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ISO TR 80002-2:2017 ED1

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ISO/TR 80002-2:2017(E) 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.

Dokumentinformasjon

  • Standard fra IEC
  • Publisert:
  • Utgave: 1
  • Versjon: 1
  • Varetype: TR
  • ICS 11.040.01
  • ICS 35.240.80
  • ISO TC TC 62/SC 62A

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