BS PD ISO/TR 80002-2:2017适用于设备设计、测试、部件验收、， 制造、标签、包装、分销和投诉处理，或使任何其他 ISO 13485中描述的医疗器械质量体系方面。本文件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。它不适用于作为医疗设备的组件、部件或附件使用的软件，或本身是医疗设备的软件。交叉引用:ISO/IEC指南51:2014 ED3ISO 9000:2015ISO/IEC 12207:2008 Ed 2IEC 62304:2006/AMD1:2015IEC TR 80002-1:2009ISO 14971:2007ISO 13485:2016NIST 500-234:1996购买本文件时提供的所有当前修订版均包括在内。

BS PD 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.This document applies tosoftware used in the quality management system,software used in production and service provision, andsoftware used for the monitoring and measurement of requirements.It does not apply tosoftware used as a component, part or accessory of a medical device, orsoftware that is itself a medical device.Cross References:ISO/IEC Guide 51:2014 ED3ISO 9000:2015ISO/IEC 12207:2008 Ed 2IEC 62304:2006/AMD1:2015IEC TR 80002-1:2009ISO 14971:2007ISO 13485:2016NIST 500-234:1996All current amendments available at time of purchase are included with the purchase of this document.