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

Medical device software - Software life cycle processes - Amendment only

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.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.