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safety and essential performance - Collateral standardUsability[42] IEC 62366-12015 Medical devices - Part 1Application of usability engineering to medical devices[43]  HYPERLINK "https://webstore.iec.ch/publication/24664" \t "http://www.iec.ch/dyn/www/_blank" IEC TR 62366-22016 Medical devices - Part 2Guidance on the application of usability engineering to medical devices [44] ANSI HE742009 Human factors design process for medical devices[45] ANSI HE752013 Human factors engineering - Design of medical devices[46] FDA Mobile Medical Applications  Guidance for Industry and Food and Drug Administration Staff 2015.2.9[47] FDA General WellnessPolicy for Low Risk Devices  Guidance for Industry and Food and Drug Administration Staff 2016.7.29[48] FDA Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff 2016.2.3[49] FDA List of Highest Priority Devices for Human Factors Review - Draft Guidance for 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