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Specifies life cycle processes including software development, software maintenance, software risk management, software configuration management, and software problem resolution requirements for medical device software. Also requires manufacturers to assign one of three defined safety classes to the software system, and makes normative reference to ANSI/AAMI/ISO 14971, Application of risk management to medical devices.

New! IEC 62304:2006 Checklist also available for purchase.
 

Document History

  1. AAMI/IEC 62304:2006

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    Medical device software - Software life cycle processes

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  2. AAMI SW68


    Medical device software - Software life cycle processes

    • Historical Version