Contact Information - Salter BPA-9301-EU Manual De Usuario

CONTACT INFORMATION

For more information about our products, please visit www.salterhousewares.co.uk
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
Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management to medical devices
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 Information supplied by the manufacturer of medical devices
EN 60601-1:2006+A1:2013/ 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
non-automated measurement type
Performance EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
requirements 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
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
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