IEC 62366的这一部分规定了制造商分析、规定和开发的过程 以及评估医疗设备的可用性，因为它与安全有关。这种可用性 工程（人为因素工程）过程允许制造商评估 并减轻与正常使用相关的风险，即正确使用和使用错误。 它可用于识别但不评估或减轻与异常使用相关的风险。包含以下内容:BS EN 62366-1:2015

This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with NORMAL USE, i.e., CORRECT USE and USE ERROR. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.Incorporates the following:BS EN 62366-1:2015