HoMedics TMB-1491-S Mode D'emploi page 15

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CONTACT INFORMATION
For more information about our products, please visit www.homedics.co.uk
Model: TMB-1491-S
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China
Authorized European Representative:
MDSS - Medical Device Safety Service GmbH
Schiffgraben 41,
30175 Hannover,
Germany
COMPLIED STANDARDS LIST
EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management to medical devices
Risk management
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device
Labeling
labels, labelling and information to be supplied. Part 1 : General requirements
User manual EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
EN 60601-1:2006+A1:2013+A12:2014/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1:
General General requirements for basic safety and essential performance
Requirements EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General
for Safety requirements for basic safety and essential performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements
Electromagnetic
for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -
compatibility
Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for
Performance non-automated measurement type
requirements 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
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall
Clinical system accuracy of automated non-invasive sphygmomanometers
investigation ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated
measurement type
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6:
Usability General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
Software life-cycle EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle
processes processes
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk
management process
Bio-compatibility ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization
Imported into the UK by:
FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP
Imported into the EU by:
FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE
Customer Support: +44(0)1732 378557 support@homedics.co.uk
15 I GB