scope:

NPR-IEC/TR 62366-2, which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information. This technical report has two main themes: • information about efficient ways to implement elements required by IEC 62366-1:2015; and • additional information, in particular how USABILITY relates to attributes such as TASK EFFICIENCY and USER satisfaction, which can enhance a MEDICAL DEVICE'S commercial success. This technical report discusses the business benefits of USABILITY ENGINEERING, the basics of applicable analysis and design techniques, MEDICAL DEVICE USABILITY EVALUATION approaches, efficient ways to address USABILITY ENGINEERING project implementation issues (e.g. integration into a quality management system) and provides a list of useful USABILITY ENGINEERING resources. This technical report also can be useful for other healthcare products (e.g. drug packaging and drug LABELLING, drug-MEDICAL DEVICE combination products and health IT software).