GERATHERM Smart GT-1775, Manual

Page: 70 / 312

70
EN
Quality standards
Geratherm Medical AG is certified in accordance with DIN
EN ISO 13485 and fulfils the requirements of Council Di-
rective 93/42/EEC. It is therefore authorised to apply the
label Notified Body: TÜV Rheinland LGA Products
GmbH).
This blood pressure monitor complies with the following
standards:
Risk manage-
ment
EN ISO 14971:2012 / ISO 14971:2007
Medical devices – Application of risk manage-
ment to medical devices
Labelling
ISO 15223-1:2017
Medical devices – Symbols to be used with
medical device labels, labelling and information
to be supplied – Part 1: General requirements
Operating
instructions
EN 1041:2008 +A1:2013
Information supplied by the manufacturer of
medical devices
General safety
requirements
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
- Collateral standard: Requirements for medical
electrical equipment and medical electrical sys-
tems used in the home healthcare environment
Electromag-
netic compat-
ibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014
Medical electrical equipment – Parts 1-2: Gen-
eral requirements for basic safety and essential
performance
– Collateral standard: Electromagnetic distur-
bances – requirements and tests
Performance
requirements
EN ISO 81060-1:2012
Non-invasive sphygmomanometers – Part 1: Re-
quirements and test methods for non-automated
measurement type
EN 1060-3:1997+A2:2009
Non-invasive sphygmomanometers – Part 3:
Supplementary requirements for electromechan-
ical blood pressure measuring systems
IEC 80601-2-30:2013
Medical electrical devices - Part 2-3: Particular
requirements for the basic safety and essential
performance of non-invasive sphygmomano-
meters of non-automated measurement type