26 MEDLINE | MDS4003
Complied Standards List
Risk management
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
Labeling
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 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
compatibility - 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 80601-2-30:2013 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/IEC 60601-1-6:2010+A1:2013 Medical
electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
EN 62366:2008/ IEC 62366-1:2015 Medical devices - Application
of usability engineering to medical devices
Software life-cycle
processes
EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device
software - Software life-cycle processes
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
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