ISO/TR 80002-2:2017适用于设备设计、测试、组件验收、制造、标签、包装、分销和投诉处理中使用的任何软件，或ISO 13485中描述的医疗设备质量体系的任何其他方面的自动化软件。 ISO/TR 80002-2:2017适用于 -质量管理体系中使用的软件， -生产和服务提供中使用的软件，以及 -用于监视和测量需求的软件。 它不适用于 -用作医疗设备组件、部件或附件的软件，或 -软件本身就是一种医疗设备。

ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485. ISO/TR 80002-2:2017 applies to - software used in the quality management system, - software used in production and service provision, and - software used for the monitoring and measurement of requirements. It does not apply to - software used as a component, part or accessory of a medical device, or - software that is itself a medical device.