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ISO/TR 80002-2:2017

Medical device software - Part 2: Validation of software for medical device quality systems
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ISO/TR 80002-2:2017

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

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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.

SDO ISO: International Organization for Standardization
Document Number ISO/TR 80002
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 210
Publish Date Document Id Type View
Not Available ISO/TR 80002-2:2017 Revision