BS PD ISO/TR 80002-2:2017

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 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 ED3
ISO 9000:2015
ISO/IEC 12207:2008 Ed 2
IEC 62304:2006/AMD1:2015
IEC TR 80002-1:2009
ISO 14971:2007
ISO 13485:2016
NIST 500-234:1996


All current amendments available at time of purchase are included with the purchase of this document.