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Mayo Clinic licenses a number of standards from the International Standards Organization. The following standards are available for download on the internal Integrity and Compliance Office page.
IEC 62304 Ed. 1.1 b:2015 Medical Device Software - Software Life Cycle Processes
IEC 62366-1 Ed. 1.0 b:2015 Medical devices - Part 1: Application of Usability Engineering to Medical Devices
IEC 82304-1 Ed. 1.0 b:2016 Health Software - Part 1: General Requirements for Product Safety
IEC/TR 80002-1 Ed. 1.0 en:2009 Medical Device Software - Part 1: Guidance on the Application of ISO 14971 to Medical Device Software
ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
ISO 14971:2007 (also see ISO/DIS 14971: 2019) Medical Devices - Application of Risk Management to Medical Devices
ISO/IEC 14764:2006 Software Engineering - Software Life Cycle Processes - Maintenance
ISO/DIS 14971: 2019 (also see ISO 14971: 2007) Medical Devices - Application of Risk Management to Medical Devices
ISO 15189:2012 Medical Laboratories - Requirements for Quality and Competence
ISO/IEC 17043:2010 Conformity Assessment - General Requirements for Proficiency Testing