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General Reference Resources: Basic Reference

Subject guide with links to general reference resources including: dictionaries, medical dictionaries, quotations, acronyms, and more!

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ISO Standards

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