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U.S. Department of Health and Human Services

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Standards and Guidance Documents Impacted by the Laboratory of Software Engineering

  • IEC 80001: Risk Management of Medical Devices in Networks
  • IEC 60601-1: Medical Electrical Equipment: General Requirements for Safety
  • IEC 60601-1-10: Safety of Closed Loop Physiologic Controllers
  • IEC 60601-2-24: Particular Requirements for the Safety of Infusion Pumps and Controllers
  • ISO/IEC PDTR 24772.2: Information Technology – Guidance to Avoiding Vulnerabilities in Programming Languages
  • UL 1998: Software in Programmable Components
  • IEC 61508: Functional safety of programmable electronic systems
  • AAMI TIR32: Medical device software risk management
  • ASTM F2761-09: Safety of Devices in the Integrated Clinical Environment
  • Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
  • General Principles of Software Validation
  • Guidance for Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software
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