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EVS-EN 62304:2006+A1:2015

Medical device software - Software life-cycle processes

General information
Valid from 15.11.2019
Base Documents
IEC 62304:2006; EN 62304:2006; EN 62304:2006/AC:2008; IEC 62304:2006/A1:2015; EN 62304:2006/A1:2015
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.11.2019
Main + amendment
04.11.2015
Amendment
03.04.2009
Corrigendum
06.10.2006
Main
This standard 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.
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