IEC TR 80002-3:20 14是一份技术报告（TR），描述了医疗器械的软件生命周期流程。医疗器械软件生命周期流程源自IEC 62304:2006，具有相应的安全等级。它们已与ISO/IEC 12207:2008的软件开发生命周期过程保持一致，并在此完全符合ISO/IEC 24774:2010。这三个标准的内容为本TR提供了基础。本TR不:-涉及现有相关标准已经涵盖的领域，例如与用于构建本TR的四个标准相关的国际标准（见参考书目）； -FDA指导文件；或 -软件开发工具。本TR描述了医疗器械软件开发的过程参考模型，其范围仅限于IEC 62304中描述的生命周期过程:2006.工艺名称与IEC 62304:2006中的工艺名称一致。附录B中提供的映射对于IEC 62304:2006（基于ISO/IEC 12207:1995）和ISO/IEC 12207:2008之间的一致性至关重要，旨在解决两个标准之间的详细规范关系。本技术报告不打算作为监管检查或认证评估活动的依据。

IEC TR 80002-3:2014 which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010. The content of these three standards provides the foundation of this TR. This TR does not:
- address areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography);
- FDA guidance documents; or
- software development tools. This TR describes the process reference model for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006. The process names correspond to those of IEC 62304:2006. The mappings provided in Annex B are essential for the alignment between IEC 62304:2006 (which is based on ISO/IEC 12207:1995) and ISO/IEC 12207:2008, developed to address the detailed normative relationship between the two standards. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.