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Standard

IEC 62304:2006 ED1

Attuale

Nota: Ultima versione: IEC 62304:2006+AMD1:2015 CSV

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Astratto

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

Specifiche dei prodotti

  • Standard da IEC
  • Pubblicato:
  • Edizione: 1
  • Tipo di documento: IS
  • Pagine
  • Publisher IEC
  • Distributor IEC
  • ICS 11.040.01
  • International TC TC 62/SC 62A