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EVS-EN 62304:2006

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Medical device software - Software life-cycle processes

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.

See standard on harmoneeritud standard Direktiivi 93/42/EÜ (meditsiiniseadmed) mõistes, arvestades järgmist märkust:
(*): Selles  Euroopa standardis ei tarvitse sisalduda direktiivi 2007/47/EÜ nõuded.

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