NEN - NPR-ISO/TR 80002-2
Medical device software - Part 2: Validation of software for medical device quality systems
|Publication Date:||1 June 2017|
|ICS Code (IT applications in health care technology):||35.240.80|
|ICS Code (Medical equipment in general):||11.040.01|
NPR-ISO/TR 80002-2 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.