inventum BDA432 Instruction Manual page 54

Electromagnetic compatibility
Performance requirements
Clinical investigation
Usability
Software life-cycle processes
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EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2:
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EN 1060-3: 1997+A2: 2009 Non-invasive blood pressure Part 3: Supplementary requirements
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the overall system accuracy of automated non-invasive sphygmomanometers
EN 60601-1-6:2010+A1:2015/IEC 60601-6:2010+A1:2013 Medical electrical equipment -Part
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IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices
EN 62304: 2006/AC: 2008 / IEC 62304: 2006+ A1: 2015 Medical device software - Software
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