NEN - NPR-ISO/TR 80002-2

Medical device software - Part 2: Validation of software for medical device quality systems

active, Most Current
Organization: NEN
Publication Date: 1 June 2017
Status: active
Page Count: 96
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

Document History

NPR-ISO/TR 80002-2
June 1, 2017
Medical device software - Part 2: Validation of software for medical device quality systems
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...
Advertisement