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Electromagnetic compatibility
EN 60601-1-2: 2007 Medical electrical equipment: Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirement 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 Medical electrical equipment -Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
EN 62366: 2008 Medical devices - Application of usability engineering to medical devices
Software life-cycle processes EN 62304: 2006+AC: 2008 Medical device software - Software life cycle processes
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