IEC 62366:2007 医疗器械 - 可用性工程在医疗器械中的应用

标准编号：IEC 62366:2007

中文名称：医疗器械 - 可用性工程在医疗器械中的应用

英文名称：Medical devices - Application of usability engineering to medical devices

发布日期：2007-10-18

标准范围

指定制造商分析、指定、设计、验证和验证与医疗器械安全相关的可用性的过程。此可用性工程过程评估并减轻与正确使用和使用错误（即正常使用）相关的可用性问题所造成的风险。它可用于识别但不评估或减轻与异常使用相关的风险。如果符合本国际标准中详述的可用性工程过程，并且符合可用性验证计划中记录的验收标准，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，除非有客观证据相反。本国际标准不适用于与医疗器械使用有关的临床决策。

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.

标准预览图