標準號：BS EN 62366-2008
中文標準名稱：醫療設備.醫療設備可用性工程的應用
英文標準名稱：Medical devices - Application of usability engineering to medical devices
標準類型：C30
發布日期：2008/4/30 12:00:00
實施日期：2008/4/30 12:00:00
中國標準分類號：C30
國際標準分類號：11.040.01
引用標準：ISO 14971-2007
適用范圍：This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify,design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. ThisUSABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problemsassociated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify butdoes not assess or mitigate RISKS associated with ABNORMAL USE.NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE.If the USABILITY ENGINEERING PROCESS detailed in this International Standard has beencomplied with and the acceptance criteria documented in the USABILITY VALIDATION plan havebeen met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated withUSABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVEEVIDENCE to the contrary (see 4.1.2).This International Standard does not apply to clinical decision-making relating to the use of aMEDICAL DEVICE.