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 otheraspect of a medical device quality system as described in ISO 13485.This document 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.
Cross References:ISO/IEC Guide 51:2014 ED3ISO 9000:2015ISO/IEC 12207:2008 Ed 2 IEC 62304:2006/AMD1:2015IEC TR 80002-1:2009ISO 14971:2007ISO 13485:2016NIST 500-234:1996
