade organization.
COMPLIED STANDARDS LIST
Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices
-Application of risk management to medical devices
Labeling EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical
devices. Symbols to be used with medical device labels,
labelling and information to be supplied. Part 1 : General
requirements
User manual EN 1041:2008 Information supplied by the manufacturer
of medical devices
General Require-
ments for Safety
EN 60601-1:2006+A1:2013/ IEC 60601-
1:2005+A1:2012 Medical electrical equipment - Part
1: General requirements for basic safety and essential
performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical
electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral
standard: Requirements for medical electrical equip-
ment and medical electrical systems used in the home
healthcare environment
Electromagnetic
compatibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical
electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic disturbances - Requirements
and tests
Performance re-
quirements
EN ISO 81060-1:2012 Non-invasive sphygmoma-
nometers - Part 1: Requirements and test methods for
non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmoma-
nometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical
equipment- Part 2-30: Particular requirements for the
basic safety and essential performance of automated
non-invasive sphygmomanometers
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