医用电气设备.第1-6部分:安全的通用要求.附属标准:使用性

[中文适用范围]： 医疗实践越来越多地使用医用电气设备来观察和治疗患者。由于医疗电气设备可用性不足而导致的使用错误已日益引起人们的关注。可用性工程 [外文原描述]： Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. use errors caused by inadequate medical electrical equipment usability have become an increasing cause for concern. The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is part of the process of risk control. This Collateral Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide medical electrical equipment safety. It addresses normal use and use errors but excludes abnormal use.