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IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package

IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package

The IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package specifies the process of identifying, controling and monitoring risk and hazards associated with medical device software. It also defines the life cycle requirements for medical device software, set of processes, activities, and tasks establishing a common framework for medical device software life cycle processes. IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package is applicable 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. It includes:
ISO 14971:2007
IEC 62304 Ed. 1.0 b:2006
IEC 62304 Amd.1 Ed. 1.0 b:2015
IEC/TR 80002-1 Ed. 1.0 en:2009
ISO/DIS 14971:2018

IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package includes:

Content Provider
International Electrotechnical Commission [IEC]


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