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60.60 Standard published Nov 14, 2008
CENELEC
CLC/TC 62 Electrical equipment in medical practice
European Norm
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.
Legislation related to this standard
PUBLISHED
EN 62304:2006
PUBLISHED
EN 62304:2006/corrigendum Nov. 2008
60.60
Standard published
Nov 14, 2008
IN_DEVELOPMENT
prEN IEC 62304