BS EN 62366-2008 医疗设备.医疗设备可用性工程的应用

标准号：BS EN 62366-2008
中文标准名称：医疗设备.医疗设备可用性工程的应用
英文标准名称：Medical devices - Application of usability engineering to medical devices
标准类型：C30
发布日期：2008/4/30 12:00:00
实施日期：2008/4/30 12:00:00
中国标准分类号：C30
国际标准分类号：11.040.01
引用标准：ISO 14971-2007
适用范围：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.