医疗器械 可用性工程在医疗器械中的应用

[中文适用范围]： 本国际标准规定了制造商分析、指定、设计、验证和验证可用性的流程，因为它与医疗器械的安全相关。该可用性工程过程评估并减轻由与正确使用和使用错误（即正常使用）相关的可用性问题引起的风险。它可用于识别但不能评估或减轻与异常使用相关的风险。注：就本标准而言，可用性（见 3.17）仅限于用户界面的特性。如果本国际标准中详述的可用性工程过程已得到遵守，并且可用性验证计划中记录的验收标准已得到满足（见 5.9），则 ISO 14971 中定义的与医疗器械可用性相关的剩余风险被认为是可接受的，除非有相反的客观证据（见 4.1.2）。本国际标准不适用于与医疗器械使用相关的临床决策。 [外文原描述]： Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.