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. | File Size : | 1
file
, 3.8 MB |
| ISBN(s) : | 9780580764257 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 94 |
| Product Code(s) : | 30251827, 30251827, 30251827 |
| Published : | 10/31/2017 |
| Same As : | BS PD ISO/TR 80002-2:2017 |
