Duronic BPM120, Manual

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Contact Information
Complied European Standards List
Distributed by:
Company: SHINEMART LTD
Address: Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB, UK.
Manufactured by:
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,
528437, Guangdong, China.
Authorized European Representative:
Company: MDSS - Medical Device Safety Service GmbH Address: Schiffgraben 41,
30175 Hannover, Germany.
Risk Management
EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management to medical
devices
Labelling
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 +A1:2013 Information supplied by the manufacturer of medical devices
General
Requirements 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 equipment 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
Requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods
for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - 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
Clinical Investigation
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the
overall system accuracy of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated
measurement type
Usability
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6:
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
Processes
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6:
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
Bio-compatibility
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a
risk management process
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