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IEC 62304 Ed. 1.0 b:2006
M00001228
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IEC 62304 Ed. 1.0 b:2006 Medical device software - Software life cycle processes
standard by International Electrotechnical Commission, 05/09/2006
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New! IEC 62304 checklist is now available. Click here to learn more about how this checklist can help you!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.