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CONTACT INFORMATION
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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 labels,
Labeling
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 requirements for
for Safety
basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
Electromagnetic
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic
compatibility
safety and essential performance - Collateral standard: Electromagnetic disturbances - 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 electro-
requirements
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 system
Clinical
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: General
Usability
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 ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro
Bio-compatibility
cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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