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NEK ISO TR 80002-2:2017

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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 NEK
  • Publisert:
  • Utgave: 1.0
  • Versjon: 1
  • Varetype: TR
  • Products.Specs.pages
  • ICS 11.040.01
  • ICS 35.240.80
  • National Committee NEK/NK62

Produktrelasjon

  • Adoptert fra: ISO TR 80002-2:2017