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 disturbances - 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 blood pressure Part 3: Supplementary requirements
for electromechanical blood pressure measuring system
Clinical investigation
EN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine
the overall system accuracy of automated non-invasive sphygmomanometers
Usability
EN 60601-1-6:2010+A1:2015/IEC 60601-6:2010+A1:2013 Medical electrical equipment -Part
1-6: General requirements for basic safety and essential performance - Collateral standard:
Usability
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+ A1: 2015 Medical device software - Software
life cycle processes
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English
Summary of Contents for BDA432
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