AAMI TIR49-2013 Design of training and instructional materials for medical devices used in non-clinical environments
IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC 82079-1:2012 Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14915-1:2002 Software ergonomics for multimedia user interfaces - Part 1: Design principles and framework
ISO 14915-2:2003 Software ergonomics for multimedia user interfaces - Part 2: Multimedia navigation and control
ISO 14915-3:2002 Software ergonomics for multimedia user interface - Part 3: Media selection and combination
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 16781:2013 Space systems.Simulation requirements for control system
ISO 9241-110:2006 Ergonomics of human-system interaction - Part 110: Dialogue principles
ISO/TR 24971:2013 Medical devices - Guidance on the application of ISO 14971
BS PD IEC/TR 62366-2:2016 history
2016BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices