International Standard
ISO/TR 80002-2:2017
Medical device software — Part 2: Validation of software for medical device quality systems
Reference number
ISO/TR 80002-2:2017
Edición 1
International Standard
Vista previa
ISO/TR 80002-2:2017
No disponible en español
Publicado (Edición 1, 2017)

ISO/TR 80002-2:2017

ISO/TR 80002-2:2017
CHF 216
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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.

Informaciones generales

  •  : Publicado
     : 2017-06
    : Norma Internacional publicada [60.60]
  •  : 1
     : 84
  • ISO/TC 210
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