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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Recognized Standards

On August 6, 2013, the FDA issued a federal register notice Modifications to the List of Recognized Standards, Recognition List Number: 0321 that recognizes voluntary consensus standards to help support and strengthen the interoperability and cybersecurity of networked and connected medical devices.

  • IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).  
  • AAMI / ANSI / IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.  
  • ANSI / RESNA WC/Vol. 2-1998, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters. 
  • ANSI C63:19:2001, Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids