Standard

ISO TR 80002-2:2017 ED1

Current

Existing or new amendments and versions must be purchased separately.

Language
Services

Abstract

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.

Products specifications

  • Standard from IEC
  • Published:
  • Edition: 1
  • Document type: TR
  • Pages
  • Publisher: IEC
  • Distributor: IEC
  • ICS: 11.040.01
  • ICS: 35.240.80
  • International TC: TC 62/SC 62A