60.60 Standard published Jun 13, 2017
ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices
Technical Report
35.240.80 IT applications in health care technology | 11.040.01 Medical equipment in general
Published
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.
PUBLISHED
ISO/TR 80002-2:2017
60.60
Standard published
Jun 13, 2017
