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.
General information
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Current status : PublishedPublication date : 2006-05
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Edition : 1Number of pages : 151
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Technical Committee:Quality management and corresponding general aspects for medical devices
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- ICS :
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Medical equipment in general
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IT applications in health care technology
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Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Now under review
IEC 62304:2006 -
Corrigenda/Amendments
IEC 62304:2006/Amd 1:2015
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Will be replaced by
IEC/CD 62304