论文部分内容阅读
本文介绍了有源医疗器械可用性和可用性工程的含义以及可用性工程的工作过程并结合风险管理的要求,以及可用性工程和风险管理之间的关系。对于风险管理过程而言,与可用性关联的问题,诸如与安全性有关的特征,应在风险分析时予以考虑;可用性确认的结果最好也在剩余风险的评价中考虑;风险管理过程中的生产后信息的评价宜包括可用性。可用性工程过程的目标是在用户接口的可用性方面提供对患者、操作者和其他人员的安全。因此,可用性工程应及早进行并持续贯穿医疗器械的整个开发周期,最终形成可用性工程文档;可用性工程文档可以是风险管理文档的一部分。
This article describes the implications of availability and availability engineering for active medical devices and the working processes for usability engineering in combination with risk management requirements and the relationship between usability engineering and risk management. For the risk management process, the issues associated with usability, such as those related to safety, should be considered in the risk analysis; the results of the usability validation are also best considered in the evaluation of the residual risk; the production in the risk management process The post-information evaluation should include usability. The goal of usability engineering processes is to provide security to patients, operators, and other people in terms of usability of user interfaces. As a result, usability engineering should continue as early as and throughout the entire development cycle of a medical device, culminating in a usability engineering document that can be part of a risk management document.