Standard

IEC 62304:2006 ED1

Current

Note: Latest version: IEC 62304:2006+AMD1:2015 CSV

Existing or new amendments and versions must be purchased separately.

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Abstract

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.

Products specifications

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