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EN 62304:2006

Current

Current

The latest, up-to-date edition.

Medical device software - Software life-cycle processes

Published date

07-12-2006

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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.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current

Standards Relationship
BS EN 60601-2-28:2010 Identical
UNE-EN 62304:2007 Identical

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