PD ISO/TR 80002-2:2017

This standard PD ISO/TR 80002-2:2017 Medical device software is classified in these ICS categories:

• 35.240.80 IT applications in health care technology
• 11.040.01 Medical equipment in general

This document 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.