医疗器械软件.第1部分:ISO 14971在医疗器械软件中的应用指南

[中文适用范围]： “本技术报告为 ISO 14971:2007@ 医疗器械中包含的要求的应用提供指导？参考 IEC 62304:2006@ 医疗器械软件？将医疗器械风险管理应用于医疗器械软件？软件生命周期它不会添加@或以其他方式更改@ISO 14971:2007 或 IEC 62304:2006 的要求。本技术报告针对的是当软件包含在医疗设备/系统中时需要执行风险管理的风险管理从业者@ 以及需要了解如何满足 ISO 14971 中提出的风险管理要求的软件工程师。ISO 14971@ 得到全球监管机构的认可@ 被广泛认为是执行医疗设备风险管理时使用的主要标准。IEC 62304:2006 @ 规范性地引用了 ISO 14971，要求其使用。这两个标准的内容为本技术报告提供了基础。需要注意的是，即使 ISO 14971 和本技术报告重点关注医疗器械@，也可以使用本技术报告为医疗保健环境中的所有软件实施安全风险管理流程，无论其是否被归类为医疗设备。本技术报告不涉及：？C 现有或计划中的标准已涵盖的领域@例如警报@可用性工程@网络@等； ?C 生产或质量管理系统软件；或C软件开发工具。本技术报告不作为监管检查或认证评估活动的依据。出于本技术报告的目的@“应该”用于表示在满足要求的几种可能性中@其中一种被推荐为特别合适@而不提及或排除其他@或者某种行动方案是优选的，但不一定需要。该术语不应被解释为指示要求。” [外文原描述]： IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1:2009 is not intended to be used as the basis of regulatory inspection or certification assessment activities.