Contact Information
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Complied European Standards List
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical
device labels, labelling and information to be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to provide information
EN 60601-1: 2006+A1:2013 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC/EN 60601-1-11: 2010 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
IEC/EN 80601-2-30:2009 Medical electrical equipment - Part 2-30:
Particular requirements for the basic safety and essential performance of
automated noninvasive sphygmomanometers
IEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral
standard:Electromagnetic compatibility - Requirements and tests
EN 1060-1:1995+A2:2009 Non-invasive blood pressure Part 1: General
requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part 3:
Supplementary requirements for electromechanical blood pressure measuring
system
EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system
Interventional accuracy of the testing process
IEC/EN 60601-1-6: 2010 Medical electrical equipment -- Part 1-6: General
requirements for basic safety and essential performance - Collateral
Standard: Usability
IEC/EN 62366: 2007 Medical devices - Application of usability engineering
to medical devices
IEC/EN 62304:2006+AC: 2008 Medical device software - Software life
cycle processes
Authorized European Representative:
Manufactured by:
Company:
Address:
Company:
MDSS - Medical Device Safety Service GmbH
Address:
Schiffgraben 41, 30175 Hannover, Germany
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
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CONTACT INFORMATION
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