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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.
 

Document History

  1. AAMI/IEC 62304:2006 & A1:2016

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    Medical device software - Software life cycle processes - Consolidated Text

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  2. AAMI/IEC 62304:2006


    Medical device software - Software life cycle processes

    • Historical Version
  3. AAMI SW68


    Medical device software - Software life cycle processes

    • Historical Version