美利体育登录入口官网:IEC/TR 80002-3:2014
医疗器械软件 - 第3部分:医疗器械软件生命周期过程的过程参考模型（Iec 62304）
Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
- 标准号
- IEC/TR 80002-3:2014
- 发布
- 2014年
- 国际标准分类(ICS)
- 35.240.80 信息技术在医药卫生技术中的应用
- 总页数
- 32页
- 发布单位
- 国际电工委员会
- 当前最新
- IEC/TR 80002-3:2014
- 引用标准
- IEC 62304:2006 ISO/IEC 12207:2008
- 本体
- 过程参考模型
- 适用范围
- This part of IEC 80002, 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 PRM 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.
| 术语 | 描述 |
|---|---|
| 软件安全类 software safety class | 根据可能造成的伤害程度对软件进行的分类：A类（无伤害或健康损害可能）、B类（非严重伤害可能）、C类（死亡或严重伤害可能）。 |