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ISO/TR 80002-2:2017

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

Jun 13, 2017

General information

60.60     Jun 13, 2017


ISO/TC 210

Technical Report

35.240.80     11.040.01  




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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.

Life cycle


ISO/TR 80002-2:2017
60.60 Standard published
Jun 13, 2017