Complied Standards List - ETEKCITY TMB-1583-BS User Manual

Complied Standards List

EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management
Risk management
to medical devices
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with
Labeling 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
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-
General Requirements 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:
Electromagnetic
General requirements for basic safety and essential performance - Collateral standard:
compatibility
Electromagnetic disturbances - Requirements and tests
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
Performance sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
requirements 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
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EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures
to determine the overall system accuracy of automated non-invasive
Clinical investigation
sphygmomanometers 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 requirements for basic safety and essential performance - Collateral
Usability
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 -
processes Software life-cycle 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
Bio-compatibility
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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