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Abstract Preview

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.


General information

  • Status :  Published
    Publication date : 2017-06
  • Edition : 1
    Number of pages : 84
  • Technical Committee
    :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • ICS :
    11.040.01
    Medical equipment in general
    35.240.80
    IT applications in health care technology

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A standard is reviewed every 5 years



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    ISO/TR 80002-2:2017

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