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ANSI/AAMI/IEC 62304:2006 and A1:2016

CONSOLIDATED TEXT - Medical device software - Software life cycle processes

Includes Amendment 1. This standard 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 describes processes that are intended to be applied to software which executes on a processor or which is executed by other software (for example an interpreter) which executes on a processor.

Association for the Advancement of Medical Instrumentation [aami]

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