IEC/TR 80002-1:2009（E）提供了ISO 14971:2007《医疗器械-医疗器械风险管理应用于医疗器械软件》中要求的应用指南，参考IEC 62304:2006《医疗器械软件-软件生命周期过程》。它不会增加或改变ISO 14971:2007或IEC 62304:2006的要求。 IEC/TR 80002-1:2009（E）针对的是在医疗设备/系统中包含软件时需要执行风险管理的风险管理从业人员，以及需要了解如何满足ISO 14971中所述风险管理要求的软件工程师。 国际标准化组织（ISO 14971）在全球范围内得到监管机构的认可，被广泛认为是执行医疗器械风险管理时使用的主要标准。IEC 62304:2006对要求其使用的ISO 14971进行了规范性引用。这两个标准的内容为本技术报告提供了基础。应注意的是，尽管ISO 14971和本技术报告侧重于医疗设备，但本技术报告可用于对医疗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。 IEC/TR 80002-1:2009不打算用作监管检查或认证评估活动的基础。

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.