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ISO/TR 80002-2:2017

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

NORM herausgegeben am 13.6.2017

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The information about the standard:

Designation standards: ISO/TR 80002-2:2017
Publication date standards: 13.6.2017
The number of pages: 84
Approximate weight : 283 g (0.62 lbs)
Country: International technical standard
Kategorie: Technische Normen ISO

Annotation of standard text ISO/TR 80002-2:2017 :

Description / Abstract: 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.