Status : Published

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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.

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General information

  • Status
     : Published
    Publication date
     : 2017-06
    Stage
    : International Standard published [60.60]
  • Edition
     : 1
    Number of pages
     : 84
  • Technical Committee :
    ISO/TC 210
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